Test your GMP knowledge by taking a PIC/S GMP Quiz:
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PIC/S GMP Quiz 2022
Quiz-summary
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Test your GMP knowledge with the new 2022 version of the GMP quiz. There are 15 multiple choice questions, and the quiz will take about 5 minutes to complete.
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Question 1 of 15
1. Question
Quality Management is a wide-ranging concept which covers matters which individually or collectively influence the quality of a product.
Correct
GMP reference is PE 009-15, Part I, Chapter 1, Pharmaceutical Quality System, clause 1.1 “Quality Management is a wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective of ensuring that medicinal products are of the quality required for their intended use. Quality Management therefore incorporates Good Manufacturing Practice.”
Incorrect
Incorrect
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Question 2 of 15
2. Question
GMP applies to the lifecycle stages, from the:
Correct
GMP reference is PE 009-15, Part I, Chapter 1, Pharmaceutical Quality System, clause 1.2 “GMP applies to the lifecycle stages from the manufacture of investigational medicinal products, technology transfer, commercial manufacturing through to product discontinuation. However the Pharmaceutical Quality System can extend to the pharmaceutical development lifecycle stage as described in ICH Q10, which while optional, should facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activities.”
Incorrect
Incorrect
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Question 3 of 15
3. Question
Who must ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorisation?
The responsibilities of an Authorise Person may be delegated but only to:Correct
GMP reference is PE 009-15, Part I, Chapter 2, Personnel, clause 2.6 “The duties of the Authorised Person(s) are described in the national requirements and can be summarised as follows:
- An Authorised Person must ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in that country and in accordance with the requirements of the Marketing Authorisation.”
Incorrect
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Question 4 of 15
4. Question
Personal medication in the production area should be:
Correct
GMP reference is PE 009-15, Part I, Chapter 2, Personnel, clause 2.19 “Eating, drinking, or smoking, or the storage of food, drink, smoking materials or personal medication in the production and storage areas should be prohibited. In general, any unhygienic practice within the manufacturing areas or any other area where the product might be adversely affected should be forbidden.”
Incorrect
Incorrect
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Question 5 of 15
5. Question
Quality Risk Management principles should be used to assess and control the risks of cross-contamination.
Correct
GMP reference is PE 009-15, Part I, Chapter 3, Premises and Equipment, clause 3.6 “Cross-contamination should be prevented for all products by appropriate design and operation of manufacturing facilities. The measures to prevent cross-contamination should be commensurate with the risks. Quality Risk Management principles should be used to assess and control the risks.”
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Incorrect
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Question 6 of 15
6. Question
What is the purpose of a protocol?
Correct
GMP reference is PE 009-15, Part I, Chapter 4, Documentation, “Required GMP Documentation (by Type)” section “Protocols: Give instructions for performing and recording certain discreet operations.”
Incorrect
Incorrect
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Question 7 of 15
7. Question
Incoming materials and finished goods should be:
Correct
GMP reference is PE 009-15, Part I, Chapter 5, Production, clause 5.5 “Incoming materials and finished products should be physically or administratively quarantined immediately after receipt or processing, until they have been released for use or distribution.”
Incorrect
Incorrect
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Question 8 of 15
8. Question
All the in-process controls, including those made in the production area by production personnel should be performed according to methods approved by:
Correct
GMP reference is PE 009-15, Part I, Chapter 6, Quality Control, clause 6.18 “All the in-process controls, including those made in the production area by production personnel, should be performed according to methods approved by Quality Control and the results recorded.”
Incorrect
Incorrect
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Question 9 of 15
9. Question
Contract Giver is not responsible for the reviewing and assessing the records and the results related to the outsourced activities.
Correct
GMP reference is PE 009-15, Part I, Chapter 7, Outsourced activities, clause 7.5 “The Contract Giver should be responsible for reviewing and assessing the records and the results related to the outsourced activities. He/she should also ensure, either by himself/herself, or based on the confirmation of the Contract Acceptor’s Authorised Person, that all products and materials delivered to him/her by the Contract Acceptor have been processed in accordance with GMP and the Marketing Authorisation.”
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Question 10 of 15
10. Question
In the case on investigational medicinal products:
Correct
GMP reference is PE 009-15, Part I, Chapter 8, Complaints and product recall, clause 8.24 “In the case of investigational medicinal products, all trial sites should be identified and the countries of destination should be indicated. In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product should, in cooperation with the sponsor, inform the marketing authorisation holder of any quality defect that could be related to the authorised medicinal product.”
Incorrect
Incorrect
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Question 11 of 15
11. Question
Out-of-Specification API batches:
Correct
GMP reference is PE 009-15, Part II, Production and In-Process Controls, clause 8.41 “Out-Of-Specification batches should not be blended with other batches for the purpose of meeting specifications. Each batch incorporated into the blend should have been manufactured using an established process and should have been individually tested and found to meet appropriate specifications prior to blending.”
Incorrect
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Question 12 of 15
12. Question
Where a computerised system replaces a manual operation, there should be no resultant decrease in:
Correct
GMP reference is PE 009-15, Annex 11, Computerised Systems, Principle section “Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, product control or quality assurance. There should be no increase in the overall risk of the process.”
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Question 13 of 15
13. Question
When a computerised system is used for recording certification and batch release:
Correct
GMP reference is PE 009-15, Annex 15, Qualification and Validation, General section “Data supporting qualification and/or validation studies which were obtained from sources outside of the manufacturers own programmes may be used provided that this approach has been justified and that there is adequate assurance that controls were in place throughout the acquisition of such data.”
Incorrect
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Question 14 of 15
14. Question
Premises and equipment used for the manufacturing of investigational medicinal products:
Correct
GMP reference is PE 009-15, Annex 13, Manufacture of investigational medicinal products, clause 17 “Production processes for investigational medicinal products are not expected to be validated to the extent necessary for routine production but premises and equipment are expected to be qualified.”
Incorrect
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Question 15 of 15
15. Question
Data supporting qualification and/or validation studies which were obtained from other sources than the manufacturers own programmes may be used:
Correct
GMP reference is PE 009-15, Annex 15, Qualification and Validation, General section “Data supporting qualification and/or validation studies which were obtained from sources outside of the manufacturers own programmes may be used provided that this approach has been justified and that there is adequate assurance that controls were in place throughout the acquisition of such data.”
Incorrect
Incorrect
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PIC/S GMP Quiz 2021
Quiz-summary
0 of 15 questions completed
Questions:
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Test your GMP knowledge with the new 2021 version of the GMP quiz. There are 15 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 15
1. Question
Which part of the PIC/S guideline was adopted by the Therapeutical Good Administration (TGA) of Australia for manufacture of Active Pharmaceutical Ingredients?
Correct
PE009-14 Part II, is the part adopted by the TGA for manufacturing of API
Incorrect
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Question 2 of 15
2. Question
There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System?
Correct
GMP reference is PE-009-14 Chapter 1 Pharmaceutical Quality System, Clause 1.6 “There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself.”.
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Question 3 of 15
3. Question
Quality Control DOES NOT require that:
Correct
Staff are regularly and sufficiently supplied with caffeine, it is not part of the Quality Control ethos as this does not contribute in ensuring “sampling, specifications and testing, and with the organisation, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.”. Refer to PE-009-14 Part 1 Clause 1.9
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Question 4 of 15
4. Question
Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas
Correct
GMP reference is PE009-14 Part 1 Chapter 2: Personnel, Clause 2.13 “Visitors or untrained personnel should, preferably, not be taken into the production and quality control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.”
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Question 5 of 15
5. Question
Premises and equipment MUST BE:
Correct
GMP reference is PE009-14 Part 1 Chapter 3: Premises and Equipment, Principle: “Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products.”
Incorrect
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Question 6 of 15
6. Question
Highly active materials or products should be stored outside.?
Correct
GMP reference is PE-009-14 Part 1 Chapter 3: Premises and Equipment, Clause 3.24 “Highly active materials or products should be stored in safe and secure areas.”
Incorrect
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Question 7 of 15
7. Question
Which of the listed document types ARE required GMP documentation?
Correct
All types are required GMP documentation see PE009-14 Part 1, Chapter 4: Documentation: Required GMP Documentation (by Type).
Incorrect
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Question 8 of 15
8. Question
It should be clearly defined which record is related to each manufacturing activity
Correct
GMP reference is PE-009-14 Chapter 4 Documentation, Clause 4.10 “It should be clearly defined which record is related to each manufacturing activity and where this record is located. Secure controls must be in place to ensure the integrity of the record throughout the retention period and validated where appropriate.”
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Question 9 of 15
9. Question
Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure:
Correct
GMP reference is PE-009-14 Part 1 Chapter 5 Production, Clause 5.8. “Checks on yields, and reconciliation of quantities, should be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.”. Note: If a discrepancy does occur, it should be reported to a supervisor as soon as it is discovered.
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Question 10 of 15
10. Question
The supply chain and traceability records for each active substance (including active substance starting materials) should be available.
Correct
GMP reference is PE009-14 Part 1 Chapter 5: Production, Clause 5.29: “The supply chain and traceability records for each active substance (including active substance starting materials) should be available and be retained by the manufacturer of the medicinal product.”.
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Question 11 of 15
11. Question
The reprocessing of rejected products is common practice.
Correct
GMP reference is PE009-14 Part 1 Chapter 5: Production, Clause 5.67 “The reprocessing of rejected products should be exceptional. It is only permitted if the quality of the final product is not affected, if the specifications are met and if it is done in accordance with a defined and authorised procedure after evaluation of the risks involved. Record should be kept of the reprocessing.”
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Question 12 of 15
12. Question
Sample containers should bear a label indicating the contents:
Correct
GMP reference is PE009-14 Part 1 Chapter 6: Production, Clause 6.13: “Sample containers should bear a label indicating the contents, with the batch number, the date of sampling and the containers from which samples have been drawn. They should be managed in a manner to minimize the risk of mix-up and to protect the samples from adverse storage conditions.
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Question 13 of 15
13. Question
Who is responsible for ensuring that processes are in place to assure control of outsourced activities?
Correct
GMP reference is PE009-14, chapter 7: Outsourced Activities, clause 7.4 “ The Pharmaceutical Quality System of the Contract Giver should include the control and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities.”
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Question 14 of 15
14. Question
Sufficient trained personnel and resources should be made available for the review of complaints and quality defects?
Correct
GMP reference is PE009-14, chapter 8: Complaints and Product Recall, clause 8.2 “Sufficient trained personnel and resources should be made available for the handling, assessment, investigation and review of complaints and quality defects and for implementing any risk-reducing actions. Sufficient trained personnel and resources should also be available for the management of interactions with Competent Authorities.”
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Question 15 of 15
15. Question
Internal Audits (self-inspections) should be conducted in order to?
Correct
GMP reference is PE009-14, chapter 9: Self Inspections, clause 9.2 “Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.”
Incorrect
GMP reference is PE009-14, chapter 9: Self Inspections, clause 9.2 “Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.”
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PIC/S GMP Quiz 2020
Quiz-summary
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Test your GMP knowledge with the new 2020 version of the GMP quiz. There are 17 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 17
1. Question
Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System?
Correct
GMP reference is PE-009-14 Chapter 1 Pharmaceutical Quality System, Clause 1.5 “Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place, adequately resourced and that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management’s leadership and active participation in the Pharmaceutical Quality System is essential. This leadership should ensure the support and commitment of staff at all levels and sites within the organisation to the Pharmaceutical Quality System”.
Incorrect
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Question 2 of 17
2. Question
Product Quality Reviews DOES NOT include review of:
Correct
Company office supplies requests and expenditure, is not part of the Product Quality Review as this does not contribute in verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product or help to highlight any trends and to identify product and process improvements. Refer to PE-009-14 Part 1 Clause 1.10 “Regular periodic or rolling quality reviews of all authorised medicinal products, including export only products, should be conducted with the objective of verifying the consistency of the existing process, the appropriateness of current specifications for both starting materials and finished product, to highlight any trends and to identify product and process improvements.”
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Question 3 of 17
3. Question
The Personnel Hygiene program implemented in the facility SHOULD include:
Correct
GMP reference is PE-009-14 Part 1 Chapter 2: Personnel, Clause 2.15 “Detailed hygiene programmes should be established and adapted to the different needs within the factory. They should include procedures relating to the health, hygiene practices and clothing of personnel. These procedures should be understood and followed in a very strict way by every person whose duties take him into the production and control areas. Hygiene programmes should be promoted by management and widely discussed during training sessions.”
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Question 4 of 17
4. Question
Specific training IS NOT required to handle or work with highly active or toxic materials
Correct
GMP reference is PE009-14 Part 1 Chapter 2: Personnel, Clause 2.12 “Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, infectious or sensitising materials are handled, should be given specific training.”
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Question 5 of 17
5. Question
Premises and equipment MUST BE:
Correct
GMP reference is PE009-14 Part 1 Chapter 3: Premises and Equipment, Principle: “Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products.”
Incorrect
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Question 6 of 17
6. Question
Rejected, Returned or Recalled product can be stored with finished product once it is correctly labelled?
Correct
GMP reference is PE-009-14 Part 1 Chapter 3: Premises and Equipment, Clause 3.23 “Segregated areas should be provided for the storage of rejected, recalled or returned materials or products.”
Incorrect
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Question 7 of 17
7. Question
Which of the listed document types ARE required GMP documentation?
Correct
Site Master File, SOP and CofA are required GMP documentation see PE009-14 Part 1, Chapter 4: Documentation: Required GMP Documentation (by Type).
Incorrect
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Question 8 of 17
8. Question
Specific requirements apply for retention of production batch documentation?
Correct
GMP reference is PE-009-14 Chapter 4 Documentation, Clause 4.11 “Specific requirements apply to batch documentation which must be kept for one year after expiry of the batch to which it relates or at least five years after certification of the batch by the Authorised Person, whichever is the longer. For investigational medicinal products, the batch documentation must be kept for at least five years after the completion or formal discontinuation of the last clinical trial in which the batch was used. Other requirements for retention of documentation may be described in legislation in relation to specific types of product (e.g. Advanced Therapy Medicinal Products) and specify that longer retention periods be applied to certain documents.”
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Question 9 of 17
9. Question
Which of the following SHOULD be quarantined until they are released for use or distribution:
Correct
GMP reference is PE-009-14 Part 1 Chapter 5 Production, Clause 5.5. “Incoming materials and finished products should be physically or administratively quarantined immediately after receipt or processing, until they have been released for use or distribution.”
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Question 10 of 17
10. Question
For each delivery of starting material the containers should be checked for integrity of package, including tamper evident seal where relevant and each batch of the same material delivered must be considered as separate batch for sampling and testing.
Correct
GMP reference is PE009-14 Part 1 Chapter 5: Production, Clause 5.30: “For each delivery of starting material the containers should be checked for integrity of package, including tamper evident seal where relevant, and for correspondence between the delivery note, the purchase order, the supplier’s labels and approved manufacturer and supplier information maintained by the medicinal product manufacturer. The receiving checks on each delivery should be documented. Clause 5.31: If one material delivery is made up of different batches, each batch must be considered as separate for sampling, testing and release.
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Question 11 of 17
11. Question
The manufacturer SHOULD report to the TGA marketing authorization holder any constraints in manufacturing operations which may result in abnormal restriction in the supply?
Correct
GMP reference is PE009-14 Part 1 Chapter 5: Production, Clause 5.71 “The manufacturer should report to the marketing authorisation holder (MAH) any constraints in manufacturing operations which may result in abnormal restriction in the supply. This should be done in a timely manner to facilitate reporting of the restriction in supply by the MAH, to the relevant competent authorities, in accordance with its legal obligations.”
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Question 12 of 17
12. Question
The sampling of materials and finished products must be conducted in accordance with written procedures that may have information on:
Correct
GMP reference is PE009-14 Part 1 Chapter 6: Production, Clause 6.11: “The sample taking should be done and recorded in accordance with approved written procedures that describe: (i) The method of sampling; (ii) The equipment to be used; (iii) The amount of the sample to be taken; (iv) Instructions for any required sub-division of the sample; (v) The type and condition of the sample container to be used; (vi) The identification of containers sampled; (vii) Any special precautions to be observed, especially with regard to the sampling of sterile or noxious materials; (viii) The storage conditions; (ix) Instructions for the cleaning and storage of sampling equipment.”
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Question 13 of 17
13. Question
GMP reference is PE009-14, chapter 7: Outsourced Activities, clause 7.4 “ The Pharmaceutical Quality System of the Contract Giver should include the control and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities.”
Correct
GMP reference is PE009-14, chapter 7: Outsourced Activities, clause 7.4 “ The Pharmaceutical Quality System of the Contract Giver should include the control and review of any outsourced activities. The Contract Giver is ultimately responsible to ensure processes are in place to assure the control of outsourced activities.”
Incorrect
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Question 14 of 17
14. Question
There should be written procedures describing the actions to be taken upon receipt of a complaint?
Correct
GMP reference is PE009-14, chapter 8: Complaints and Product Recall, clause 8.5 “There should be written procedures describing the actions to be taken upon receipt of a complaint. All complaints should be documented and assessed to establish if they represent a potential quality defect or other issue.”
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Question 15 of 17
15. Question
Internal Audits (self-inspections) can be conducted by?
Correct
GMP reference is PE009-14, chapter 9: Self Inspections, clause 9.2 “Self-inspections should be conducted in an independent and detailed way by designated competent person(s) from the company. Independent audits by external experts may also be useful.”
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Question 16 of 17
16. Question
Where would I find specific requirements for the manufacturer of special groups of products? e.g. Sterile Preparations
Correct
GMP reference is PE009-14 Part 1 Chapter 2: Personnel, Clause 2.22: “Any specific requirements for the manufacture of special groups of products, for example sterile preparations, are covered in the annexes.”
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Question 17 of 17
17. Question
Which part of the PIC/S guideline was adopted by the Therapeutical Good Administration (TGA) of Australia for manufacture of Active Pharmaceutical Ingredients?
Correct
PE009-14 Part II, is the part adopted by the TGA for manufacturing of API
Incorrect
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GMP Engineering Quiz 2020:
How familiar are you with the common concepts of Pharmaceutical Manufactuing? If you feel you are up to the challenge, test your knowledge of Contamination Control, HVAC, Product Containment and Pharmacutical Water Systems. This one is tough, so be warned!
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Question 1 of 25
1. Question
Which of the following options is a form of Secondary Containment?
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Question 2 of 25
2. Question
A potent Active Pharmaceutical Ingredient must be dispensed and transported from the Dispensary to the Manufacturing Room where it is then transferred into an enclosed batch mixing vessel. What would be the best container and transfer method for this material?
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Question 3 of 25
3. Question
Purified Water (PW) meets the quality requirements for sterile treatments, such as injectable products.
Hint
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Question 4 of 25
4. Question
Which of the following statements is NOT true with regards to Water For Injection?
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Question 5 of 25
5. Question
Pharmaceutical Water should continuously circulate with a turbulent flow rate to help prevent the formation of biofilm.
Hint
PIC/S PE009-12 Annex 1 Section 53
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Question 6 of 25
6. Question
Which one of the following questions should we know the answer(s) to before designing a Purified Water system?
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Question 7 of 25
7. Question
On pharmaceutical water distribution loops, an air break should exist between the Point-Of-Use valves and the downstream manufacturing processes?
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Question 8 of 25
8. Question
Which of the following statements is true?
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Question 9 of 25
9. Question
Pre-treatment processes and systems will vary based upon the attributes of the drinking water supply (which has different qualities from region to region).
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Question 10 of 25
10. Question
Monitoring water systems requires evaluation and responses to:
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Question 11 of 25
11. Question
Mould is the number one risk factor for contamination of a clean room due to temperature and moisture factors.
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Question 12 of 25
12. Question
The life cycle phases of bacteria are as follows:
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Question 13 of 25
13. Question
Terminal sterilisation means the product sterilised in its final container.
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Question 14 of 25
14. Question
Quality Assurance testing guarantees that our products are sterile?
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Question 15 of 25
15. Question
A Contamination Control Strategy includes considerations such as facility design, gowning procedures as well as operating & cleaning procedures amongst others.
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Question 16 of 25
16. Question
CIP systems draw pharmaceutical-grade water into a break tank, where the water is heated or cooled as required. It is then pumped through pipework to sprayballs or product pathways to clean the equipment.
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Question 17 of 25
17. Question
Which of the following statements are true?
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Question 18 of 25
18. Question
Which sterilisation technique is suitable for temperature sensitive products?
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Question 19 of 25
19. Question
What does the acronym HVAC stand for?
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Question 20 of 25
20. Question
Why are airlocks employed between areas of different classifications?
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Question 21 of 25
21. Question
Pharmaceutical HVAC systems differ from commercial or industrial systems because they:
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Question 22 of 25
22. Question
In GMP guidelines, what is the recommended differential pressure between areas of different classification?
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Question 23 of 25
23. Question
What is the primary purpose of Product Containment?
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Question 24 of 25
24. Question
Isolators can be used for a variety of applications including, dispensing of active ingredients, performing laboratory tests and to enclose filling lines?
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Question 25 of 25
25. Question
Where might we find information relating to a material’s hazards including Occupational Exposure Level and/or Hazard Category?
Leaderboard: GMP Engineering Quiz 2020
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PIC/S GMP Quiz 2019
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Test your GMP knowledge with the new 2019 version of the GMP quiz. There are 13 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 15
1. Question
What is the current version of the PIC/s PE-009 Guide to Good Manufacturing Practice for Medicinal Products, that was adopted by the Therapeutical Good Administration of Australia in January of 2019?
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Question 2 of 15
2. Question
The size and complexity of a company operations does not affect the companies Pharmaceutical Quality System?
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Question 3 of 15
3. Question
Quality Risk Management can be applied retrospectively as well as proactively.
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Question 4 of 15
4. Question
Who has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place?
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Question 5 of 15
5. Question
Specific training is not required to handle or work with highly active or toxic materials
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Question 6 of 15
6. Question
Where would I find specific requirements for the manufacturer of special groups of products? e.g. Sterile Preparations
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Question 7 of 15
7. Question
Rejected, Returned or Recalled product can be stored with finished product once it is correctly labelled?
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Question 8 of 15
8. Question
What information should be clearly displayed on fixed pipework?
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Question 9 of 15
9. Question
How long should batch documentation be kept for Investigation Medicinal Products (IMPs)?
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Question 10 of 15
10. Question
An independent secondary verification should be performed for each dispensed material, as well as weight and volume checks
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Question 11 of 15
11. Question
When setting up packaging operations, particular attention should be given to the following:
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Question 12 of 15
12. Question
Upon completion of the packaging operation, any uncoded packaging not used during processing can be retained for future use?
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Question 13 of 15
13. Question
In outsourced activities who is responsible for ensuring that all product, materials and knowledge are suitable for their intended purpose?
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Question 14 of 15
14. Question
Who should a manufacturer inform if it is considering actions following a possible faulty manufacture, product degradation, detection of counterfeiting or any other serious quality problems?
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Question 15 of 15
15. Question
Recall processes should be able to be implemented at least once a year?
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Test your GMP knowledge with the new 2018 version of the GMP quiz. There are 13 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 13
1. Question
Where human error is identified as the cause of a deviation, it is not necessary to consider if the error was influenced by the lack of a procedure to control the activity.
Correct
Correct!
GMP reference: PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.4, page 3
“(xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems.
This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.4, page 3
“(xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems.
This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.”
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Question 2 of 13
2. Question
A periodic Management Review process of the Pharmaceutical Quality System is an optional activity that senior management can use to identify continual improvement opportunities.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.6, page 3
“There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself”.
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.6, page 3
“There should be periodic management review, with the involvement of senior management, of the operation of the Pharmaceutical Quality System to identify opportunities for continual improvement of products, processes and the system itself”.
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Question 3 of 13
3. Question
It is a requirement to ensure that the Supply Chain between an active substance supplier and the dosage form manufacturer is secure and integral and mapped to identify risks?
Correct
Correct! The GMP reference is GMP reference PE 009-13, Part I, Chapter 1 Product Quality Review, 1.10, page 6
“A review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances”PE009-13, the PIC/S guide to GMP for medicinal products TGA interpretation and expectations for demonstrating compliance:
“Manufacturers of dosage forms should have a clear understanding of the approved suppliers of active substances, and each entity and their responsibility in the supply chain between the site of manufacture and receipt (clause 1.10(i)). Supply chains should be adequately secure, integral and ensure that materials are transported under appropriate conditions. Supply chains should be mapped and any identified risks managed following the principles of quality risk management.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 1 Product Quality Review, 1.10, page 6
“A review of starting materials including packaging materials used in the product, especially those from new sources and in particular the review of supply chain traceability of active substances”PE009-13, the PIC/S guide to GMP for medicinal products TGA interpretation and expectations for demonstrating compliance:
“Manufacturers of dosage forms should have a clear understanding of the approved suppliers of active substances, and each entity and their responsibility in the supply chain between the site of manufacture and receipt (clause 1.10(i)). Supply chains should be adequately secure, integral and ensure that materials are transported under appropriate conditions. Supply chains should be mapped and any identified risks managed following the principles of quality risk management.”
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Question 4 of 13
4. Question
Once personnel are trained and assessed in a particular task, provided they perform the task on a regular basis they will only require further assessment when the SOP is updated.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 2 Personnel, 2.11, page 11
“Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 2 Personnel, 2.11, page 11
“Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
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Question 5 of 13
5. Question
Outsourced manufacturing activities are the only contracted activities that can affect the quality of medicinal product manufactured by a site.
Correct
Correct! The GMP reference is Refer to PE 009-13, Part I, Chapter 7 Outsourced Activities, 7.4, page 40
“The Pharmaceutical Quality System of the Contract Giver should include the control and review of any outsourced activities”
PE009-13, the PIC/S guide to GMP for medicinal products TGA interpretation and expectations for demonstrating compliance
“The title of chapter 7 has changed from ‘Contract manufacturer and analysis’ to ‘Outsourced activities’ in recognition of the fact that there are a number of outsourced (contracted) activities that may have a direct effect on the quality of medicinal product manufactured by a site. The previous title of the chapter restricted the extent of GMP controls to only outsourced manufacturing and testing services and thus did not appropriately manage the risk associated with other outsourced activities. Examples of outsourced activities that this chapter would now apply to include, but are not limited to:
-Contract manufacturing and analysis
-Maintenance and calibration services
-Providers of critical consumables, e.g. gowns, sterilised componentry
-Suppliers and manufacturers of raw materials, packaging materials and printed artwork
-Provision of training and consulting services
-Validation services associated with facilities, equipment, utilities, process and product design, qualification and validation
-Provision of transport and logistical services for products
-Contract cleaning and waste management services
-Contract pest control services
-Agencies that provide temporary or contract personnel”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 7 Outsourced Activities, 7.4, page 40
“The Pharmaceutical Quality System of the Contract Giver should include the control and review of any outsourced activities”
PE009-13, the PIC/S guide to GMP for medicinal products TGA interpretation and expectations for demonstrating compliance
“The title of chapter 7 has changed from ‘Contract manufacturer and analysis’ to ‘Outsourced activities’ in recognition of the fact that there are a number of outsourced (contracted) activities that may have a direct effect on the quality of medicinal product manufactured by a site. The previous title of the chapter restricted the extent of GMP controls to only outsourced manufacturing and testing services and thus did not appropriately manage the risk associated with other outsourced activities. Examples of outsourced activities that this chapter would now apply to include, but are not limited to:
-Contract manufacturing and analysis
-Maintenance and calibration services
-Providers of critical consumables, e.g. gowns, sterilised componentry
-Suppliers and manufacturers of raw materials, packaging materials and printed artwork
-Provision of training and consulting services
-Validation services associated with facilities, equipment, utilities, process and product design, qualification and validation
-Provision of transport and logistical services for products
-Contract cleaning and waste management services
-Contract pest control services
-Agencies that provide temporary or contract personnel”
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Question 6 of 13
6. Question
Consultants should have adequate: (select all answers that apply)
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 2 Personnel, 2.23, page 12
“Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants”.
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 2 Personnel, 2.23, page 12
“Consultants should have adequate education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records should be maintained stating the name, address, qualifications, and type of service provided by these consultants”.
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Question 7 of 13
7. Question
Which functional aspects of equipment should be calibrated and checked at defined intervals? (select all answers that apply)
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.41, page 16
“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.41, page 16
“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
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Question 8 of 13
8. Question
GMP documentation requirements apply to: (select all answers that apply)
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.1, page 18
“All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.1, page 18
“All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.”
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Question 9 of 13
9. Question
Personnel should record process data in a notebook whilst in the production area then transpose the information onto the batch record held in the manager’s office prior to completing their shift.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.8, page 19
“Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.8, page 19
“Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.”
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Question 10 of 13
10. Question
Which of the following documents are not required by GMP: (select all answers that apply)
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.29, page 25
“There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:
– Validation and qualification of processes, equipment and systems;
– Equipment assembly and calibration;
– Technology transfer;
– Maintenance, cleaning and sanitation;
– Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training;
– Environmental monitoring;
– Pest control;
– Complaints;
– Recalls;
– Returns;
– Change control;
– Investigations into deviations and non-conformances;
– Internal quality/GMP compliance audits;
– Summaries of records where appropriate (e.g. product quality review);
– Supplier audits.”Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.29, page 25
“There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:
– Validation and qualification of processes, equipment and systems;
– Equipment assembly and calibration;
– Technology transfer;
– Maintenance, cleaning and sanitation;
– Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training;
– Environmental monitoring;
– Pest control;
– Complaints;
– Recalls;
– Returns;
– Change control;
– Investigations into deviations and non-conformances;
– Internal quality/GMP compliance audits;
– Summaries of records where appropriate (e.g. product quality review);
– Supplier audits.” -
Question 11 of 13
11. Question
It is not necessary for tasks such as laboratory reagent preparation to have written procedures provided personnel are suitably qualified and trained.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 6 Quality control, 6.19, page 36
“Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared and controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data.”
Incorrect
Incorrect. Refer to PE 009-13, PE 009-13, Part I, Chapter 6 Quality control, 6.19, page 36
“Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared and controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data.”
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Question 12 of 13
12. Question
Written contracts covering outsourced activities should contain technical details in addition to commercial aspects.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 7 Outsourced activities, 7.1, page 40
“There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 7 Outsourced activities, 7.1, page 40
“There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.”
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Question 13 of 13
13. Question
Self inspections should be conducted into the following areas: (select all applicable statements)
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 9 Self inspection, 9.1, page 45
“Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 9 Self inspection, 9.1, page 45
“Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.”
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Test your GMP knowledge with the 2017 GMP quiz. There are 14 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 14
1. Question
Where human error is identified as the cause of a deviation, it is not necessary to consider if the error was influenced by the lack of a procedure to control the activity:
Correct
Correct! PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.4, page 3
““(xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems. This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles;”
Incorrect
Sorry, that’s the wrong answer. Refer to PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.4, page 3
““(xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems. This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles;”
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Question 2 of 14
2. Question
It is not a requirement of GMP for complaints from patients about products be investigated:
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.8, page 5
“(xi) Complaints about products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.”
Incorrect
False. Refer to PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.8, page 5
“(xi) Complaints about products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.”
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Question 3 of 14
3. Question
The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, have which of the following shared, or jointly exercised, responsibilities:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 2 Personnel, 2.9, page 10-11
“The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. These may include, subject to any national regulations:
(i) The authorisation of written procedures and other documents, including amendments;
(ii) The monitoring and control of the manufacturing environment;
(iii) Plant hygiene;
(iv) Process validation;
(v) Training;
(vi) The approval and monitoring of suppliers of materials;
(vii) The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
(viii) The designation and monitoring of storage conditions for materials and products;
(ix) The retention of records;
(x) The monitoring of compliance with the requirements of Good Manufacturing Practice;
(xi) The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
(xii) Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement;
(xiii) Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.”Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 2 Personnel, 2.9, page 10-11
(i) The authorisation of written procedures and other documents, including amendments;
(ii) The monitoring and control of the manufacturing environment;
(iii) Plant hygiene;
(iv) Process validation;
(v) Training;
(vi) The approval and monitoring of suppliers of materials;
(vii) The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
(viii) The designation and monitoring of storage conditions for materials and products;
(ix) The retention of records;
(x) The monitoring of compliance with the requirements of Good Manufacturing Practice;
(xi) The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
(xii) Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement;
(xiii) Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.” -
Question 4 of 14
4. Question
Once personnel are trained and assessed in a particular task, provided they perform the task on a regular basis they will only require further assessment when the SOP is updated.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 2 Personnel, 2.11, page 11
“Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 2 Personnel, 2.11, page 11
“Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
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Question 5 of 14
5. Question
When the configuration of a storage room changes, an assessment must be conducted into the potential impact and the temperature mapping repeated if necessary.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.19, page 15
“Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.19, page 15
“Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.”
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Question 6 of 14
6. Question
Maintenance of equipment is essential to GMP.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.34, page 16
“Manufacturing equipment should be designed, located and maintained to suit its intended purpose.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.34, page 16
“Manufacturing equipment should be designed, located and maintained to suit its intended purpose.”
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Question 7 of 14
7. Question
Equipment with which of the following functions should be calibrated and checked at defined intervals:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.41, page 16
“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.41, page 16
“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
-
Question 8 of 14
8. Question
GMP documentation requirements apply to:
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.1, page 18
“All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.1, page 18
“All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.”
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Question 9 of 14
9. Question
Personnel should record process data in a notebook whilst in the production area then transpose the information onto the batch record held in the manager’s office prior to completing their shift.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.8, page 19
“Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.8, page 19
“Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.”
-
Question 10 of 14
10. Question
Which of the following documents are not required by GMP:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 5 Production- General, 5.10, page 25
“There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:
– Validation and qualification of processes, equipment and systems;
– Equipment assembly and calibration;
– Technology transfer;
– Maintenance, cleaning and sanitation;
– Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training;
– Environmental monitoring;
– Pest control;
– Complaints;
– Recalls;
– Returns;
– Change control;
– Investigations into deviations and non-conformances;
– Internal quality/GMP compliance audits;
– Summaries of records where appropriate (e.g. product quality review);
– Supplier audits.”Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.29, page 25
“There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:
– Validation and qualification of processes, equipment and systems;
– Equipment assembly and calibration;
– Technology transfer;
– Maintenance, cleaning and sanitation;
– Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training;
– Environmental monitoring;
– Pest control;
– Complaints;
– Recalls;
– Returns;
– Change control;
– Investigations into deviations and non-conformances;
– Internal quality/GMP compliance audits;
– Summaries of records where appropriate (e.g. product quality review);
– Supplier audits.” -
Question 11 of 14
11. Question
Which measures can be used to avoid cross-contamination:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 5 Production, 5.19, page 27-8
“Cross-contamination should be avoided by appropriate technical or organisational measures, for example:
- a) Production in segregated areas (required for products such as penicillins, live vaccines, live bacterial preparations and some other biologicals), or by campaign (separation in time) followed by appropriate cleaning;
- b) Providing appropriate air-locks and air extraction;
- c) Minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
- d) Keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
- e) Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
- f) Using “closed systems” of production;
g) Testing for residues and use of cleaning status labels on equipment.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 5 Production, 5.19, page 27-8
“Cross-contamination should be avoided by appropriate technical or organisational measures, for example:
- a) Production in segregated areas (required for products such as penicillins, live vaccines, live bacterial preparations and some other biologicals), or by campaign (separation in time) followed by appropriate cleaning;
- b) Providing appropriate air-locks and air extraction;
- c) Minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
- d) Keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
- e) Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
- f) Using “closed systems” of production;
g) Testing for residues and use of cleaning status labels on equipment.”
-
Question 12 of 14
12. Question
It is not necessary for tasks such as laboratory reagent preparation to have written procedures provided personnel are suitably qualified and trained.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 6 Quality control, 6.19, page 36
“Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared and controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 6 Quality control, 6.19, page 36
“Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared and controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data.”
-
Question 13 of 14
13. Question
Written contracts covering outsourced activities should contain technical details in addition to commercial aspects.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 7 Outsourced activities, 7.1, page 40
“There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.”
Incorrect
Incorrect. Refer to: PE 009-13, Part I, Chapter 7 Outsourced activities, 7.1, page 40
“There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.”
-
Question 14 of 14
14. Question
Self inspections should be conducted into the following areas:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 9 Self inspection, 9.1, page 45
“Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.”
Incorrect
Incorrect. Refer to: PE 009-13, Part I, Chapter 9 Self inspection, 9.1, page 45
“Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.”
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Question 1 of 14
1. Question
Where human error is identified as the cause of a deviation, it is not necessary to consider if the error was influenced by the lack of a procedure to control the activity:
Correct
Correct! PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.4, page 3
““(xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems. This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles;”
Incorrect
Sorry, that’s the wrong answer. Refer to PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.4, page 3
““(xiv) An appropriate level of root cause analysis should be applied during the investigation of deviations, suspected product defects and other problems. This can be determined using Quality Risk Management principles. In cases where the true root cause(s) of the issue cannot be determined, consideration should be given to identifying the most likely root cause(s) and to addressing those. Where human error is suspected or identified as the cause, this should be justified having taken care to ensure that process, procedural or system based errors or problems have not been overlooked, if present. Appropriate corrective actions and/or preventive actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles;”
-
Question 2 of 14
2. Question
It is not a requirement of GMP for complaints from patients about products be investigated:
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.8, page 5
“(xi) Complaints about products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.”
Incorrect
False. Refer to PE 009-13, Part I, Chapter 1 Pharmaceutical Quality System, 1.8, page 5
“(xi) Complaints about products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.”
-
Question 3 of 14
3. Question
The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, have which of the following shared, or jointly exercised, responsibilities:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 2 Personnel, 2.9, page 10-11
“The heads of Production, Quality Control and where relevant, Head of Quality Assurance or Head of Quality Unit, generally have some shared, or jointly exercised, responsibilities relating to quality including in particular the design, effective implementation, monitoring and maintenance of the Pharmaceutical Quality System. These may include, subject to any national regulations:
(i) The authorisation of written procedures and other documents, including amendments;
(ii) The monitoring and control of the manufacturing environment;
(iii) Plant hygiene;
(iv) Process validation;
(v) Training;
(vi) The approval and monitoring of suppliers of materials;
(vii) The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
(viii) The designation and monitoring of storage conditions for materials and products;
(ix) The retention of records;
(x) The monitoring of compliance with the requirements of Good Manufacturing Practice;
(xi) The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
(xii) Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement;
(xiii) Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.”Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 2 Personnel, 2.9, page 10-11
(i) The authorisation of written procedures and other documents, including amendments;
(ii) The monitoring and control of the manufacturing environment;
(iii) Plant hygiene;
(iv) Process validation;
(v) Training;
(vi) The approval and monitoring of suppliers of materials;
(vii) The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities;
(viii) The designation and monitoring of storage conditions for materials and products;
(ix) The retention of records;
(x) The monitoring of compliance with the requirements of Good Manufacturing Practice;
(xi) The inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality;
(xii) Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement;
(xiii) Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.” -
Question 4 of 14
4. Question
Once personnel are trained and assessed in a particular task, provided they perform the task on a regular basis they will only require further assessment when the SOP is updated.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 2 Personnel, 2.11, page 11
“Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 2 Personnel, 2.11, page 11
“Besides the basic training on the theory and practice of the Pharmaceutical Quality System and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept.”
-
Question 5 of 14
5. Question
When the configuration of a storage room changes, an assessment must be conducted into the potential impact and the temperature mapping repeated if necessary.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.19, page 15
“Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.19, page 15
“Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.”
-
Question 6 of 14
6. Question
Maintenance of equipment is essential to GMP.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.34, page 16
“Manufacturing equipment should be designed, located and maintained to suit its intended purpose.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.34, page 16
“Manufacturing equipment should be designed, located and maintained to suit its intended purpose.”
-
Question 7 of 14
7. Question
Equipment with which of the following functions should be calibrated and checked at defined intervals:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 3 Premise and equipment, 3.41, page 16
“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 3 Premise and equipment, 3.41, page 16
“Measuring, weighing, recording and control equipment should be calibrated and checked at defined intervals by appropriate methods. Adequate records of such tests should be maintained.”
-
Question 8 of 14
8. Question
GMP documentation requirements apply to:
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.1, page 18
“All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.1, page 18
“All types of document should be defined and adhered to. The requirements apply equally to all forms of document media types. Complex systems need to be understood, well documented, validated, and adequate controls should be in place. Many documents (instructions and/or records) may exist in hybrid forms, i.e. some elements as electronic and others as paper based. Relationships and control measures for master documents, official copies, data handling and records need to be stated for both hybrid and homogenous systems. Appropriate controls for electronic documents such as templates, forms, and master documents should be implemented. Appropriate controls should be in place to ensure the integrity of the record throughout the retention period.”
-
Question 9 of 14
9. Question
Personnel should record process data in a notebook whilst in the production area then transpose the information onto the batch record held in the manager’s office prior to completing their shift.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 4 Documentation, 4.8, page 19
“Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.8, page 19
“Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.”
-
Question 10 of 14
10. Question
Which of the following documents are not required by GMP:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 5 Production- General, 5.10, page 25
“There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:
– Validation and qualification of processes, equipment and systems;
– Equipment assembly and calibration;
– Technology transfer;
– Maintenance, cleaning and sanitation;
– Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training;
– Environmental monitoring;
– Pest control;
– Complaints;
– Recalls;
– Returns;
– Change control;
– Investigations into deviations and non-conformances;
– Internal quality/GMP compliance audits;
– Summaries of records where appropriate (e.g. product quality review);
– Supplier audits.”Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 4 Documentation, 4.29, page 25
“There should be written policies, procedures, protocols, reports and the associated records of actions taken or conclusions reached, where appropriate, for the following examples:
– Validation and qualification of processes, equipment and systems;
– Equipment assembly and calibration;
– Technology transfer;
– Maintenance, cleaning and sanitation;
– Personnel matters including signature lists, training in GMP and technical matters, clothing and hygiene and verification of the effectiveness of training;
– Environmental monitoring;
– Pest control;
– Complaints;
– Recalls;
– Returns;
– Change control;
– Investigations into deviations and non-conformances;
– Internal quality/GMP compliance audits;
– Summaries of records where appropriate (e.g. product quality review);
– Supplier audits.” -
Question 11 of 14
11. Question
Which measures can be used to avoid cross-contamination:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 5 Production, 5.19, page 27-8
“Cross-contamination should be avoided by appropriate technical or organisational measures, for example:
- a) Production in segregated areas (required for products such as penicillins, live vaccines, live bacterial preparations and some other biologicals), or by campaign (separation in time) followed by appropriate cleaning;
- b) Providing appropriate air-locks and air extraction;
- c) Minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
- d) Keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
- e) Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
- f) Using “closed systems” of production;
g) Testing for residues and use of cleaning status labels on equipment.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 5 Production, 5.19, page 27-8
“Cross-contamination should be avoided by appropriate technical or organisational measures, for example:
- a) Production in segregated areas (required for products such as penicillins, live vaccines, live bacterial preparations and some other biologicals), or by campaign (separation in time) followed by appropriate cleaning;
- b) Providing appropriate air-locks and air extraction;
- c) Minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
- d) Keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
- e) Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
- f) Using “closed systems” of production;
g) Testing for residues and use of cleaning status labels on equipment.”
-
Question 12 of 14
12. Question
It is not necessary for tasks such as laboratory reagent preparation to have written procedures provided personnel are suitably qualified and trained.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 6 Quality control, 6.19, page 36
“Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared and controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data.”
Incorrect
Incorrect. Refer to PE 009-13, Part I, Chapter 6 Quality control, 6.19, page 36
“Special attention should be given to the quality of laboratory reagents, solutions, glassware, reference standards and culture media. They should be prepared and controlled in accordance with written procedures. The level of controls should be commensurate to their use and to the available stability data.”
-
Question 13 of 14
13. Question
Written contracts covering outsourced activities should contain technical details in addition to commercial aspects.
Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 7 Outsourced activities, 7.1, page 40
“There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.”
Incorrect
Incorrect. Refer to: PE 009-13, Part I, Chapter 7 Outsourced activities, 7.1, page 40
“There should be a written contract covering the outsourced activities, the products or operations to which they are related, and any technical arrangements made in connection with it.”
-
Question 14 of 14
14. Question
Self inspections should be conducted into the following areas:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-13, Part I, Chapter 9 Self inspection, 9.1, page 45
“Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.”
Incorrect
Incorrect. Refer to: PE 009-13, Part I, Chapter 9 Self inspection, 9.1, page 45
“Personnel matters, premises, equipment, documentation, production, quality control, distribution of the medicinal products, arrangements for dealing with complaints and recalls, and self inspection, should be examined at intervals following a pre-arranged programme in order to verify their conformity with the principles of Quality Assurance.”
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Test your GMP knowledge with the 2016 GMP quiz. There are 14 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 14
1. Question
Self inspections should be conducted in order to:
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 9 Self Inspection, Principle section, page 43.
“Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.”
Incorrect
Sorry, that’s the wrong answer. Refer to PE 009-12, Part I, Chapter 9 Self Inspection, Principle section, page 43.
“Self inspections should be conducted in order to monitor the implementation and compliance with Good Manufacturing Practice principles and to propose necessary corrective measures.”
-
Question 2 of 14
2. Question
The heads of Production and Quality Control should not be independent from each other
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 2 Personnel- Key Personnel, 2.3, page 7.
“Key Personnel includes the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorised person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other.”
Incorrect
False. Refer to PE 009-12, Part I, Chapter 2 Personnel- Key Personnel, 2.3, page 7.
“Key Personnel includes the head of Production, the head of Quality Control, and if at least one of these persons is not responsible for the release of products the authorised person(s) designated for the purpose. Normally key posts should be occupied by full-time personnel. The heads of Production and Quality Control must be independent from each other.”
-
Question 3 of 14
3. Question
The quality risk management (QRM) system should ensure that:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 1 Quality Management- Quality Risk Management, 1.6, page 5.
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 1 Quality Management- Quality Risk Management, 1.6, page 5.
-
Question 4 of 14
4. Question
Visitors or untrained personnel, if taken into the production or Quality Control areas, should be given information in advance about personal hygiene and the prescribed protective clothing and be closely supervised.
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 2, Personnel- Training, 2.11, page 9
“Visitors or untrained personnel should, preferably, not be taken into the production and Quality Control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 2, Personnel- Training, 2.11, page 9
“Visitors or untrained personnel should, preferably, not be taken into the production and Quality Control areas. If this is unavoidable, they should be given information in advance, particularly about personal hygiene and the prescribed protective clothing. They should be closely supervised.”
-
Question 5 of 14
5. Question
Only manufacturing personnel entering the manufacturing areas need to wear protective garments appropriate to the operations carried out in the area
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 2 Personnel- Personnel Hygiene, 2.16, page 10
“Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 2 Personnel- Personnel Hygiene, 2.16, page 10
“Every person entering the manufacturing areas should wear protective garments appropriate to the operations to be carried out.”
-
Question 6 of 14
6. Question
Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 3 Premises and Equipment- General, 3.5, page 11
“Steps should be taken in order to prevent the entry of unauthorised people. Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 3 Premises and Equipment- General, 3.5, page 11
“Steps should be taken in order to prevent the entry of unauthorised people. Production, storage and quality control areas should not be used as a right of way by personnel who do not work in them.”
-
Question 7 of 14
7. Question
Any alteration to the entry on a document should:
(select all applicable statements)Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 4 Documentation- Good Documentation Practices, 4.9, page 17
“Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 4 Documentation- Good Documentation Practices, 4.9, page 17
“Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.”
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Question 8 of 14
8. Question
There should be appropriately authorised and dated specifications for starting and packaging materials, and finished products
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 4 Documentation- Specifications, 4.13, page 18
“There should be appropriately authorised and dated specifications for starting and packaging materials, and finished products.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 4 Documentation- Specifications, 4.13, page 18
“There should be appropriately authorised and dated specifications for starting and packaging materials, and finished products.”
-
Question 9 of 14
9. Question
Records should be maintained for the distribution of every batch of product in order to facilitate recall of any batch, if necessary
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 4 Documentation – Procedures and Records, 4.28, page 23
“Records should be maintained for the distribution of each batch of a product in order to facilitate recall of any batch, if necessary.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 4 Documentation – Procedures and Records, 4.28, page 23
“Records should be maintained for the distribution of each batch of a product in order to facilitate recall of any batch, if necessary.”
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Question 10 of 14
10. Question
At some stages of processing, products and materials should be protected from microbial and other contamination.
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 5 Production- General, 5.10, page 25
“At every stage of processing, products and materials should be protected from microbial and other contamination.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 5 Production- General, 5.10, page 25
“At every stage of processing, products and materials should be protected from microbial and other contamination.”
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Question 11 of 14
11. Question
Measures to prevent cross-contamination and their effectiveness should be checked periodically according to set procedures.
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 5 Production- Prevention of Cross-Contamination in Production, 5.20, page 27
“Measures to prevent cross-contamination and their effectiveness should be checked periodically according to set procedures.”
Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 5 Production- Prevention of Cross-Contamination in Production, 5.20, page 27
“Measures to prevent cross-contamination and their effectiveness should be checked periodically according to set procedures.”
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Question 12 of 14
12. Question
Starting material labels should include at least the following information
(select all applicable statements)
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 5 Production- Starting Materials, 5.29, page 28
“Labels should bear at least the following information:
the designated name of the product and the internal code reference where applicable;
a batch number given at receipt;
where appropriate, the status of the contents (e.g. in quarantine, on test, released, rejected);
where appropriate, an expiry date or a date beyond which retesting is necessary.
When fully computerised storage systems are used, all the above information should not necessarily be in a legible form on the label.”Incorrect
Incorrect. Refer to PE 009-12, Part I, Chapter 5 Production- Starting Materials, 5.29, page 28
“Labels should bear at least the following information:
the designated name of the product and the internal code reference where applicable;
a batch number given at receipt;
where appropriate, the status of the contents (e.g. in quarantine, on test, released, rejected);
where appropriate, an expiry date or a date beyond which retesting is necessary.
When fully computerised storage systems are used, all the above information should not necessarily be in a legible form on the label.” -
Question 13 of 14
13. Question
An out of specification or significant atypical trend in an on-going stability program:
(select all applicable statements)
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 6 Quality Control- On-going stability programme, 6.32, page 37
“Out of specification or significant atypical trends should be investigated. Any confirmed out of specification result, or significant negative trend, should be reported to the relevant competent authorities. The possible impact on batches on the market should be considered in accordance with chapter 8 of the GMP Guide and in consultation with the relevant competent authorities.”
Incorrect
Incorrect. Refer to: PE 009-12, Part I, Chapter 6 Quality Control- On-going stability programme, 6.32, page 37
“Out of specification or significant atypical trends should be investigated. Any confirmed out of specification result, or significant negative trend, should be reported to the relevant competent authorities. The possible impact on batches on the market should be considered in accordance with chapter 8 of the GMP Guide and in consultation with the relevant competent authorities.”
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Question 14 of 14
14. Question
Storage areas should:
(select all applicable statements)
Correct
Correct! The GMP reference is PE 009-12, Part I, Chapter 3 Premises and equipment- Storage Areas, 3.18-3.20, page 13
“3.18 – Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recalled.
3.19 – Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.
3.20 – Receiving and dispatch bays should protect materials and products from the weather. Receptions areas should be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage.”Incorrect
Incorrect. Refer to: PE 009-12, Part I, Chapter 3 Premises and equipment- Storage Areas, 3.18-3.20, page 13
“3.18 – Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials, intermediate, bulk and finished products, products in quarantine, released, rejected, returned or recalled.
3.19 – Storage areas should be designed or adapted to ensure good storage conditions. In particular, they should be clean and dry and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.
3.20 – Receiving and dispatch bays should protect materials and products from the weather. Receptions areas should be designed and equipped to allow containers of incoming materials to be cleaned where necessary before storage.”
Leaderboard: GMP Quiz 2016
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