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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 15 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?
Correct
Version 13 of the PIC/s PE-009 Guide to Good Manufacturing Practice was adopted by the TGA from 01st January 2019. This replaced Version 8 of PE-009 that had been adopted in 2010.
Incorrect
Version 13 of the PIC/s PE-009 Guide to Good Manufacturing Practice was adopted by the TGA from 01st January 2019. This replaced Version 8 of PE-009 that had been adopted in 2010.
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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?
Correct
The GMP reference is PE-009-13 Chapter 1 Pharmaceutical Quality System, Clause 1.3 “The size and complexity of the company’s activities should be taken into consideration when developing a new Pharmaceutical Quality System or modifying an existing one. The design of the system should incorporate appropriate risk management principles including the use of appropriate tools. While some aspects of the system can be company-wide and others site-specific, the effectiveness of the system is normally demonstrated at the site level.”
Incorrect
The GMP reference is PE-009-13 Chapter 1 Pharmaceutical Quality System, Clause 1.3 “The size and complexity of the company’s activities should be taken into consideration when developing a new Pharmaceutical Quality System or modifying an existing one. The design of the system should incorporate appropriate risk management principles including the use of appropriate tools. While some aspects of the system can be company-wide and others site-specific, the effectiveness of the system is normally demonstrated at the site level.”
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Question 3 of 15
3. Question
Quality Risk Management can be applied retrospectively as well as proactively.
Correct
The GMP reference is PE-009-13 Part 1 Chapter 1 Pharmaceutical Quality System, Clause 1.12 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.”
Incorrect
The GMP reference is PE-009-13 Part 1 Chapter 1 Pharmaceutical Quality System, Clause 1.12 “Quality Risk Management is a systematic process for the assessment, control, communication and review of risks to the quality of the medicinal product. It can be applied both proactively and retrospectively.”
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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?
Correct
The GMP reference is PE-009-13 Part 1 Chapter 2: Personnel, Clause 2.4 “Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality and should ensure continuing suitability and effectiveness of the Pharmaceutical Quality System and GMP compliance through participation in management review.”
Incorrect
The GMP reference is PE-009-13 Part 1 Chapter 2: Personnel, Clause 2.4 “Senior management has the ultimate responsibility to ensure an effective Pharmaceutical Quality System is in place to achieve the quality objectives, and, that roles, responsibilities, and authorities are defined, communicated and implemented throughout the organisation. Senior management should establish a quality policy that describes the overall intentions and direction of the company related to quality and should ensure continuing suitability and effectiveness of the Pharmaceutical Quality System and GMP compliance through participation in management review.”
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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.
Correct
The GMP clause is PE009-013 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.”
Incorrect
The GMP clause is PE009-013 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 6 of 15
6. Question
Where would I find specific requirements for the manufacturer of special groups of products? e.g. Sterile Preparations
Correct
The GMP clause is PE009-13 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.”
The Annexes cover specific requirements for different manufacturing processes, for example:
Annex 1: Manufacture of Sterile Medicinal Products
Annex 2: Manufacture of Biological medicinal substances and Products
Annex 3: Manufacture of radiopharmaceuticals
Annex 6: Manufacture of Medicinal GasesIncorrect
The GMP clause is PE009-13 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.”
The Annexes cover specific requirements for different manufacturing processes, for example:
Annex 1: Manufacture of Sterile Medicinal Products
Annex 2: Manufacture of Biological medicinal substances and Products
Annex 3: Manufacture of radiopharmaceuticals
Annex 6: Manufacture of Medicinal Gases -
Question 7 of 15
7. Question
Rejected, Returned or Recalled product can be stored with finished product once it is correctly labelled?
Correct
The GMP Clause is PE-009-13 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
The GMP Clause is PE-009-13 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.”
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Question 8 of 15
8. Question
What information should be clearly displayed on fixed pipework?
Correct
The GMP clause is PE009-013 Part 1, Chapter 3: Premises and Equipment, Clause 3.42 “Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow”
Incorrect
The GMP clause is PE009-013 Part 1, Chapter 3: Premises and Equipment, Clause 3.42 “Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow”
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Question 9 of 15
9. Question
How long should batch documentation be kept for Investigation Medicinal Products (IMPs)?
Correct
The GMP clause is PE-009-013 part 1, 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.”
Incorrect
The GMP clause is PE-009-013 part 1, 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 10 of 15
10. Question
An independent secondary verification should be performed for each dispensed material, as well as weight and volume checks
Correct
The GMP Clause is PE009-013 Part 1, Chapter 5: Production, Clause 5.33 “Each dispensed material and its weight or volume should be independently checked and the check recorded.”
Incorrect
The GMP Clause is PE009-013 Part 1, Chapter 5: Production, Clause 5.33 “Each dispensed material and its weight or volume should be independently checked and the check recorded.”
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Question 11 of 15
11. Question
When setting up packaging operations, particular attention should be given to the following:
Correct
The GMP clause is PE-009-013 Part 1, Chapter 5: Production, Clause 5.44 “When setting up a programme for the packaging operations, particular attention should be given to minimising the risk of cross-contamination, mix-ups or substitutions. Different products should not be packaged in close proximity unless there is physical segregation.”
Incorrect
The GMP clause is PE-009-013 Part 1, Chapter 5: Production, Clause 5.44 “When setting up a programme for the packaging operations, particular attention should be given to minimising the risk of cross-contamination, mix-ups or substitutions. Different products should not be packaged in close proximity unless there is physical segregation.”
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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?
Correct
The correct GMP clause is PE009-013 Chapter 5: Production, clause 5.57 “. Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed and the destruction recorded. A documented procedure should be followed if uncoded printed materials are returned to stock.”
Incorrect
The correct GMP clause is PE009-013 Chapter 5: Production, clause 5.57 “. Upon completion of a packaging operation, any unused batch-coded packaging materials should be destroyed and the destruction recorded. A documented procedure should be followed if uncoded printed materials are returned to stock.”
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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?
Correct
The correct GMP clause is PE009-013, chapter 7: Outsourced Activities, clause 7.7 “The Contract Acceptor should ensure that all products, materials and knowledge delivered to him/her are suitable for their intended purpose.”
Incorrect
The correct GMP clause is PE009-013, chapter 7: Outsourced Activities, clause 7.7 “The Contract Acceptor should ensure that all products, materials and knowledge delivered to him/her 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?
Correct
The GMP Clause is PE009-013, Chapter 8: Complaints and Recalls, Clause 8.8 “The Competent Authorities should be informed if a manufacturer is considering action following possibly faulty manufacture, product deterioration, detection of counterfeiting or any other serious quality problems with a product”
Incorrect
The GMP Clause is PE009-013, Chapter 8: Complaints and Recalls, Clause 8.8 “The Competent Authorities should be informed if a manufacturer is considering action following possibly faulty manufacture, product deterioration, detection of counterfeiting or any other serious quality problems with a product”
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Question 15 of 15
15. Question
Recall processes should be able to be implemented at least once a year?
Correct
The GMP clause is PE009-013, Chapter 8: Complaints and Product Recall, clause 8.11: “Recall operations should be capable of being initiated promptly and at any time”
Incorrect
The GMP clause is PE009-013, Chapter 8: Complaints and Product Recall, clause 8.11: “Recall operations should be capable of being initiated promptly and at any time”
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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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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.”
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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.”
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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.”
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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.”
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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.”
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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.”
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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.”
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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.
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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.”
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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.”
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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.”
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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.”
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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.”
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Cleanroom Quiz 2017
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Test your GMP knowledge of cleanroom design by taking the GMP cleanroom quiz. The quiz will take you through the engineering considerations which are fundamental to good cleanroom design. There are 19 multiple choice questions and the quiz will take about 5 minutes.
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Question 1 of 24
1. Question
A GMP clean room requires a minimum air change rate of 20 air changes per hour
Correct
The number of air changes will depend on the room classification and the level of activity conducted within the room. Guidance figures of a room recovery within 10-15 minutes are provided in PE009-12 Annex 1.
Incorrect
The number of air changes will depend on the room classification and the level of activity conducted within the room. Guidance figures of a room recovery within 10-15 minutes are provided in PE009-12 Annex 1.
Hint
PIC/S PE009-12 Annex 1 Section 14
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Question 2 of 24
2. Question
In designing a clean room, GMP requirements always override health, safety and environmental requirements
Correct
Clean rooms still need to meet relevant local health, safety and environmental regulations
Incorrect
Clean rooms still need to meet relevant local health, safety and environmental regulations
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Question 3 of 24
3. Question
Personnel always need to wear gloves in Grade D clean rooms which provide support activities to aseptic (sterile) manufacturing operations
Correct
PIC/S PE009-12 makes no reference to the use of gloves in a Grade C or D area, however for Grade A/B: Appropriate sterilised, non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibres or particulate matter and retain particles shed by the body.
Incorrect
PIC/S PE009-12 makes no reference to the use of gloves in a Grade C or D area, however for Grade A/B: Appropriate sterilised, non-powdered rubber or plastic gloves and sterilised or disinfected footwear should be worn. Trouser-legs should be tucked inside the footwear and garment sleeves into the gloves. The protective clothing should shed virtually no fibres or particulate matter and retain particles shed by the body.
Hint
Refer to PIC/S PE009-12 Annex 1, Section 43
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Question 4 of 24
4. Question
Polystyrene sandwich panels are still the best clean room construction material
Correct
You should be concerned about the fire rating problems with EPS. More fire resistant materials including polyisocyanourate (PIR) are available on the market. We recommend discussing with a specialist or your insurer.
Incorrect
You should be concerned about the fire rating problems with EPS. More fire resistant materials including polyisocyanourate (PIR) are available on the market. We recommend discussing with a specialist or your insurer.
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Question 5 of 24
5. Question
PIC/S GMP provides a guidance value of 10-15 Pascals pressure differential
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 53
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Question 6 of 24
6. Question
Blow fill seal equipment used for the production of products which are terminally sterilised should be installed in a clean room environment of at least:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 26
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Question 7 of 24
7. Question
Isolator technology for aseptic processing should be installed in a clean room with a background environment of at least:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 23
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Question 8 of 24
8. Question
Filling operations for terminally sterilised products should be carried out in at least:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 29
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Question 9 of 24
9. Question
For aseptic preparations that require freeze drying, the transfer of fully stoppered vials post freeze drying and prior to capping should be done in:
Correct
Incorrect
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Question 10 of 24
10. Question
For aseptic preparation that requires freeze drying, transfer of partially closed containers prior to stoppering where sealed transfer trays are used should be done in:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 34
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Question 11 of 24
11. Question
Sinks and drains are allowed in grade A / B areas used for aseptic manufacture
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 50
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Question 12 of 24
12. Question
Both doors in an air lock should:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 52
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Question 13 of 24
13. Question
According to PIC/S PE009-12 Annex 1, false ceilings are prohibited in a clean room
Correct
PIC/S PE009-12 Annex 1 Section 48 “False ceilings should be sealed to prevent contamination from the space above them”
Incorrect
PIC/S PE009-12 Annex 1 Section 48 “False ceilings should be sealed to prevent contamination from the space above them”
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Question 14 of 24
14. Question
Indicators of pressure differences should be fitted between areas:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 55
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Question 15 of 24
15. Question
Outdoor clothing should not be brought into:
Correct
Incorrect
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Question 16 of 24
16. Question
According to PIC/S GMP Annex 1, sliding doors may be undesirable in clean rooms because they:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 Section 47
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Question 17 of 24
17. Question
Particle monitoring of clean areas “in operation” should be performed for:
Correct
Incorrect
Hint
PIC/S PE009-12 Annex 1 sections 9, 10 and 15
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Question 18 of 24
18. Question
Particle limits for Grade D “at rest” is equivalent to ISO 8
Correct
Limits are:
3,520,000 particles/m3 @ 0.5 micron
29,000 particles/m3 @ 5.0 micron
Incorrect
Limits are:
3,520,000 particles/m3 @ 0.5 micron
29,000 particles/m3 @ 5.0 micron
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Question 19 of 24
19. Question
Cleanroom Total Particulate Count measurement “At rest” requires:
Correct
Incorrect
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Question 20 of 24
20. Question
Services installations and fittings (e.g. pipeworks, light fittings and ventilation points) shall be designed and located to avoid the creation of recesses which are difficult to clean
Correct
Clause 3.10 Chapter 3 PIC/S PE009-12 (Part I)
Incorrect
Clause 3.10 Chapter 3 PIC/S PE009-12 (Part I)
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Question 21 of 24
21. Question
If additional lighting is required in the cleanroom during operation, the operators can install new pendant or wall mounted light fittings
Correct
PIC/S PE009-12 (Part I) Chapter 3 Clause 3.10
Incorrect
PIC/S PE009-12 (Part I) Chapter 3 Clause 3.10
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Question 22 of 24
22. Question
Which of the following statement(s) is/ are correct?
Correct
PIC/S PE009-12 (Parts I and II)
Incorrect
PIC/S PE009-12 (Parts I and II)
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Question 23 of 24
23. Question
Cleanrooms are measured for particulate counts at three different states: “as-built”, “at rest” and “in-operation”
Correct
Incorrect
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Question 24 of 24
24. Question
To minimise changes during construction, various types of feasible electrical power supplies, for example authority mains supply, backup generator and critical power system, should be discussed and finalised with the end users during the detailed design stage.
Correct
AS/ISO 14644.4:2002
Incorrect
AS/ISO 14644.4:2002
Leaderboard: Cleanroom Quiz 2017
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Safety & GMP Playing Cards
If you have battled, like us, to communicate the GMP message and try make a difference at the shop floor you might find these cards helpful, they were a hit at a recent conference.
These engaging playing cards contain information that that relate to PIC/S, United States (US) and European (EU) regulatory codes, so they are applicable to most countries.
Safety packet contains 54 cards made up of 48x safety quiz playing cards, be warned they are a bit corny, 4x reference cards and 2x joker cards.
Each packet contains 54 cards made up of 48x GMP quiz playing cards, 4x reference cards and 2x joker cards.