Clean Room and GMP Quiz

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;”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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:

1. 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;
2. b) Providing appropriate air-locks and air extraction;
3. c) Minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
4. d) Keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
5. e) Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
6. f) Using “closed systems” of production;

g) Testing for residues and use of cleaning status labels on equipment.”

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.”

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.”

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.”

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;”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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:

1. 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;
2. b) Providing appropriate air-locks and air extraction;
3. c) Minimising the risk of contamination caused by recirculation or re-entry of untreated or insufficiently treated air;
4. d) Keeping protective clothing inside areas where products with special risk of cross-contamination are processed;
5. e) Using cleaning and decontamination procedures of known effectiveness, as ineffective cleaning of equipment is a common source of cross-contamination;
6. f) Using “closed systems” of production;

g) Testing for residues and use of cleaning status labels on equipment.”

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.”

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.”

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.”