Clean Room and GMP Quiz

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.”

MP 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:

1. 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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”

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.”