Chapter 7 of the EU GMP Guide “Contract Manufacture and Analysis” has been revised and was published on the GMP-information site of the European Commission on 9 November 2010. The reason given for this change was, that the provisions of Chapter 7 are to be harmonised with the requirements of ICH Q10 (Pharmaceutical Quality Systems). For this purpose, the scope of the chapter had to be extended beyond mere contract manufacture and analysis so that further, outsourced activities are also covered by Chapter 7. Consequently, the title of the chapter as well as all homonymic passages in the text, have been changed from “Contract Manufacture and Analysis” to “Outsourcing Activities”.
The most important changes in the provisions of the revised Chapter 7 are listed below:
[b][COLOR=“darkred”]For the Contract Giver:
The control and review of any outsourced activities must be part of the quality system and the responsibility of management. The Contract Giver is ultimately responsible for ensuring that processes to assure control are in place. These processes should incorporate quality risk management.
Prior to outsourcing activities, the Contract Giver is responsible for carrying out a comprehensive assessment of the Contract Acceptor as concerns his GMP competency (e.g. audits). In particular, the Contract Giver must satisfy himself of the GMP competency of further subcontractors of the Contract Acceptor as well as of the supply chain’s GMP conformity.
The Contract Giver is also responsible for carrying out continuous and documented control of the quality of the Contract Acceptors performance. This also comprises the identification and implementation of any needed improvement.
For the Contract Acceptor:
It must be ensured that all needed information, including that from assessments of the suitability of the subcontractor is available in the same way as between the original Contract Giver and Contract Acceptor.
The Contract Acceptor should not introduce unauthorised changes, which may adversely affect the quality of the activities outsourced by the Contract Giver.
For the Contract:
The responsibilities as well as the communication processes relating to the outsourced activities have to be defined.
The contract should clearly describe who is responsible for each step of the outsourced activity, e.g. knowledge management, technology transfer, supply chain, subcontracting, quality and purchasing of materials, sampling and analysis within the context of quality control.
All records related to the outsourced activities should be kept by, or be available to, the Contract Giver.
The contract should permit the Contract Giver to audit the Contract Acceptor or his subcontractors.[/color][/b]
The changes introduced in the revision of Chapter 7 are obviously designed to intensify the control of Contract Acceptors by the Contract Giver. The opinions will reflect whether these new and far-reaching requirements of Chapter 7 are useful, feasible and desired by pharmaceutical firms and contract manufacturers.