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Chapter 7 of EU GMP Guide “Contract Manufacture and Analysis” revised

Chapter 7 “Contract Manufacture and Analysis” will be re-titled as “Outsourced Activities” from the 31st of January 2013. The revision will provide further clarification and guidance on “any activity covered by the GMP guide that is outsourced”, rather than just “contract manufacture and analysis”, as per the previous version. This update also aligns the context of this Chapter with the principles in ICH Q10 Pharmaceutical Quality System.

The Contract Giver section of the document specifies that the Contract Givers internal Pharmaceutical Quality System should include the “control and review of outsourced activities” and that they are “ultimately responsible to ensure processes are in place to assure the control of outsourced activities”. These processes should “incorporate quality risk management principles” and before outsourcing activities commence, the Contract Giver is responsible for “assessing the legality, suitability and competence” of the Contract Acceptor, as well as ensuring that the GMP Guide is followed. The Contract Giver also should provide the “information and knowledge necessary” to ensure that the Contract Acceptor can “carry out the contracted operations correctly” and are aware of problems with the work which might pose a hazard. The Contract Giver must “monitor and review the performance” of the contracted operations and are responsible for reviewing and assessing the results related to the outsourced activities, ensuring GMP compliance.

The Contract Acceptor section details that the Contract Acceptor “must be able to carry out satisfactorily the work ordered by the Contract Giver” and that all supplied “products, materials and knowledge” are suitable for their intended purpose. The Contract Acceptor should not subcontract to a third party without prior evaluation and agreement, and not “make unauthorised changes” that may impact the quality of the outsourced activity.

The written Contract agreement itself should contain information including responsibilities of both parties, communication processes and technical details such as “knowledge management, technology transfer, supply chain, subcontracting, control of materials and undertaking production and quality controls”. The Contract should also “permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed subcontractors”.

The document is available here.

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