Finally published: new EU GMP Chapter 7 on Outsourced Activities
Chapter 7 of the EU GMP Guide "Contract Manufacture and Analysis" has also been revised, and the Directorate-General for Health and Consumers (DG SANCO) of the European Commission recently published the final version. The deadline for coming into operation is 31 January 2013!
The reason given for this change was, "to provide updated guidance on outsourced GMP regulated activities beyond the current scope of contract manufacture and analysis operations", also with respect to the ICH Q10 guideline on the Pharmaceutical Quality System. Consequently, the title of the chapter as well as all homonymic parts in the text have been changed from "Contract Manufacture and Analysis" to "Outsourcing Activities".
The most important amendments in the provisions of the revised Chapter 7 are summarised here:
For the Contract Giver:
The control and review of any outsourced activities is an essential part of the quality system. The Contract Giver is "ultimately responsible" for ensuring that processes to assure control of the outsourced activities are in place. These "processes should incorporate quality risk management principles".
Prior to outsourcing activities, the Contract Giver is responsible for carrying out a comprehensive assessment of the Contract Acceptor with respect to "legality, suitability and the competence of the Contract Acceptor".
The Contract Giver has to carry out continuous reviews of the quality of the Contract Acceptor's performance, including "identification and implementation of any needed improvement".
The Contract Giver is also responsible that all records and results are being reviewed and "that all products and materials delivered to him by the Contract Acceptor have been processed in accordance with GMP and the marketing authorisation". This can also be confirmed by the Qualified Person (QP) of the Contract Acceptor.
For the Contract Acceptor:
When subcontracting, it must be ensured that all necessary 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 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, testing and releasing materials, undertaking production and quality controls".
The contract should permit the Contract Giver to audit the Contract Acceptor and his subcontractors.
The changes introduced in the revision of Chapter 7 are obviously designed to intensify the control of Contract Acceptors by the Contract Giver and extend those controls to subcontractors.
For ECA members, we have created a document comparison contrasting the requirements of the current version of Chapter 7 with the new requirements. In this document, you can see exactly where changes and deletions have been made. The document comparison can be found in the ECA Members' Area.
The European Compliance Academy ECA intends to support the pharmaceutical industry in understanding and implementing the revised approach and legal framework in this respect. Therefore ECA has been setting up several course and conferences:
In the Course on Pharmaceutical Contracts (19/20 March 2013 in Berlin) you will get to know possibilities and tools to realise compliant contracts which can be deployed in your daily work.
During the course on Integrated and Efficient Supplier Qualification (11 - 12 April 2013), Budapest, you will learn all relevant aspects to implement and/ or improve a comprehensive and integrated Supplier Qualification System which fulfils regulatory GMP requirements.
Wolfgang Schmitt CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)