Chapter 7 of EC GMP Guide to be revised

Chapter 7 of the EC GMP Guide describes the requirements for Contract Manufacture and Analysis. "Contract manufacture and analysis must be correctly defined, agreed and controlled". In addition to the responsibilities of the contract giver and contract acceptor chapter 7 also specifies the contract preparation, especially relative to the scope of responsibilities. What is still missing yet gaining more actuality, are outsourcing activities wich are not directly linked to contract manufacture or contract analysis. These are for instance

  • Maintenance, qualification and validation activities
  • Storage and transport
  • Label printing
  • Release activities (e.g. by external QPs) and
  • GMP audits by third parties

In these cases industry as well as inspectors are sometimes lacking the clarity whether or not chapter 7 can be applied and whether they are part of a GMP inspection. Also, the chapter does not consider modern approaches as e.g. described in ICH Q 10.

The European Medicines Agency's (EMEA) GMP/GDP Inspectors Working Group (GMDP IWG) now agreed to a Concept Paper proposing a revision. The revision of chapter 7 is supposed to be initiated after a check for actuality. A first proposal is to be worked out during the meeting of the GMDP IWG in May 2010. The draft of the new guideline is planned for September 2010 - with the goal to submit it to the European Commission in September 2011.

We will keep you posted.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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