EU-GMP Chapter 7: Is a "Chain of Contracts" allowed?

The European Medicine Agency EMA has updated its Questions and Answers and discusses the "Chain of Contracts", a "setup where one or more parties (sites/companies) are acting as signatory in a chain of contracts that links them together. Thus, the setup introduces one or several separate legal entities between the contract giver - e.g. a MIA holder responsible for QP certification and the contract manufacturer as a contract acceptor. In fact, the GMP activities concerned are sub-contracted over one or several levels".

The answer clarifies in which exceptional cases such a set-up would be acceptable instead of direct written contracts, for example:

  • Robust and timely communication between the MAH, the MIA holder responsible for QP certification and the contract manufacturers is secured.
  • The MIA holder and the QP should have access to all of the contracts in the "chain of contracts". Contract manufacturers should have access to those contracts relevant to the activities they perform.
  • The MIA holder and the QP should perform a written assessment of the suitability and functionality of such a setup.
  • Changes are notified to and accepted by the MIA holder and the QP prior to the change of the respective contracts.
  • All parties in a "chain of contracts" setup should be audited and evaluated according EU-GMP Chapter 7 and Annex 16 and reflected in the supply chain diagram.
  • All contracts in a "chain of contracts" setup are reviewed as part of the product quality review (PQR) process.

However, "direct written contracts" are still preferred: These are contracts "signed between the parties, that actually perform the activities stated in the contract", e.g. MAH as a contract giver and the MIA holder responsible for QP certification as a contract acceptor or the MIA holder responsible for QP certification as a contract giver and contract manufacturers."

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