ICH Q7 - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients 16: Evaluate contract manufacturers and laboratories for GMP, set written GMP responsibilities with audit rights, control subcontracting and changes, and keep records at the contract site

What does 16 require?

Contract manufacturers and contract laboratories should meet this GMP, with special attention to preventing cross-contamination and keeping traceability. The contract giver should evaluate them to confirm that the particular operations done at the contract site meet GMP. A written, approved contract or formal agreement should define in detail each party's GMP responsibilities including quality measures, and should allow the contract giver to audit the acceptor's facilities. Where subcontracting is allowed, the acceptor should not pass any of the work to a third party without the giver's prior evaluation and approval. Manufacturing and laboratory records should stay at the site where the work is done and be readily available. No change to process, equipment, specifications, test methods or other contract terms should be made without informing the giver and getting its approval.