16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)

16. CONTRACT MANUFACTURERS (INCLUDING LABORATORIES)
16.10 All contract manufacturers (including laboratories) should comply with the GMP defined in this Guide. Special consideration should be given to the prevention of cross-contamination and to maintaining traceability.
16.11 Contract manufacturers (including laboratories) should be evaluated by the contract giver to ensure GMP compliance of the specific operations occurring at the contract sites.
16.12 There should be a written and approved contract or formal agreement between the contract giver and the contract acceptor that defines in detail the GMP responsibilities, including the quality measures, of each party.
16.13 The contract should permit the contract giver to audit the contract acceptor's facilities for compliance with GMP.
16.14 Where subcontracting is allowed, the contract acceptor should not pass to a third party any of the work entrusted to him under the contract without the contract giver's prior evaluation and approval of the arrangements.
16.15 Manufacturing and laboratory records should be kept at the site where the activity occurs and be readily available.
16.16 Changes in the process, equipment, test methods, specifications, or other contractual requirements should not be made unless the contract giver is informed and approves the changes.