Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 7: Control of customer supplied productPrincipleCustomer supplied product is raw material, intermediate, product component etc. owned bythe customer, for which the API manufacturer is temporarily responsible by virtue ofperforming a processing activity. Management control over the quality of customer suppliedproduct should be included in the scope of the API manufacturers quality system. In particular,instances of damage, or otherwise adverse findings, should be recorded and reported to thecustomer without delay.7.1 There should be a written and approved contract between the contract giver and thecontract acceptor, which lays down the responsibilities of each party.7.2 Items provided by the customer should be clearly identifiable.7.3 Items provided by the customer should have their quality verified by inspectionand/or testing, and subsequently handled in such a way as to prevent deterioration,damage or loss.7.4 Items provided by the customer should be stored under appropriate conditions toavoid deterioration or damage.7.5 Damage to, or otherwise adverse findings associated with, customer suppliedproduct should be notified to the customer without delay.26