Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISOChapter 12: Inspection and test statusPrincipleIt should be possible to readily identify, at all stages from design through manufacture todelivery to the customer, if a product has ‘pass’ or ‘fail’ status, or if it is waiting to be tested.12.1 The identification of material/intermediate/product quality status should bemaintained throughout the various manufacturing, storage, delivery stages to ensurethat only passed material (or material under conditional status) is used. Onlysatisfactory product should be supplied to the customer.12.2 The means of identifying inspection and test status may vary depending oncircumstances. For example, in stores and warehouses it may be possible to uselabels, while in production environments colour-coded bins may provide thedistinction between passed versus rejected material. Computer tracking can also beacceptable. Whichever approach is taken, it should be capable of quickly and clearlyallowing identification of inspection and test status.12.3 Inspection and test procedures should be written and approved by the QualityFunction and should define who has responsibility for determining inspection andtest status during processing stages and at final release.40