Conducting an Inspection
Additionally, there are multiple systems within the manufacturing process that are usually reviewed during an inspection. There are six systems: quality system, facilities and equipment system, materials system, production system, packaging and labeling system and the laboratory control system. Definitions for these can be found in the Compliance Program Guidance Manual (CPGM) No. 7356002, Drug Manufacturing Inspections.
The quality system has a link to each of the other five systems. As part of the quality system, there are annual product reviews. The annual product review provides information on a product for an entire year showing complaints, the number of deviations (from the process system or product control) and the subsequent number of rejected batches. Records of this type of information provide a feel for the kind of control that was maintained in manufacturing a specific product during that period and help direct which of the five other systems should be a focus during the inspection.
