The Systems Approach
Compliance Program Guidance (CPG) Manual No. 7356002, Drug Manufacturing Inspections, is where the definitions for the systems approach can be found. There are 6 systems: quality system, facilities and equipment system, materials system, production system, packaging and labeling system and the laboratory control system.
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 and the number of rejected batches. If there is a record of that information, it provides a feel for what kind of control is had over a specific product. More than likely, a company will trend some data providing a snapshot of the year.
