ABSTRACT
The Food and Drug Administration has developed two basic strategies. These are evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, tested, and held and monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution. The Drug Product Surveillance Program provides guidance for the latter strategy. Drugs and drug products are manufactured using many physical operations to bring together components, containers, and closures into a product that is released for distribution. Inspections of drug manufacturers should be made and reported using the system definitions and organization in this compliance program. The District drug program managers should ensure that the optional systems are rotated in successive abbreviated inspections. A firm in a state of control produces finished drug products for which there is an adequate level of assurance of quality, strength, identity, and purity.
