chapter  2
12 Pages

Biennial Inspection of Manufacturing Sites

A primary mission of the Food and Drug Administration (FDA) is to conduct comprehensive regulatory coverage of all aspects of production and distribution of drugs and drug products to assure that such products meet the 501(a)(2)(B) requirements of the Food, Drugs and Cosmetics Act. The FDA has developed two basic strategies:

1. Evaluating through factory inspections, including the collection and analysis of associated samples, the conditions and practices under which drugs and drug products are manufactured, packed, tested, and held

2. Monitoring the quality of drugs and drug products through surveillance activities such as sampling and analyzing products in distribution

This compliance program is designed to provide guidance for implementing the first strategy. Products from production and distribution facilities covered under this program are consistently of acceptable quality if the firm is operating in a state of control. The Drug Product Surveillance Program (CP 7356.008) provides guidance for the latter strategy.