ABSTRACT
The US Food and Drug Administration (FDA) has updated a program in its Compliance Program Guidance Manual chapter on Drug Quality Assurance, entitled Active Pharmaceutical Ingredient (API) Process Inspection (Compliance Program). The Compliance Program defines FDA's systems-based approach for the conduct of API inspections, which has been customized to evaluate API processes rather than drug product processes. FDA considers the inspection of the Quality System and the other selected systems to be applicable to each API product using the system and encourages inspectors to select a sufficient number and type of APIs to adequately review the system’s coverage. The selected APIs are intended and expected to be representative of the firm’s overall current good manufacturing practice capabilities. Under the Compliance Program, an inspector is instructed to review and assess specified written and approved procedures and corresponding documentation resulting from implementation of the specified procedures that characterize an API manufacturer’s Quality System.
