In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy. This guidance applies to the commercial manufacturing of Active Pharmaceutical Ingredients (APIs or drug substances, or their intermediates), finished drug products, combination products, and biological drug products. For the purposes of this guidance, the term “manufacturing” includes processing, packing, holding, labeling operations, testing, and operations of the Quality Unit.

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Biotechnology Inspection Guide

This Guide was initiated by Robert C. Fish, Director, Division of Field Investigations (DFI). Mr. Fish asked Barbara-Helene mith, Ph.D., DIB, CHI-DO, to chair a workgroup to develop inspectional guidelines for Investigators in the area of biotechnology. The workgroup, which also included Thaddeus T. Sze, Ph.D., Chemical Engineer, DFI, and Kim A. Rice, Supervisory Investigator, SEA-DO, prepared a draft document with information obtained from FDA Center and Field personnel who are actively involved in biotech inspections.