FDA Sterile Drug Process Inspections Guidelines


FDA Sterile Drug Process Inspections


This program covers the manufacture and testing of all sterile drug products, including drugs that are sterilized by filtration or other means and aseptically processed, and drug products that are terminally sterilized. The type of products covered by this program include sterile bulk drugs, ophthalmic drugs, otic dosage forms, small volume parenteral (SVS) products for small molecule and licensed biological therapeutic drug products, large volume parenteral (LVP) products, and any other drug products required to be sterile or labeled as sterile. Center for Biologics Evaluation and Research (CBER) regulated products and veterinary drug products are excluded from coverage under this program. The guidance information in this program is tailored to sterile manufacturing operations and should be used in conjunction with the Compliance Program for Drug Manufacturing Inspections (CP 7356.002). In 2004, Food and Drug Administration (FDA) published the Guidance for Industry Sterile Drug Products Produced by Aseptic Processing-- Current Good Manufacturing Practice, which is referred to throughout this Compliance Program as FDA’s “2004 Aseptic Processing Guidance.” The document represents FDA’s current thinking on Current Good Manufacturing Practices (CGMPs) for aseptically processed drugs.

The Guidance for Industry does not establish mandatory requirements and should not be referred to as the justification for an inspectional observation. Justification for inspectional observations originates from the CGMP regulations, 21 CFR Parts 210 and 211.

Manufacturers who follow the 2004 Aseptic Processing Guidance are generally considered compliant with CGMP regulations. However, alternate approaches may be used if such approaches satisfy the requirements of 21 CFR Parts 210 and 211.

For technical questions and unusual circumstances encountered during an inspection, investigators are encouraged to contact their District, ORA Office of Medical Products and Tobacco Operations/Division of Medical Products and Tobacco Program Operations and/or CDER for consultation. For questions concerning microbiological analysis, sterility and related sampling concerns, contact ORA Office of Regulatory Science/Medical Products and Tobacco Scientific Staff.

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FDA Sterile Drug Process Inspections Guidelines:

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