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Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry


Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993-0002 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 Email:

Document Type:
Guidance for Indutry
This guidance describes chemistry, manufacturing, and controls (CMC) postapproval changes related to disposable manufacturing materials that applicants can pursue in drug and biological product manufacturing. This guidance applies to biologics license application (BLA) products licensed under section 351(a) or 351(k) of the Public Health Service Act (PHS Act); human drug products marketed as new drug applications (NDAs) or abbreviated new drug applications (ANDAs) under section 505(b)(1), 505(b)(2), or 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and animal drugs marketed as new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) under section 512(b)(1) or 512(b)(2) of the FD&C Act. This guidance applies to all manufacturing establishments, including those that perform functions under contract as defined in the guidance for industry Contract Manufacturing Arrangements for Drugs: Quality Agreements (November 2016).

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