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GUIDANCE DOCUMENT

Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry July 2022

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-6821
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-6821.

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