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GUIDANCE DOCUMENT

Analytical Procedures and Methods Validation for Drugs and Biologics July 2015

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-N-0007
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance supersedes the draft of the same name that published on February 19, 2014 (79 FR 9467) and replaces the 2000 draft guidance for industry on Analytical Procedures and Methods Validation and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods Validation. It provides recommendations on how you, the applicant, can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products.

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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
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All written comments should be identified with this document's docket number: FDA-2015-N-0007.

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