Valid Metod Anal
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J:/guidance/2396.dft.wpd 08/29/00 Guidance for Industry Analytical Procedures and Methods Validation Chemistry, Manufacturing, and Controls Documentation DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rock ville, MD 20852. All comments should be ide ntified with the docket number listed in the notice of availability that publishes in the Federal Register . For questions on the contents of this draft document contact (CDER) Radhika Rajagopalan, 301- 827-5849 or (CBER) Alfred Del Grosso, 301-435-4988. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) August 2000 CMC #
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