FDA guidance

Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for…

FDA guidance · Final · issued Sep 30, 2016

Key facts

Title Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry
Status Final
Issue date Sep 30, 2016
Center Center for Drug Evaluation and Research
Issuing office Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research
Communication type Guidance Document
Regulated product Drugs
Docket number FDA-1995-D-0288
Open for comment No
Document on fda.gov fda.gov

At a glance

  • None Product codes referenced
  • None Recognized standards referenced

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FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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