FDA guidance

Q10 Pharmaceutical Quality System

FDA guidance · Final · issued Apr 8, 2009

Key facts

Title Q10 Pharmaceutical Quality System
Status Final
Issue date Apr 8, 2009
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-2007-D-0370
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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About FDA guidance documents

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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