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Full Description

This publication provides guidance on how a medical gas manufacturer can implement the quality systems approach to meet requirements of 21 CFR Parts 210 and 211. It is based on a review of the FDA's September 2006 Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations.
 

Document History

  1. CGA M-11


    Guideline for Compliance with the Quality Systems Approach to Current Good Manufacturing Practices

    • Most Recent
  2. CGA M-11

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    Compliance with the Quality Systems Approach to Pharmaceutical CGMPs Guidance, Second Edition

    • Historical Version
  3. CGA M-11


    Compliance with the Quality Systems Approach to Pharmaceutical CGMPs Guidance, First Edition

    • Historical Version