• Pharmacopoeias Q4 - Q4B

    Code Document Title Previously coded
    • Q4B Annex 4AR1Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter

      Finalise Annex:
      September 2010

      Q4B Annex 4A(R1)
      Description:

      The tripartite harmonised ICH annex was finalised under Step 4 in November 2008.
      This annex is the result of the Q4B process for Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests General Chapter.

      This annex was revised -R1- to include the Interchangeability Statement from Health Canada on 27 September 2010.

      Implementation:

      Step 5

      EU:

      Adopted by CHMP, December 2008, issued as CHMP/ICH/308671/07

      MHLW:

      Adopted 17 September 2010, PFSB/ELD Notification No. 0917-2

      FDA:

      Published in the Federal Register, 8 April 2009, Vol. 74, No. 66, p. 15991-2

      Frequently Asked Questions

      Finalised Document:
      April 2012

      Q4B FAQs
      Description:

      The Q4B Expert Working Group (EWG) developed a set of Frequently Asked Questions (FAQs) to help users of the Q4B Guideline and Annexes to understand the use and implication of these documents.