• Q10 Pharmaceutical Quality System

    Code Document Title Previously coded
    • Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in June 2008.
      This Guideline applies to pharmaceutical drug substances and drug products, including biotechnology and biological products, throughout the product lifecycle.
      The elements of Q10 should be applied in a manner that is appropriate and proportionate to each of the product lifecycle stages, recognising the differences among, and the different goals of each stage.

      Implementation :

      Step 5

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      EC, EuropeAdopted by CHMP, July 2008, issued as CHMP/ICH/214732/04

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      MHLW/PMDA, Japan Adopted 19 February 2010, PFSB/ ELD Notification No. 0219-1 & PFSB/ NCD Notification No. 0219-1

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      FDA, US Published in the Federal Register, 8 April 2009, Vol. 74, No. 66, p. 15990-1

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      Health Canada, Canada Implemented 15 February 2016 File #: 16-101419-273

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      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website