• Q9 Quality Risk Management

    Code Document Title Previously coded
    • Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 2005.
      This Guideline provides principles and examples of tools of quality risk management that can be applied to all aspects of pharmaceutical quality including development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances and drug (medicinal) products, biological and biotechnological products, including the use of raw materials, solvents, excipients, packaging and labeling materials.

      Implementation :

      Step 5

      :

      EC, EuropePublished on the EMA website with an Explanatory Note, January 2006, issued as EXT/24235/2006

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      MHLW/PMDA, Japan Adopted September 2006, PFSB/ELD Notification No. 0901004

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      FDA, US Published in the Federal Register, 2 June 2006, Vol. 71, No. 106, p. 32105-6

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      Health Canada, Canada Implemented 05 February 2016 File #: 16-100155-230

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