FDA publishes Q8/Q9/Q10 Implementation Document

On November 1, 2011 the USA FDA published the Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4). This guidance was developed within the Quality Implementation Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). According to the ICH process it has been subject to consultation by the regulatory parties. The answers to questions in this document have been endorsed by the ICH Steering Committee at Step 4 of the ICH process in April 2009, June 2009, October 2009, and November 2010. In Step 4 of the process, the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan, and the United States. The Q&A document was already published in Europe and in Japan.

The guidance reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances. The document contains the following topics:

  • Quality by Design
    - Design Space
    - Real Time Release Testing
    - Control Strategy
  • Pharmaceutical Quality System
  • Impact of new ICH Quality Guidance on GMP Inspection Practices
  • Knowledge Management
  • Sofware Solutions

Here you will find the FDA Guidance for Industry Q8, Q9, and Q10 Questions and Answers(R4)

Source: Press Release FDA

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