ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA

The ICH document Q8,Q9, & Q10, Questions and Answers / Appendix Q&As from Training Sessions has also been published in the United States as Guidance for Industry in July 2012.

As regards the specifications and certificates of analysis for Real-Time Release Testing (RTRT) the following points are considered to be particularly relevant:

  • quality attributes (not all CQAs need to be included in the specification), 
  • methods of control (the type of control used, such as PAT must be indicated), 
  • acceptance criteria (directly at the control point as well as later on, criteria for stability and regulatory testing) 
  • elements of the certificate of analysis (e.g., the results of analysis as values calculated from models or established calibrations, and actual test results).

The contents of this document are not intended to be a new Guideline. They are intended to provide clarity to both industry and regulators and to facilitate the preparation, assessment, and inspection related to applications filed for marketing authorisations that have been prepared using the Quality by Design (QbD) approach.

"Real Time Release Testing" is also one of the key topics addressed at the University of Heidelberg QbD/PAT Conference 2012 on 26 and 27 September 2012 at the Marriott Hotel in Heidelberg. Apart form leading industry representatives from the United States (Steve Hammond, Pfizer and Dr Gert Thurau, MSD) Sven-Erik Hillver from the Swedish Medicines Agency will also speak about the European Requirements concerning RTRT. He took an active part in preparing the new EMA RTRT Guideline. Also read our News dated 22 August 2012.

More information is available in the complete FDA Guidance for Industry - Q8, Q9, & Q10 Questions and Answers.

Dr. Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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