Drug Regulators,FDA, Publish ICH Questions and Answers, Q8,Q9 and Q10
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Since the Q8, Q9, and Q10 guidances were made final, experiences implementing the guidances in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to clarify key issues. 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 benefits of harmonizing technical requirements across the ICH regions can be realized only if the various quality ICH guidances are implemented and interpreted in a consistent way across the three regions. The Q-IWG is tasked to develop Q&As to facilitate implementation of existing quality guidance.
Q8 (R2) Pharmaceutical Development (includes the Q8 parent guidance (Part I) and the annex (Part II), which provides further clarification of the Q8 parent guidance and describes the principles of quality by design)
Q9 Quality Risk Management
Q10 Pharmaceutical Quality Systems
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