FDA Guidance On ICH Q8-10

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This FDA guidance, FDA - Guidance for Industry - Q8, Q9, and Q10 - Questions and Answers, reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.

The guidance, in Q & A format covers:

• 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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