Transcription of ICH Q10 Pharmaceutical Quality System
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ICH Q10 Pharmaceutical Quality System
International Conference on Harmonisation of TechnicalRequirements for Registration of Pharmaceuticals for Human UseICH Q10 Pharmaceutical Quality System (PQS)2 ICH Q10 PQS Guideline Background Objectives Scope Content Implementation Conclusion3 Background high level more visionary less prescriptive flexible regulatory approaches ICH Q8 Pharmaceutical development ICH Q9 Quality Risk Management ICH Q10 Pharmaceutical Quality System Vision Move from regulatory guidance to scientific guidance A harmonized Pharmaceutical Quality systemapplicable across the lifecycleof the product emphasizing an integrated approach to qualityrisk managementand science Companion guidelines 4 Background(continued) ICH Q8 Finalized November 2005 ICH Q8(R1) (Step 2)
3 Background high level more visionary less prescriptive flexible regulatory approaches ¾ICH Q8 Pharmaceutical Development ¾ICH Q9 Quality Risk Management ¾ICH Q10 ...
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