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PIC/S GMP Guide Revised Chapters 3, 5, 8 and Annex 17

PIC/S has revised Chapters 3, 5, 8 and Annex 17 of the GMP Guide (PE 009-14), aligning them with EU GMP principles and Quality Risk Management. Key changes include new cross-contamination prevention requirements in Chapters 3 and 5, updated supplier qualification requirements, and expanded quality defect evaluation expectations in Chapter 8. The revision entered into force on 1 July 2018.

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