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GMP Published

PIC/S Guide to Good Manufacturing Practice for Medicinal Products - Part II

Part II of the PIC/S GMP Guide (PE 009): basic requirements for active substances used as starting materials. Harmonised with EudraLex Volume 4 Part II / ICH Q7.

Organizations:
Pharmaceutical Inspection Co-operation Scheme (PIC/S)

Version Timeline

Chronological release history

PE 009-18

Version milestone

Published en

Publication Date

Sep 23, 2026

Effective Date

Sep 24, 2026

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