GMP Auditing & Consulting LLC — Reference Docket

PIC/S GMP Guide Index

The PIC/S GMP Guide (PE 009), its Annexes, and PIC/S-specific inspector guidance documents, organized by product category — every entry links to its source. Search by keyword or PE/PI number.

— entries indexed Current guide: PE 009-17 (eff. 25 Aug 2023)

Overall Index

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A GMP Auditing & Consulting LLC resource.

The PIC/S GMP Guide (PE 009) is text-harmonized with EudraLex Volume 4 — PIC/S adopts the EU GMP chapters and annexes essentially verbatim, then extends them across its 50+ participating regulatory authorities worldwide. This library is weighted toward what's genuinely distinct about PIC/S: its inspector-facing guidance — aide-memoires, recommendations, and documents such as PI 041-1 on data integrity — that sit outside EudraLex entirely. (For the underlying GMP text itself, see our companion EU GMP index.) Citations link to the official PIC/S Publications page at picscheme.org. PIC/S periodically revises its guide version — currently PE 009-17, effective 25 August 2023 — and we review this library on the same basis. Corrections welcome at gmpauditingandconsultingllc@gmail.com. This index is a navigational aid, not legal or regulatory advice.