PIC/S GMP Guide (PE 009) - PIC/S Guide to Good Manufacturing Practice

What it says

Participating regulatory authorities apply a harmonized GMP standard, closely mirroring EU GMP in structure and content, to promote consistent GMP inspection standards and mutual recognition of inspection outcomes across the many national authorities that participate in the scheme.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Because the PIC/S GMP Guide closely tracks EU GMP, a site compliant with EU GMP chapters and annexes is generally well positioned for a PIC/S-aligned inspection, though jurisdiction-specific annotations or timing differences can still exist.
• Mutual recognition under PIC/S means a manufacturer's inspection history with one participating authority can carry weight with another, which is part of why consistent, defensible GMP documentation matters across every inspection, not just the next one scheduled.
• Manufacturers exporting to multiple PIC/S participating countries benefit from the harmonization this guide provides, since it reduces, though does not eliminate, the need to maintain entirely separate compliance postures per market.

What inspectors look for

• Whether the site's GMP documentation and quality system are structured consistently with the harmonized PIC/S and EU GMP format, supporting recognition across participating authorities.
• Whether any jurisdiction-specific annotations or additional national requirements layered onto the base PIC/S standard have been identified and addressed.
• Whether inspection history and corrective actions from one participating authority's inspection have been appropriately considered in preparing for inspections by others.

Related regulations