PIC/S publishes the PIC/S Guide to Good Manufacturing Practice for Medicinal Products, document PE 009. It has a Part I for medicinal products, a Part II for active pharmaceutical ingredients and a set of annexes. The guide is kept closely aligned with the EU GMP Guide: Annex 11 on computerised systems and the 2022 Annex 1 on sterile manufacturing are shared texts, and Annex 1 was revised jointly by the European Commission and PIC/S with WHO involvement. Participating authorities use the guide as their national GMP standard or as the basis of it.
Because PIC/S is a scheme of inspectorates rather than a regulator in its own right, it does not inspect companies or approve products. A manufacturer meets PIC/S GMP by satisfying the national authority that inspects it — and that authority’s expectations are, by design, close to those of every other participating authority.
PIC/S data integrity guidance
PIC/S guidance PI 041, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, was published in 2021. It is written for inspectors but widely used by industry. It covers data governance systems, organisational influences on data integrity, the ALCOA+ principles, specific considerations for paper-based and computerised systems — including access, audit trails, data review, validation and supplier management — and the handling of data integrity failures and their remediation.
What that means for your systems
- Computerised systems validated for their intended use, with risk-based scope.
- Data protected against unauthorised change, with audit trails for GMP-relevant changes that are reviewed.
- Individual accountability — unique accounts, role-based access and meaningful electronic signatures.
- Data governance that covers the whole data lifecycle, paper as well as electronic.
- Quality system processes — deviations, CAPA, change control, supplier qualification — that are connected and effective.