Publications

Since its creation, PIC/S has been active in the development and promotion of harmonised GMP standards and guidance documents.

The main instrument for harmonisation has been the PIC/S GMP Guide. Originally, the latter derives from the WHO GMP Guide and has been further developed in order to comply with stringent manufacturing and health requirements, to cover new areas (e.g. biologicals) and to adapt to scientific and industrial technology (e.g. biotech).

In 1989, the EU adopted its own GMP Guide, which - in terms of GMP requirements - is equivalent to the PIC/S GMP Guide. Since that time, the EU and the PIC/S GMP Guides have been developed in parallel (both Guides are practically identical).

In addition to the GMP Guide, PIC/S has also been a pioneer in developing a number of guidelines and guidance documents such as the Site Master File, the Recommendation on Quality System Requirements for Pharmaceutical Inspectorates and the first Guideline for the Manufacture of Active Pharmaceutical Ingredients. As a matter of fact, PIC/S has been instrumental in elaborating a first draft for the ICH Q7A Guide on APIs, which was finalised by ICH in 2000 and then adopted by PIC/S.

All PIC/S documents publically available are listed below and appear in alphabetical order. Protected documents are for PIC/S Members-only and require a login.

Latest Reference Category Section
PIC/S Work Plan for 2022 PS W 13 2022 Documents for the public Information documents
PIC/S Guidelines for the Pre-Accession Procedure PS W 12 2019 (Rev. 1) Documents for Inspectorates Inspectorates
PIC/S Guidelines for Accession PS W 14 2011 (Rev. 3) Documents for Inspectorates Inspectorates
Annual Report 2021 AR 2021 Documents for the public Annual reports
Participating Authorities PS/INF 21/2002 (Rev. 26) Documents for Inspectorates Inspectorates
PIC/S GMP Guide (zip) PE 009-16 Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Related Annexes) PE 009-16 (Annexes) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients) PE 009-16 (Part II) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products) PE 009-16 (Part I) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Introduction) PE 009-16 (Intro) Documents for Industry PIC/S GMP Guide
Concept Paper on the Revision of Annex 5 of the Guidelines on Good Manufacturing Practice for Medicinal Products | Manufacture of Immunological Veterinary Medicinal Products Concept Paper on the Revision of EU-PIC/S GMP Annex 5 Documents for Industry PIC/S GMP Guide
Concept Paper on the Revision of Annex 4 of the Guidelines on Good Manufacturing Practice | Manufacture of Veterinary Medicinal Products other than Immunologicals Concept Paper on the Revision of EU-PIC/S GMP Annex 4 Documents for Industry PIC/S GMP Guide
Annual Report 2020 AR 2020 Documents for the public Annual reports
PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections PI 055-1 Documents for Inspectors Guidance documents
PIC/S Recommendation How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management PI 054-1 Documents for Inspectors Guidance documents