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
Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments PI 041-1 (Draft 3) Documents for Inspectors Guidance documents
Press Release October 2018 PR October 2018 Documents for the public Press releases
PIC/S Brochure 2018 Brochure Documents for the public Information documents
PIC/S GMP Guide (Introduction) PE 009-14 (Intro) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products) PE 009-14 (Part I) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients) PE 009-14 (Part II) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Related Annexes) PE 009-14 (Annexes) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (zip) PE 009-14 Documents for Industry PIC/S GMP Guide
Aide-Memoire on Cross-Contamination in Shared Facilities PI 043-1 Documents for Inspectors Aide-Memoires
PIC/S Guidelines on GDP of Active Substances for Human Use PI 047-1 Documents for Inspectors Guidance documents
PIC/S Guideline on Exposure Limits PI 046-1 Documents for Inspectors Guidance documents
PIC/S Guidelines on Excipient GMP Risk Assessment PI 045-1 Documents for Inspectors Guidance documents
Annual Report 2017 AR 2017 Documents for the public Annual reports
Public Summary Version of PIC/S Road Map 2018-2020 PS W 10 2018 Documents for the public Information documents
Guidance on GMP Inspection Reliance PI 048-1 Documents for Inspectorates Inspectorates