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.

Draft Reference Category Section
2nd Targeted Consultation Document on Revision of Annex 1 (Manufacture of Sterile Medicinal Products) 2nd Targeted Consultation Document on Revision of Annex 1 Documents for Industry PIC/S GMP Guide
Draft PIC/S Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management PI 054-1 (Draft 1) Documents for Inspectors Guidance documents
PIC/S Concept Note on a Recommendation on How to Evaluate / Demonstrate the Effectiveness of a Pharmaceutical Quality System in relation to Risk-based Change Management PS INF 88 2019 Documents for Inspectors Guidance documents
Draft Annex 2B (Manufacture of biological medicinals) to PIC/S GMP Guide for Public Consultation PS INF 26 2019 (Rev. 1) Draft Documents for Industry PIC/S GMP Guide
Draft Annex 2A (Manufacture of ATMP) to PICS GMP Guide for Public Consultation PS INF 25 2019 (Rev. 1) Draft Documents for Industry PIC/S GMP Guide
Consultation Notice on Revision Annex 2 PS INF 24 2019 Documents for Industry PIC/S GMP Guide
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