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
Annual Report 2019 AR 2019 Documents for the public Annual reports
Questions and Answers (Q&A) on the Implementation of Risk-Based Prevention of Cross-Contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits (HBEL) for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’ PI 053-1 Documents for Inspectors Guidance documents
Aide Memoire on the Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management PI 052-1 Documents for Inspectors Guidance documents
Participating Authorities PS/INF 21/2002 (Rev. 24) Documents for Inspectorates Inspectorates
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
PIC/S Guidelines for the Pre-Accession Procedure PS W 12 2019 Documents for Inspectorates Inspectorates
Revised PIC/S Scheme PICS 1/95 (Rev 6) Documents for Inspectorates Inspectorates
PIC/S Work Plan for 2020 PS W 37 2019 Documents for the public Information documents
Press Release December 2019 PR December 2019 Documents for the public Press releases
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
PIA Brochure 2019 Brochure Documents for the public Information documents
PIC/S Brochure 2019 Brochure Documents for the public Information documents
Press Release May 2019 PR May 2019 Documents for the public Press releases
Guidance on Classification of GMP Deficiencies PI 040-1 Documents for Inspectors Guidance documents