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 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
PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments PI 041-1 Documents for Inspectors Guidance documents
PIC/S Aide Memoire to Inspections of Blood Establishments and Plasma Warehouses PI 008-4 Documents for Inspectors Aide-Memoires
PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks PE 005-4 Documents for Inspectors Guidance documents
PIC/S GMP Guide (Related Annexes) PE 009-15 (Annexes) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients) PE 009-15 (Part II) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products) PE 009-15 (Part I) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Introduction) PE 009-15 (Intro) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (zip) PE 009-15 Documents for Industry PIC/S GMP Guide
PIC/S Work Plan for 2021 PS W 01 2021 Documents for the public Information documents
Aide Memoire on Assessment of Quality Risk Management (QRM) Implementation PI 038-2 Documents for Inspectors Aide-Memoires
Aide-Memoire on Packaging PI 028-2 Documents for Inspectors Aide-Memoires
Aide Memoire on Inspection of Biotech PI 024-3 Documents for Inspectors Aide-Memoires