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.

All Reference Category Section
PIC/S GMP Guide (zip) PE 009-13 Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Related Annexes) PE 009-13 (Annexes) Documents for Industry PIC/S GMP Guide
PIC/S Letter of Agreement with EEA HMA PS/W 18/2016 Documents for Inspectorates Inspectorates
Participating Authorities PS/INF 21/2002 (Rev. 22) Documents for Inspectorates Inspectorates
Draft PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments PI 041-1 (Draft 2) Documents for Inspectors Guidance documents
Press Release July 2016 PR Jul 2016 Documents for the public Press releases
Annual Report 2015 AR 2015 Documents for the public Annual reports
PIC/S Brochure 2016 Brochure Documents for the public Information documents
Annual Report 2014 AR 2014 Documents for the public Annual reports
Procedure on Notification of Foreign Inspections PI 039-1 Documents for Inspectorates Inspectorates
Press Release November 2015 PR Nov 2015 Documents for the public Press releases
PIC/S GMP Guide (Part II: Basic Requirements for Active Pharmaceutical Ingredients) PE 009-13 (Part II) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Part I: Basic Requirements for Medicinal Products) PE 009-13 (Part I) Documents for Industry PIC/S GMP Guide
PIC/S GMP Guide (Introduction) PE 009-13 (Intro) Documents for Industry PIC/S GMP Guide
Press Release May 2015 PR May 2015 Documents for the public Press releases
Joint PIC/S-EMA Concept Paper On The Revision Of Annex 1 PS W 01 2015 Documents for Industry PIC/S GMP Guide
Press Release November 2014 PR Nov 2014 Documents for the public Press releases
PIC/S Audit Checklist PS W 01 2005 (Rev 2) Documents for Inspectorates Inspectorates
PIC/S FAQ (Frequently Asked Questions) PS INF 18 2014 (Draft 1) Documents for the public Information documents
Annual Report 2013 AR 2013 Documents for the public Annual reports
PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products PE 011-1 Documents for Inspectors Guidance documents
Press Release May 2014 PR May 2014 Documents for the public Press releases
Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments PE 010-4 Documents for Inspectors Guidance documents
PIC/S Guidelines for Accession PS W 14 2011 (Rev. 1) Documents for Inspectorates Inspectorates
Press Release November 2013 PR Nov 2013 Documents for the public Press releases
Annual Report 2012 AR 2012 Documents for the public Annual reports
Press Release May 2013 PR May 2013 Documents for the public Press releases
QA on Traceability of Medicinal Gases PS INF 06 2012 (Rev 1) Documents for Inspectors Q&A Documents
Press Release October 2012 PR Oct 2012 Documents for the public Press releases
Annual Report 2011 AR 2011 Documents for the public Annual reports
Press Release May 2012 PR May 2012 Documents for the public Press releases
Aide Memoire on Assessment of QRM Implementation PI 038-1 Documents for Inspectors Aide-Memoires
PIC/S Recommendation on Risk-Based Inspection Planning PI 037-1 Documents for Inspectors Guidance documents
Press Release November 2011 PR Nov 2011 Documents for the public Press releases
PIC/S Scheme PICS 1/95 (Rev 5) Documents for Inspectorates Inspectorates
Annual Report 2010 AR 2010 Documents for the public Annual reports
Questionnaire for Assessment PS W 01 2011 Documents for Inspectorates Inspectorates
Press Release No 2 June 2011 PR 02 Jun 2011 Documents for the public Press releases
Press Release No 1 June 2011 PR 01 Jun 2011 Documents for the public Press releases
QA Distribution Activities for APIs - May 2010 PS INF 20 2011 Documents for Inspectors Q&A Documents
Validation of Aseptic Processes PI 007-6 Documents for Inspectors Guidance documents
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects PI 010-4 Documents for Inspectorates Inspectorates
Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File PE 008-4 Documents for Industry Site Master Files
Press Release November 2010 PR Nov 2010 Documents for the public Press releases
Annual Report 2009 AR 2009 Documents for the public Annual reports
Press Release May 2010 PR May 2010 Documents for the public Press releases
Technical Interpretation of Revised Annex 1 to PIC/S GMP Guide PI 032-2 Documents for Inspectors Guidance documents
Example of Quality Risk Management Implementation PS/INF 1/2010 Documents for the public Miscellaneous
Press Release November 2009 PR Nov 2009 Documents for the public Press releases
Standard Operating Procedure Team Inspections PI 031-1 Documents for Inspectorates Inspectorates
Annual Report 2008 AR 2008 Documents for the public Annual reports
Press Release May 2009 PR May 2009 Documents for the public Press releases
Aide-Memoire on the Inspection of APIs PI 030-1 Documents for Inspectors Aide-Memoires
Aide-Memoire on Packaging PI 028-1 Documents for Inspectors Aide-Memoires
Press Release November 2008 PR Nov 2008 Documents for the public Press releases
Annual Report 2007 AR 2007 Documents for the public Annual reports
Press Release May 2008 PR May 2008 Documents for the public Press releases
Press Release November 2007 PR Nov 2007 Documents for the public Press releases
Isolators Used for Aseptic Processing and Sterility Testing PI 014-3 Documents for Inspectors Guidance documents
Recommendation on Sterility Testing PI 012-3 Documents for Inspectors Guidance documents
Good Practices for Computerised Systems in Regulated GXP Environments PI 011-3 Documents for Inspectors Guidance documents
PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (Inspection Guide) PI 008-3 Documents for Inspectors Guidance documents
Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation PI 006-3 Documents for Inspectors Guidance documents
Guidance on Parametric Release PI 005-3 Documents for Inspectors Guidance documents
PIC/S GMP Guide for Blood Establishments PE 005-3 Documents for Inspectors Guidance documents
Aide-Memoire on Medicinal Gases PI 025-2 Documents for Inspectors Aide-Memoires
Aide Memoire on Inspection of Biotech PI 024-2 Documents for Inspectors Aide-Memoires
Aide Memoire on Inspection of Quality Control Laboratories PI 023-2 Documents for Inspectors Aide-Memoires
Aide Memoire on GMP Particularities for Clinical Trial Products PI 021-2 Documents for Inspectors Aide-Memoires
Aide-Memoire Inspection of Utilities PI 009-3 Documents for Inspectors Aide-Memoires
Standard Operating Procedure PIC/S Inspection Report Format PI 013-3 Documents for Inspectorates Inspectorates
Site Master File for Plasma Warehouses PI 020-3 Documents for Industry Site Master Files
Quality System Requirements For Pharmaceutical Inspectorates PI 002-3 Documents for Inspectorates Inspectorates
Site Master File for Source Plasma Establishments PI 019-3 Documents for Industry Site Master Files
Annual Report 2006 AR 2006 Documents for the public Annual reports
Press Release May 2007 PR May 2007 Documents for the public Press releases
Press Release December 2006 PR Dec 2006 Documents for the public Press releases
Annual Report 2005 AR 2005 Documents for the public Annual reports
Press Release June 2006 PR Jun 2006 Documents for the public Press releases
PIC/S Blueprint PS W 8 2005 Documents for the public Information documents
Annual Report 2004 AR 2004 Documents for the public Annual reports
Press Release February 2005 PR Feb 2005 Documents for the public Press releases
Annual Report 2003 AR 2003 Documents for the public Annual reports
Press Release June 2004 PR Jun 2004 Documents for the public Press releases
Press Release November 2003 PR Nov 2003 Documents for the public Press releases
Annual Report 2002 AR 2002 Documents for the public Annual reports
Press Release June 2003 PR Jun 2003 Documents for the public Press releases
Annual Report 2001 AR 2001 Documents for the public Annual reports
Press Release May 2002 PR May 2002 Documents for the public Press releases
Annual Report 2000 AR 2000 Documents for the public Annual reports
Non-Technical Aspects of Inspection (PIC/S Seminar 1999 Booklet) PS INF 72 2000 Documents for the public Information documents
Annual Report 1999 AR 1999 Documents for the public Annual reports
PIC Convention of 1970 PIC Convention Documents for Inspectorates Inspectorates