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 Aide Memoire on Remote Assessment | PI 057-1 | Documents for Inspectors | Guidance documents |
PIC/S Guidance on Remote Assessments | PI 056-1 | Documents for Inspectors | Guidance documents |
Annual Report 2023 | AR 2023 | Documents for the public | Annual reports |
Job Description for PIC/S Secretary / Executive Director | PS ADM 3 2024 | Documents for the public | Information documents |
PIC/S Brochure 2023 | Brochure | Documents for the public | Information documents |
Participating Authorities | PS/INF 21/2002 (Rev. 28) | Documents for Inspectorates | Inspectorates |
Annual Report 2022 | AR 2022 | Documents for the public | Annual reports |
PIC/S GMP Guide (PE 009-17) Introduction | PE 009-17 (Intro) | Documents for Industry | PIC/S GMP Guide |
PIC/S GMP Guide (PE 009-17) Part I | PE 009-17 (Part I) | Documents for Industry | PIC/S GMP Guide |
PIC/S GMP Guide (PE 009-17) Part II | PE 009-17 (Part II) | Documents for Industry | PIC/S GMP Guide |
PIC/S GMP Guide (PE 009-17) Annexes | PE 009-17 (Annexes) | Documents for Industry | PIC/S GMP Guide |
PIC/S Work Plan for 2023 | PS W 03 2023 | Documents for the public | Information documents |
PIC/S Aide Memoire Inspection of GDP for Medicinal Products in the Supply Chain | PI 044-1 | Documents for Inspectors | Guidance documents |
QA on PIC/S GDP Guide (PE 011-1) | PS INF 22 2017 | Documents for Inspectors | Q&A Documents |
Concept Paper on the Revision of Annex 11 of the Guidelines on Good Manufacturing Practice for Medicinal Products | Computerised Systems | Concept Paper on the Revision of EU-PIC/S GMP Annex 11 | Documents for Industry | PIC/S GMP Guide |
2023-2027 PIC/S Strategic Plan | PS W 15 2022 | Documents for the public | Information documents |
PIC/S Work Plan for 2022 | PS W 13 2022 | Documents for the public | Information documents |
PIC/S Guidelines for the Pre-Accession Procedure | PS W 12 2019 (Rev. 1) | Documents for Inspectorates | Inspectorates |
PIC/S Guidelines for Accession | PS W 14 2011 (Rev. 3) | Documents for Inspectorates | Inspectorates |
Questionnaire for Assessment | PS W 01 2011 (Rev. 1) | Documents for Inspectorates | Inspectorates |
PIC/S Audit Checklist | PS W 01 2005 (Rev. 3) | Documents for Inspectorates | Inspectorates |
Annual Report 2021 | AR 2021 | Documents for the public | Annual reports |
Concept Paper on the Revision of Annex 5 of the Guidelines on Good Manufacturing Practice for Medicinal Products | Manufacture of Immunological Veterinary Medicinal Products | Concept Paper on the Revision of EU-PIC/S GMP Annex 5 | Documents for Industry | PIC/S GMP Guide |
Concept Paper on the Revision of Annex 4 of the Guidelines on Good Manufacturing Practice | Manufacture of Veterinary Medicinal Products other than Immunologicals | Concept Paper on the Revision of EU-PIC/S GMP Annex 4 | Documents for Industry | PIC/S GMP Guide |
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 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 |
Aide-Memoire Inspection of Utilities | PI 009-4 | Documents for Inspectors | Aide-Memoires |
PIC/S Audit Checklist - Interpretation Guide | PS W 31 2019 | Documents for Inspectorates | Inspectorates |
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 |
Revised PIC/S Scheme | PICS 1/95 (Rev 6) | Documents for Inspectorates | Inspectorates |
PIC/S Work Plan for 2020 | PS W 37 2020 | Documents for the public | Information documents |
Press Release December 2019 | PR December 2019 | Documents for the public | Press releases |
PIA Brochure 2019 | Brochure | Documents for the public | Information documents |
Annual Report 2018 | AR 2018 | Documents for the public | Annual reports |
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 |
PIC/S Work Plan for 2019 | PS W 18 2018 | Documents for the public | Information documents |
Press Release October 2018 | PR October 2018 | Documents for the public | Press releases |
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 |
Press Release May 2018 | PR May 2018 | Documents for the public | Press releases |
Press Release October 2017 | PR October 2017 | Documents for the public | Press releases |
Annual Report 2016 | AR 2016 | Documents for the public | Annual reports |
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects | PI 010-5 | Documents for Inspectorates | Inspectorates |
Press Release March 2017 | PR March 2017 | Documents for the public | Press releases |
Press Release July 2016 | PR Jul 2016 | Documents for the public | Press releases |
Annual Report 2015 | AR 2015 | Documents for the public | Annual reports |
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 |
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 (Manufacture of Sterile Medicinal Products) | PS W 01 2015 | Documents for Industry | PIC/S GMP Guide |
Press Release November 2014 | PR Nov 2014 | Documents for the public | Press releases |
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 |
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 |
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 |
Annual Report 2010 | AR 2010 | Documents for the public | Annual reports |
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 |
Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) | 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 |
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 Active Pharmaceutial Ingredients (APIs) | PI 030-1 | 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 |
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 |
Aide-Memoire on Medicinal Gases | PI 025-2 | 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 |
Standard Operating Procedure PIC/S Inspection Report Format | PI 013-3 | Documents for Inspectorates | Inspectorates |
Site Master File (SMF) 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 (SMF) 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 |
Recommendation on the Qualification and Training of Inspectors in the Field of Human Blood Tissues and Cells | PI 026-2 | Documents for Inspectors | Guidance documents |
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 |
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 |