| 2023-2027 PIC/S Strategic Plan | PS W 15 2022 | 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 GMP Particularities for Clinical Trial Products | PI 021-2 | Documents for Inspectors | Aide-Memoires |
| Aide Memoire on Inspection of Biotech | PI 024-3 | Documents for Inspectors | Aide-Memoires |
| Aide Memoire on Inspection of Quality Control Laboratories | PI 023-2 | Documents for Inspectors | Aide-Memoires |
| 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 |
| Aide-Memoire Inspection of Utilities | PI 009-4 | Documents for Inspectors | Aide-Memoires |
| Aide-Memoire on Cross-Contamination in Shared Facilities | PI 043-1 | Documents for Inspectors | Aide-Memoires |
| Aide-Memoire on Medicinal Gases | PI 025-2 | Documents for Inspectors | Aide-Memoires |
| Aide-Memoire on Packaging | PI 028-2 | Documents for Inspectors | Aide-Memoires |
| Aide-Memoire on the Inspection of Active Pharmaceutial Ingredients (APIs) | PI 030-1 | Documents for Inspectors | Aide-Memoires |
| Annual Report 1999 | AR 1999 | Documents for the public | Annual reports |
| Annual Report 2000 | AR 2000 | Documents for the public | Annual reports |
| Annual Report 2001 | AR 2001 | Documents for the public | Annual reports |
| Annual Report 2002 | AR 2002 | Documents for the public | Annual reports |
| Annual Report 2003 | AR 2003 | Documents for the public | Annual reports |
| Annual Report 2004 | AR 2004 | Documents for the public | Annual reports |
| Annual Report 2005 | AR 2005 | Documents for the public | Annual reports |
| Annual Report 2006 | AR 2006 | Documents for the public | Annual reports |
| Annual Report 2007 | AR 2007 | Documents for the public | Annual reports |
| Annual Report 2008 | AR 2008 | Documents for the public | Annual reports |
| Annual Report 2009 | AR 2009 | Documents for the public | Annual reports |
| Annual Report 2010 | AR 2010 | Documents for the public | Annual reports |
| Annual Report 2011 | AR 2011 | Documents for the public | Annual reports |
| Annual Report 2012 | AR 2012 | Documents for the public | Annual reports |
| Annual Report 2013 | AR 2013 | Documents for the public | Annual reports |
| Annual Report 2014 | AR 2014 | Documents for the public | Annual reports |
| Annual Report 2015 | AR 2015 | Documents for the public | Annual reports |
| Annual Report 2016 | AR 2016 | Documents for the public | Annual reports |
| Annual Report 2017 | AR 2017 | Documents for the public | Annual reports |
| Annual Report 2018 | AR 2018 | Documents for the public | Annual reports |
| Annual Report 2019 | AR 2019 | Documents for the public | Annual reports |
| Annual Report 2020 | AR 2020 | Documents for the public | Annual reports |
| Annual Report 2021 | AR 2021 | Documents for the public | Annual reports |
| Annual Report 2022 | AR 2022 | Documents for the public | Annual reports |
| 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 |
| 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 |
| 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 |
| Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) | PE 008-4 | Documents for Industry | Site Master Files |
| Good Practices for Computerised Systems in Regulated GXP Environments | PI 011-3 | Documents for Inspectors | Guidance documents |
| Guidance on Classification of GMP Deficiencies | PI 040-1 | Documents for Inspectors | Guidance documents |
| Guidance on GMP Inspection Reliance | PI 048-1 | Documents for Inspectorates | Inspectorates |
| Guidance on Parametric Release | PI 005-3 | Documents for Inspectors | Guidance documents |
| Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments | PE 010-4 | Documents for Inspectors | Guidance documents |
| Isolators Used for Aseptic Processing and Sterility Testing | PI 014-3 | Documents for Inspectors | Guidance documents |
| 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 |
| Non-Technical Aspects of Inspection (PIC/S Seminar 1999 Booklet) | PS INF 72 2000 | Documents for the public | Information documents |
| Participating Authorities | PS/INF 21/2002 (Rev. 28) | Documents for Inspectorates | Inspectorates |
| PIA Brochure 2019 | Brochure | Documents for the public | Information documents |
| PIC Convention of 1970 | PIC Convention | Documents for Inspectorates | Inspectorates |
| PIC/S Aide Memoire Inspection of GDP for Medicinal Products in the Supply Chain | PI 044-1 | 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 Audit Checklist | PS W 01 2005 (Rev. 3) | Documents for Inspectorates | Inspectorates |
| PIC/S Audit Checklist – Interpretation Guide | PS W 31 2019 | Documents for Inspectorates | Inspectorates |
| PIC/S Blueprint | PS W 8 2005 | Documents for the public | Information documents |
| PIC/S Brochure 2022 | Brochure | Documents for the public | Information documents |
| 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 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 Good Practice Guidelines for Blood Establishments and Hospital Blood Banks | PE 005-4 | 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 Guidance COVID-19 Risk Assessment for Routine On-Site Inspections | PI 055-1 | Documents for Inspectors | Guidance documents |
| PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products | PE 011-1 | Documents for Inspectors | Guidance documents |
| PIC/S Guideline on Exposure Limits | PI 046-1 | Documents for Inspectors | Guidance documents |
| PIC/S Guidelines for Accession | PS W 14 2011 (Rev. 3) | Documents for Inspectorates | Inspectorates |
| PIC/S Guidelines for the Pre-Accession Procedure | PS W 12 2019 (Rev. 1) | Documents for Inspectorates | Inspectorates |
| PIC/S Guidelines on Excipient GMP Risk Assessment | PI 045-1 | Documents for Inspectors | Guidance documents |
| PIC/S Guidelines on GDP of Active Substances for Human Use | PI 047-1 | 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 Recommendation on Risk-Based Inspection Planning | PI 037-1 | Documents for Inspectors | Guidance documents |
| PIC/S Work Plan for 2019 | PS W 18 2018 | Documents for the public | Information documents |
| PIC/S Work Plan for 2020 | PS W 37 2020 | Documents for the public | Information documents |
| PIC/S Work Plan for 2021 | PS W 01 2021 | Documents for the public | Information documents |
| PIC/S Work Plan for 2022 | PS W 13 2022 | Documents for the public | Information documents |
| Press Release December 2006 | PR Dec 2006 | Documents for the public | Press releases |
| Press Release December 2019 | PR December 2019 | Documents for the public | Press releases |
| Press Release February 2005 | PR Feb 2005 | Documents for the public | Press releases |
| Press Release July 2016 | PR Jul 2016 | Documents for the public | Press releases |
| Press Release June 2003 | PR Jun 2003 | Documents for the public | Press releases |
| Press Release June 2004 | PR Jun 2004 | Documents for the public | Press releases |
| Press Release June 2006 | PR Jun 2006 | Documents for the public | Press releases |
| Press Release March 2017 | PR March 2017 | Documents for the public | Press releases |
| Press Release May 2002 | PR May 2002 | Documents for the public | Press releases |
| Press Release May 2007 | PR May 2007 | Documents for the public | Press releases |
| Press Release May 2008 | PR May 2008 | Documents for the public | Press releases |
| Press Release May 2009 | PR May 2009 | Documents for the public | Press releases |
| Press Release May 2010 | PR May 2010 | Documents for the public | Press releases |
| Press Release May 2012 | PR May 2012 | Documents for the public | Press releases |
| Press Release May 2013 | PR May 2013 | Documents for the public | Press releases |
| Press Release May 2014 | PR May 2014 | Documents for the public | Press releases |
| Press Release May 2015 | PR May 2015 | Documents for the public | Press releases |
| Press Release May 2018 | PR May 2018 | Documents for the public | Press releases |
| Press Release May 2019 | PR May 2019 | Documents for the public | Press releases |
| Press Release No 1 June 2011 | PR 01 Jun 2011 | Documents for the public | Press releases |
| Press Release No 2 June 2011 | PR 02 Jun 2011 | Documents for the public | Press releases |
| Press Release November 2003 | PR Nov 2003 | Documents for the public | Press releases |
| Press Release November 2007 | PR Nov 2007 | Documents for the public | Press releases |
| Press Release November 2008 | PR Nov 2008 | Documents for the public | Press releases |
| Press Release November 2009 | PR Nov 2009 | Documents for the public | Press releases |
| Press Release November 2010 | PR Nov 2010 | Documents for the public | Press releases |
| Press Release November 2011 | PR Nov 2011 | Documents for the public | Press releases |
| Press Release November 2013 | PR Nov 2013 | Documents for the public | Press releases |
| Press Release November 2014 | PR Nov 2014 | Documents for the public | Press releases |
| Press Release November 2015 | PR Nov 2015 | Documents for the public | Press releases |
| Press Release October 2012 | PR Oct 2012 | Documents for the public | Press releases |
| Press Release October 2017 | PR October 2017 | Documents for the public | Press releases |
| Press Release October 2018 | PR October 2018 | Documents for the public | Press releases |
| Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects | PI 010-5 | Documents for Inspectorates | Inspectorates |
| Procedure on Notification of Foreign Inspections | PI 039-1 | Documents for Inspectorates | Inspectorates |
| Public Summary Version of PIC/S Road Map 2018-2020 | PS W 10 2018 | Documents for the public | Information documents |
| QA Distribution Activities for APIs – May 2010 | PS INF 20 2011 | Documents for Inspectors | Q&A Documents |
| QA on PIC/S GDP Guide (PE 011-1) | PS INF 22 2017 | Documents for Inspectors | Q&A Documents |
| QA on Traceability of Medicinal Gases | PS INF 06 2012 (Rev 1) | Documents for Inspectors | Q&A Documents |
| Quality System Requirements For Pharmaceutical Inspectorates | PI 002-3 | Documents for Inspectorates | Inspectorates |
| Questionnaire for Assessment | PS W 01 2011 (Rev. 1) | Documents for Inspectorates | Inspectorates |
| 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 |
| Recommendation on Sterility Testing | PI 012-3 | Documents for Inspectors | Guidance documents |
| 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 |
| Revised PIC/S Scheme | PICS 1/95 (Rev 6) | Documents for Inspectorates | Inspectorates |
| Site Master File (SMF) for Plasma Warehouses | PI 020-3 | Documents for Industry | Site Master Files |
| Site Master File (SMF) for Source Plasma Establishments | PI 019-3 | Documents for Industry | Site Master Files |
| Standard Operating Procedure PIC/S Inspection Report Format | PI 013-3 | Documents for Inspectorates | Inspectorates |
| Standard Operating Procedure Team Inspections | PI 031-1 | Documents for Inspectorates | Inspectorates |
| Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation | PI 006-3 | Documents for Inspectors | Guidance documents |
| Validation of Aseptic Processes | PI 007-6 | Documents for Inspectors | Guidance documents |
