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List of PIC/S Publications |
| Document | Reference | Category | Section | |
| PIC/S GMP Guide | PE 009-10 | Documents for Industry | GMP Guide | Download |
| Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File | PE 008-4 | Documents for Industry | Site Master Files | Download |
| Site Master File for Source Plasma Establishments | PI 019-3 | Documents for Industry | Site Master Files | Download |
| Site Master File for Plasma Warehouses | PI 020-3 | Documents for Industry | Site Master Files | Download |
| PIC/S Scheme | PICS 1/95 (Rev. 5) | Document for Inspectorates | Inspectorates | Download |
| Participating Authorities & Partners | PS/INF 21/2002 (Rev. 15) | Document for Inspectorates | Inspectorates | Download |
| PIC Convention | --- | Document for Inspectorates | Inspectorates | Download |
| Quality System Requirements for Pharmaceutical Inspectorates | PI 002-3 | Document for Inspectorates | Inspectorates | Download |
| Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects | PI 010-4 | Document for Inspectorates | Inspectorates | Download |
| Standard Operating Procedure PIC/S Inspection Report Format | PI 013-3 | Document for Inspectorates | Inspectorates | Download |
| Standard Operating Procedure Team Inspections | PI 031-1 | Document for Inspectorates | Inspectorates | Download |
| Aide-Memoire Inspection of Utilities | PI 009-3 | Documents for Inspectors | Aide-Memoires | Download |
| Aide Memoire on GMP Particularities for Clinical Trial Products | PI 021-2 | Documents for Inspectors | Aide-Memoires | Download |
| Aide Memoire on Inspection of Quality Control Laboratories | PI 023-2 | Documents for Inspectors | Aide-Memoires | Download |
| Aide Memoire on Inspection of Biotech | PI 024-2 | Documents for Inspectors | Aide-Memoires | Download |
| Aide-Memoire on Medicinal Gases | PI 025-2 | Documents for Inspectors | Aide-Memoires | Download |
| Aide-Memoire on Packaging | PI 028-1 | Documents for Inspectors | Aide-Memoires | Download |
| Aide-Memoire on The Inspection of APIS | PI 030-1 | Documents for Inspectors | Aide-Memoires | Download |
| Aide-Memoire on Assessment of Quality Risk Management Implementation | PI 038-1 | Documents for Inspectors | Aide-Memoires | Download |
| Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs) | PS/INF 20/2011 | Documents for Inspectors | Q&A Documents | Download |
| Questions & Answers document regarding Traceability of Medicinal Gases | PS/INF 06/2012 (Rev 1) | Documents for Inspectors | Q&A Documents | Download |
| PIC/S GMP Guide for Blood Establishments | PE 005-3 | Documents for Inspectors | Guidance documents | Download |
| PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (Inspection Guide) | PI 008-3 | Documents for Inspectors | Guidance documents | Download |
| PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments | PE 010-3 | Documents for Inspectors | Guidance documents | Download |
| Guidance on Parametric Release | PI 005-3 | Documents for Inspectors | Guidance documents | Download |
| Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation | PI 006-3 | Documents for Inspectors | Guidance documents | Download |
| Validation of Aseptic Processes | PI 007-6 | Documents for Inspectors | Guidance documents | Download |
| Good Practices for Computerised Systems in Regulated "GxP" Environments | PI 011-3 | Documents for Inspectors | Guidance documents | Download |
| Recommendation on Sterility Testing | PI 012-3 | Documents for Inspectors | Guidance documents | Download |
| Isolators Used for Aseptic Processing and Sterility Testing | PI 014-3 | Documents for Inspectors | Guidance documents | Download |
| Technical Interpretation of Revised Annex 1 To PIC/S GMP Guide | PI 032-1 | Documents for Inspectors | Guidance documents | Download |
| A Recommended Model for Risk-Based Inspection Planning in the GMP Environment | PI 037-1 | Documents for Inspectors | Guidance documents | Download |
| PIC/S Brochure | --- | Documents for the Public | Information documents | Download |
| PIC/S Blueprint | PS/W 8/2005 | Documents for the Public | Information documents | Download |
| Press Release October 2012 | PR Oct 2012 | Documents for the Public | Press Releases | Download |
| Press Release May 2012 | PR May 2012 | Documents for the Public | Press Releases | Download |
| Press Release November 2011 | PR Nov 2011 | Documents for the Public | Press Releases | Download |
| Press Release no 2 June 2011 | PR 02 June 2011 | Documents for the Public | Press Releases | Download |
| Press Release no 1 June 2011 | PR 01 June 2011 | Documents for the Public | Press Releases | Download |
| Press Release November 2010 | PR Nov 2010 | Documents for the Public | Press Releases | Download |
| Press Release May 2010 | PR May 2010 | Documents for the Public | Press Releases | Download |
| Press Release November 2009 | PR Nov 2009 | Documents for the Public | Press Releases | Download |
| Press Release May 2009 | PR May 2009 | Documents for the Public | Press Releases | Download |
| Press Release November 2008 | PR Nov 2008 | Documents for the Public | Press Releases | Download |
| Press Release May 2008 | PR May 2008 | Documents for the Public | Press Releases | Download |
| Press Release November 2007 | PR Nov 2007 | Documents for the Public | Press Releases | Download |
| Press Release May 2007 | PR May 2007 | Documents for the Public | Press Releases | Download |
| Press Release December 2006 | PR Dec 2006 | Documents for the Public | Press Releases | Download |
| Press Release June 2006 | PR Jun 2006 | Documents for the Public | Press Releases | Download |
| Press Release February 2005 | PR Feb 2005 | Documents for the Public | Press Releases | Download |
| Press Release June 2004 | PR Jun 2004 | Documents for the Public | Press Releases | Download |
| Press Release November 2003 | PR Nov 2003 | Documents for the Public | Press Releases | Download |
| Press Release June 2003 | PR Jun 2003 | Documents for the Public | Press Releases | Download |
| Press Release May 2002 | PR May 2002 | Documents for the Public | Press Releases | Download |
| Annual Report 1999 | AR 1999 | Documents for the Public | Annual Reports | Download |
| Annual Report 2000 | AR 2000 | Documents for the Public | Annual Reports | Download |
| Annual Report 2001 | AR 2001 | Documents for the Public | Annual Reports | Download |
| Annual Report 2002 | AR 2002 | Documents for the Public | Annual Reports | Download |
| Annual Report 2003 | AR 2003 | Documents for the Public | Annual Reports | Download |
| Annual Report 2004 | AR 2004 | Documents for the Public | Annual Reports | Download |
| Annual Report 2005 | AR 2005 | Documents for the Public | Annual Reports | Download |
| Annual Report 2006 | AR 2006 | Documents for the Public | Annual Reports | Download |
| Annual Report 2007 | AR 2007 | Documents for the Public | Annual Reports | Download |
| Annual Report 2008 | AR 2008 | Documents for the Public | Annual Reports | Download |
| Annual Report 2009 | AR 2009 | Documents for the Public | Annual Reports | Download |
| Annual Report 2010 | AR 2010 | Documents for the Public | Annual Reports | Download |
| Annual Report 2011 | AR 2011 | Documents for the Public | Annual Reports | Download |
| PIC/S-PDA & ISPE Joint Workshop | --- | Documents for the Public | Miscellaneous | Download |
| Example of Quality Risk Management Implementation | PS/INF 01/2010 | Documents for the Public | Miscellaneous | Download |
| Reset | ||||||
| Document | Reference | Category | Section | |||
| PIC/S GMP GUIDE | PE 009-10 | Download | ||||
| PIC/S GMP GUIDE (INTRODUCTION) | PE 009-10 (Intro) | Download | ||||
| PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) | PE 009-10 (Part I) | Download | ||||
| PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) | PE 009-10 (Part II) | Download | ||||
| PIC/S GMP GUIDE (ANNEXES) | PE 009-10 (Annexes) | Download | ||||
Last updated by PIC/S Secretariat on 11 December 2012
