| 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 |
