Last update 02 December 2014
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Most PIC/S publications can be downloaded for free from this web page. Seminar booklets can also be purchased for CHF 40.- per item. To order, please click on the Buy Now button which will enable you to pay by credit card.

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

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  Document Reference Category Section    
PIC/S GMP GUIDE PE 009-11 Documents for industry PIC/S GMP Guide Download 2M
  SITE MASTER FILE FOR PLASMA WAREHOUSES PI 020-3 Documents for industry PIC/S GMP Guide Download 713K
  PIC/S GMP GUIDE (INTRODUCTION) PE 009-11 (Intro) Documents for industry PIC/S GMP Guide Download 213K
  PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) PE 009-11 (Part I) Documents for industry PIC/S GMP Guide Download 332K
  PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) PE 009-11 (Part II) Documents for industry PIC/S GMP Guide Download 517K
  PIC/S GMP GUIDE (ANNEXES) PE 009-11 (Annexes) Documents for industry PIC/S GMP Guide Download 1M
EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE PE 008-4 Documents for industry Site Master Files Download 250K
  SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS PI 019-3 Documents for industry Site Master Files Download 2M
  PIC/S SCHEME PICS 1/95 (Rev 5) Documents for inspectorates Inspectorates Download 80K
  PARTICIPATING AUTHORITIES & PARTNERS & (PRE)-APPLICANTS PS/INF 21/2002 (Rev 17) Documents for inspectorates Inspectorates Download 295K
  PIC CONVENTION PIC Convention Documents for inspectorates Inspectorates Download 104K
  QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES PI 002-3 Documents for inspectorates Inspectorates Download 130K
  PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS PI 010-4 Documents for inspectorates Inspectorates Download 116K
  STANDARD OPERATING PROCEDURE PIC/S INSPECTION REPORT FORMAT PI 013-3 Documents for inspectorates Inspectorates Download 108K
  STANDARD OPERATING PROCEDURE TEAM INSPECTIONS PI 031-1 Documents for inspectorates Inspectorates Download 93K
  QA DISTRIBUTION ACTIVITIES FOR APIs - MAY 2010 PS INF 20 2011 Documents for inspectors Q&A Documents Download 55K
  QA ON TRACEABILITY OF MEDICINAL GASES PS INF 06 2012 (Rev 1) Documents for inspectors Q&A Documents Download 146K
  AIDE-MEMOIRE INSPECTION OF UTILITIES PI 009-3 Documents for inspectors Aide-Memoires Download 109K
  AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS PI 021-2 Documents for inspectors Aide-Memoires Download 119K
  AIDE MEMOIRE ON INSPECTION OF QUALITY CONTROL LABORATORIES PI 023-2 Documents for inspectors Aide-Memoires Download 220K
  AIDE MEMOIRE ON INSPECTION OF BIOTECH PI 024-2 Documents for inspectors Aide-Memoires Download 163K
  AIDE-MEMOIRE ON MEDICINAL GASES PI 025-2 Documents for inspectors Aide-Memoires Download 135K
AIDE-MEMOIRE ON PACKAGING PI 028-1 Documents for inspectors Aide-Memoires Download 122K
AIDE-MEMOIRE ON THE INSPECTION OF APIS PI 030-1 Documents for inspectors Aide-Memoires Download 170K
  AIDE MEMOIRE ON ASSESSMENT OF QRM IMPLEMENTATION PI 038-1 Documents for inspectors Aide-Memoires Download 167K
  PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products PE 011-1 Documents for inspectors Guidance documents Download 196K
  PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS PE 005-3 Documents for inspectors Guidance documents Download 179K
  GUIDANCE ON PARAMETRIC RELEASE PI 005-3 Documents for inspectors Guidance documents Download 165K
  VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION PI 006-3 Documents for inspectors Guidance documents Download 227K
  VALIDATION OF ASEPTIC PROCESSES PI 007-6 Documents for inspectors Guidance documents Download 167K
  PIC/S GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE) PI 008-3 Documents for inspectors Guidance documents Download 298K
  GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS PI 011-3 Documents for inspectors Guidance documents Download 443K
  GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS (PE 010-4) PE 010-4 Documents for inspectors Guidance documents Download 217K
  RECOMMENDATION ON STERILITY TESTING PI 012-3 Documents for inspectors Guidance documents Download 159K
  ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING PI 014-3 Documents for inspectors Guidance documents Download 195K
  TECHNICAL INTERPRETATION OF REVISED ANNEX 1 TO PIC/S GMP GUIDE PI 032-2 Documents for inspectors Guidance documents Download 169K
  PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING PI-037-1 Documents for inspectors Guidance documents Download 131K
  PIC/S FAQ (Frequently Asked Questions) PS INF 18 2014 (Draft 1) Documents for the public Information documents Download 106K
  PIC/S BROCHURE January 2014 Edition Documents for the public Information documents Download 799K
PIC/S BLUEPRINT PS W 8 2005 Documents for the public Information documents Download 505K
PRESS RELEASE NOVEMBER 2014 PR Nov 2014 Documents for the public Press Releases Download 1M
PRESS RELEASE MAY 2014 PR May 2014 Documents for the public Press Releases Download 1M
PRESS RELEASE NOVEMBER 2013 PR Nov 2013 Documents for the public Press Releases Download 402K
PRESS RELEASE MAY 2013 PR May 2013 Documents for the public Press Releases Download 376K
PRESS RELEASE OCTOBER 2012 PR Oct 2012 Documents for the public Press Releases Download 356K
PRESS RELEASE MAY 2012 PR May 2012 Documents for the public Press Releases Download 104K
PRESS RELEASE NOVEMBER 2011 PR Nov 2011 Documents for the public Press Releases Download 112K
PRESS RELEASE NO 2 JUNE 2011 PR 02 Jun 2011 Documents for the public Press Releases Download 133K
PRESS RELEASE NO 1 JUNE 2011 PR 01 Jun 2011 Documents for the public Press Releases Download 43K
PRESS RELEASE NOVEMBER 2010 PR Nov 2010 Documents for the public Press Releases Download 156K
PRESS RELEASE MAY 2010 PR May 2010 Documents for the public Press Releases Download 148K
PRESS RELEASE NOVEMBER 2009 PR Nov 2009 Documents for the public Press Releases Download 138K
PRESS RELEASE MAY 2009 PR May 2009 Documents for the public Press Releases Download 129K
PRESS RELEASE NOVEMBER 2008 PR Nov 2008 Documents for the public Press Releases Download 115K
PRESS RELEASE MAY 2008 PR May 2008 Documents for the public Press Releases Download 122K
PRESS RELEASE NOVEMBER 2007 PR Nov 2007 Documents for the public Press Releases Download 121K
PRESS RELEASE MAY 2007 PR May 2007 Documents for the public Press Releases Download 106K
PRESS RELEASE DECEMBER 2006 PR Dec 2006 Documents for the public Press Releases Download 50K
PRESS RELEASE JUNE 2006 PR Jun 2006 Documents for the public Press Releases Download 51K
PRESS RELEASE FEBRUARY 2005 PR Feb 2005 Documents for the public Press Releases Download 106K
PRESS RELEASE JUNE 2004 PR Jun 2004 Documents for the public Press Releases Download 34K
PRESS RELEASE NOVEMBER 2003 PR Nov 2003 Documents for the public Press Releases Download 176K
PRESS RELEASE JUNE 2003 PR Jun 2003 Documents for the public Press Releases Download 147K
PRESS RELEASE MAY 2002 PR May 2002 Documents for the public Press Releases Download 44K
  ANNUAL REPORT 2013 AR 2013 Documents for the public Annual Reports Download 404K
  ANNUAL REPORT 2012 AR 2012 Documents for the public Annual Reports Download 349K
  ANNUAL REPORT 2011 AR 2011 Documents for the public Annual Reports Download 258K
  ANNUAL REPORT 2010 AR 2010 Documents for the public Annual Reports Download 146K
  ANNUAL REPORT 2009 AR 2009 Documents for the public Annual Reports Download 181K
  ANNUAL REPORT 2008 AR 2008 Documents for the public Annual Reports Download 175K
  ANNUAL REPORT 2007 AR 2007 Documents for the public Annual Reports Download 179K
  ANNUAL REPORT 2006 AR 2006 Documents for the public Annual Reports Download 181K
  ANNUAL REPORT 2005 AR 2005 Documents for the public Annual Reports Download 195K
  ANNUAL REPORT 2004 AR 2004 Documents for the public Annual Reports Download 187K
  ANNUAL REPORT 2003 AR 2003 Documents for the public Annual Reports Download 58K
  ANNUAL REPORT 2002 AR 2002 Documents for the public Annual Reports Download 496K
  ANNUAL REPORT 2001 AR 2001 Documents for the public Annual Reports Download 134K
  ANNUAL REPORT 2000 AR 2000 Documents for the public Annual Reports Download 131K
  ANNUAL REPORT 1999 AR 1999 Documents for the public Annual Reports Download 101K
EXAMPLE OF QUALITY RISK MANAGEMENT IMPLEMENTATION PS/INF 1/2010 Documents for the public Miscelleneous Download 5M
JOINT WORKSHOP PIC/S-PDA&ISPE Documents for the public Miscelleneous Download 1M

Last updated by PIC/S Secretariat on 02 December 2014


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PIC/S Secretariat 14, rue du Roveray CH - 1207 Geneva Switzerland
Tel.: (+41) 22 738 92 16 - Fax: (+41) 22 738 92 17 - E-mail

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