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| Document | Reference | Category | Section | |||
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PIC/S GMP GUIDE | PE 009-10 | Documents for industry | PIC/S GMP Guide | Download | 1M |
| PIC/S GMP GUIDE (INTRODUCTION) | PE 009-10 (Intro) | Documents for industry | PIC/S GMP Guide | Download | 124K | |
| PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) | PE 009-10 (Part I) | Documents for industry | PIC/S GMP Guide | Download | 304K | |
| PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) | PE 009-10 (Part II) | Documents for industry | PIC/S GMP Guide | Download | 411K | |
| PIC/S GMP GUIDE (ANNEXES) | PE 009-10 (Annexes) | Documents for industry | PIC/S GMP Guide | Download | 964K | |
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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 | |
| SITE MASTER FILE FOR PLASMA WAREHOUSES | PI 020-3 | Documents for industry | Site Master Files | Download | 845K | |
| PIC/S SCHEME | PICS 1/95 (Rev 5) | Documents for inspectorates | Inspectorates | Download | 80K | |
| PARTICIPATING AUTHORITIES & PARTNERS | PS/INF 21/2002 (Rev 15) | Documents for inspectorates | Inspectorates | Download | 135K | |
| 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 | |
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AIDE-MEMOIRE ON PACKAGING | PI 028-1 | Documents for inspectors | Aide-Memoires | Download | 122K |
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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 GMP GUIDE FOR BLOOD ESTABLISHMENTS | PE 005-3 | Documents for inspectors | Guidance documents | Download | 179K | |
| GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS (PE 010-3) | PE 010-3 | Documents for inspectors | Guidance documents | Download | 356K | |
| 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 | |
| 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 | |
| MAY 2011 EDITION | PIC/S BROCHURE | Documents for the public | Information documents | Download | 680K | |
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PIC/S BLUEPRINT | PS W 8 2005 | Documents for the public | Information documents | Download | 505K |
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PRESS RELEASE OCTOBER 2012 | PR Oct 2012 | Documents for the public | Press Releases | Download | 356K |
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PRESS RELEASE MAY 2012 | PR May 2012 | Documents for the public | Press Releases | Download | 104K |
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PRESS RELEASE NOVEMBER 2011 | PR Nov 2011 | Documents for the public | Press Releases | Download | 112K |
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PRESS RELEASE NO 2 JUNE 2011 | PR 02 Jun 2011 | Documents for the public | Press Releases | Download | 133K |
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PRESS RELEASE NO 1 JUNE 2011 | PR 01 Jun 2011 | Documents for the public | Press Releases | Download | 43K |
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PRESS RELEASE NOVEMBER 2010 | PR Nov 2010 | Documents for the public | Press Releases | Download | 156K |
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PRESS RELEASE MAY 2010 | PR May 2010 | Documents for the public | Press Releases | Download | 148K |
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PRESS RELEASE NOVEMBER 2009 | PR Nov 2009 | Documents for the public | Press Releases | Download | 138K |
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PRESS RELEASE MAY 2009 | PR May 2009 | Documents for the public | Press Releases | Download | 129K |
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PRESS RELEASE NOVEMBER 2008 | PR Nov 2008 | Documents for the public | Press Releases | Download | 115K |
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PRESS RELEASE MAY 2008 | PR May 2008 | Documents for the public | Press Releases | Download | 122K |
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PRESS RELEASE NOVEMBER 2007 | PR Nov 2007 | Documents for the public | Press Releases | Download | 121K |
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PRESS RELEASE MAY 2007 | PR May 2007 | Documents for the public | Press Releases | Download | 106K |
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PRESS RELEASE DECEMBER 2006 | PR Dec 2006 | Documents for the public | Press Releases | Download | 50K |
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PRESS RELEASE JUNE 2006 | PR Jun 2006 | Documents for the public | Press Releases | Download | 51K |
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PRESS RELEASE FEBRUARY 2005 | PR Feb 2005 | Documents for the public | Press Releases | Download | 106K |
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PRESS RELEASE JUNE 2004 | PR Jun 2004 | Documents for the public | Press Releases | Download | 34K |
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PRESS RELEASE NOVEMBER 2003 | PR Nov 2003 | Documents for the public | Press Releases | Download | 176K |
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PRESS RELEASE JUNE 2003 | PR Jun 2003 | Documents for the public | Press Releases | Download | 147K |
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PRESS RELEASE MAY 2002 | PR May 2002 | Documents for the public | Press Releases | Download | 44K |
| 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 | |
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EXAMPLE OF QUALITY RISK MANAGEMENT IMPLEMENTATION | PS/INF 1/2010 | Documents for the public | Miscelleneous | Download | 5M |
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JOINT WORKSHOP | PIC/S-PDA&ISPE | Documents for the public | Miscelleneous | Download | 1M |
Last updated by PIC/S Secretariat on 17 June 2013
