sop of Pharmaceutical Inspection Co-Operation scheme (PICS)
PIC/S GMP Guide
(Last updated by PIC/S Secretariat on 12 February 2016)
Documents for industry (PIC/S GMP Guide)
| PIC/S GMP GUIDE | PE 009-12 | Download |
| PIC/S GMP GUIDE (INTRODUCTION) | PE 009-12 | Download |
| PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) | PE 009-12 | Download |
| PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) | PE 009- | Download |
| PIC/S GMP GUIDE (ANNEXES) | PE 009-12 | Download |
| JOINT PIC/S-EMA CONCEPT PAPER ON THE REVISION OF ANNEX 1 | PS W 01 2015 | Download |
Documents for industry (Site Master Files)
| EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE | PE 008-4 | Download |
| SITE MASTER FILE FOR SOURCE PLASMA ESTABLISHMENTS | PI 019-3 | Download |
| SITE MASTER FILE FOR PLASMA WAREHOUSES | PI 020-3 | Download |
Documents for inspectors (Guidance documents)
| PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products | PE 011-1 | Download |
| PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS | PE 005-3 | Download |
| GUIDANCE ON PARAMETRIC RELEASE | PI 005-3 | Download |
| VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION | PI 006-3 | Download |
| VALIDATION OF ASEPTIC PROCESSES | PI 007-6 | Download |
| PIC/S GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE) | PI 008-3 | Download |
| GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS | PI 011-3 | Download |
| GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS (PE 010-4) | PE 010-4 | Download |
| RECOMMENDATION ON STERILITY TESTING | PI 012-3 | Download |
| ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING | PI 014-3 | Download |
| TECHNICAL INTERPRETATION OF REVISED ANNEX 1 TO PIC/S GMP GUIDE | PI 032-2 | Download |
| PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING | PI-037-1 | Download |
Documents for inspectors (Q&A Documents)
| QA DISTRIBUTION ACTIVITIES FOR APIs – MAY 2010 | PS INF 20 2011 | Download |
| QA ON TRACEABILITY OF MEDICINAL GASES | PS INF 06 2012 (Rev 1) | Download |
Documents for inspectorates
| PIC/S SCHEME | PICS 1/95 (Rev 5) | Download |
| PARTICIPATING AUTHORITIES | PS/INF 21/2002 (Rev 19) | Download |
| PIC CONVENTION | PIC Convention | Download |
| QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES | PI 002-3 | Download |
| PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS | PI 010-4 | Download |
| STANDARD OPERATING PROCEDURE PIC/S INSPECTION REPORT FORMAT | PI 013-3 | Download |
| STANDARD OPERATING PROCEDURE TEAM INSPECTIONS | PI 031-1 | Download |
| PROCEDURE ON NOTIFICATION OF FOREIGN INSPECTIONS | PI 039-1 | Download |
Documents for inspectors (Aide-Memoires)
| AIDE-MEMOIRE INSPECTION OF UTILITIES | PI 009-3 | Download |
| AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS | PI 021-2 | Download |
| AIDE MEMOIRE ON INSPECTION OF QUALITY CONTROL LABORATORIES | PI 023-2 | Download |
| AIDE MEMOIRE ON INSPECTION OF BIOTECH | PI 024-2 | Download |
| AIDE-MEMOIRE ON MEDICINAL GASES | PI 025-2 | Download |
| AIDE-MEMOIRE ON PACKAGING | PI 028-1 | Download |
| AIDE-MEMOIRE ON THE INSPECTION OF APIS | PI 030-1 | Download |
| AIDE MEMOIRE ON ASSESSMENT OF QRM IMPLEMENTATION | PI 038-1 | Download |
Documents for the public (Information documents)
| PIC/S FAQ (Frequently Asked Questions) | PS INF 18 2014 (Draft 1) | Download |
| PIC/S BROCHURE | January 2014 Edition | Download |
| PIC/S BLUEPRINT | PS W 8 2005 | Download |
Documents for the public (Miscelleneous)
| EXAMPLE OF QUALITY RISK MANAGEMENT IMPLEMENTATION | PS/INF 1/2010 | Download |
| JOINT WORKSHOP | PIC/S-PDA&ISPE | Download |
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