PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links
| All | Reference | Category | Section |
| AIDE MEMOIRE ON ASSESSMENT OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION | PI 038-1 | Documents for Inspectors | Aide-Memoires |
| AIDE MEMOIRE ON GMP PARTICULARITIES FOR CLINICAL TRIAL PRODUCTS | PI 021-2 | Documents for Inspectors | Aide-Memoires |
| AIDE MEMOIRE ON INSPECTION OF BIOTECH | PI 024-2 | Documents for Inspectors | Aide-Memoires |
| AIDE MEMOIRE ON INSPECTION OF QUALITY CONTROL LABORATORIES | PI 023-2 | Documents for Inspectors | Aide-Memoires |
| AIDE-MEMOIRE INSPECTION OF UTILITIES | PI 009-3 | Documents for Inspectors | Aide-Memoires |
| AIDE-MEMOIRE ON MEDICINAL GASES | PI 025-2 | Documents for Inspectors | Aide-Memoires |
| AIDE-MEMOIRE ON PACKAGING | PI 028-1 | Documents for Inspectors | Aide-Memoires |
| AIDE-MEMOIRE ON THE INSPECTION OF ACTIVE PHARMACEUTIAL INGREDIENTS (APIS) | PI 030-1 | Documents for Inspectors | Aide-Memoires |
| CONSULTATION DOCUMENT ON ANNEX 1 (MANUFACTURE OF STERILE MEDICINAL PRODUCTS) | Consultation Document on Revision of Annex 1 | Documents for Industry | PIC/S GMP Guide |
| DRAFT PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS | PI 041-1 (Draft 2) | Documents for Inspectors | Guidance documents |
| EXAMPLE OF QUALITY RISK MANAGEMENT (QRM) IMPLEMENTATION | PS/INF 1/2010 | Documents for the public | Miscellaneous |
| EXPLANATORY NOTES FOR PHARMACEUTICAL MANUFACTURERS ON THE PREPARATION OF A SITE MASTER FILE (SMF) | PE 008-4 | Documents for Industry | Site Master Files |
| GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED GXP ENVIRONMENTS | PI 011-3 | Documents for Inspectors | Guidance documents |
| GUIDANCE ON GMP INSPECTION RELIANCE | PI 048-1 | Documents for Inspectorates | Inspectorates |
| GUIDANCE ON PARAMETRIC RELEASE | PI 005-3 | Documents for Inspectors | Guidance documents |
| GUIDE TO GOOD PRACTICES FOR THE PREPARATION OF MEDICINAL PRODUCTS IN HEALTHCARE ESTABLISHMENTS | PE 010-4 | Documents for Inspectors | Guidance documents |
| ISOLATORS USED FOR ASEPTIC PROCESSING AND STERILITY TESTING | PI 014-3 | Documents for Inspectors | Guidance documents |
| JOINT PIC/S-EMA CONCEPT PAPER ON THE REVISION OF ANNEX 1 (MANUFACTURE OF STERILE MEDICINAL PRODUCTS) | PS W 01 2015 | Documents for Industry | PIC/S GMP Guide |
| NON-TECHNICAL ASPECTS OF INSPECTION (PIC/S SEMINAR 1999 BOOKLET) | PS INF 72 2000 | Documents for the public | Information documents |
| PARTICIPATING AUTHORITIES | PS/INF 21/2002 (Rev. 23) | Documents for Inspectorates | Inspectorates |
| PIC CONVENTION OF 1970 | PIC Convention | Documents for Inspectorates | Inspectorates |
| PIC/S AUDIT CHECKLIST | PS W 01 2005 (Rev 2) | Documents for Inspectorates | Inspectorates |
| PIC/S BLUEPRINT | PS W 8 2005 | Documents for the public | Information documents |
| PIC/S BROCHURE 2016 | Brochure | Documents for the public | Information documents |
| PIC/S GMP GUIDE (INTRODUCTION) | PE 009-13 (Intro) | Documents for Industry | PIC/S GMP Guide |
| PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) | PE 009-13 (Part I) | Documents for Industry | PIC/S GMP Guide |
| PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) | PE 009-13 (Part II) | Documents for Industry | PIC/S GMP Guide |
| PIC/S GMP GUIDE (RELATED ANNEXES) | PE 009-13 (Annexes) | Documents for Industry | PIC/S GMP Guide |
| PIC/S GMP GUIDE (ZIP) | PE 009-13 | Documents for Industry | PIC/S GMP Guide |
| PIC/S GMP GUIDE FOR BLOOD ESTABLISHMENTS | PE 005-3 | Documents for Inspectors | Guidance documents |
| PIC/S GUIDE TO GOOD DISTRIBUTION PRACTICE (GDP) FOR MEDICINAL PRODUCTS | PE 011-1 | Documents for Inspectors | Guidance documents |
| PIC/S GUIDE TO INSPECTIONS OF SOURCE PLASMA ESTABLISHMENTS AND PLASMA WAREHOUSES (INSPECTION GUIDE) | PI 008-3 | Documents for Inspectors | Guidance documents |
| PIC/S GUIDELINES FOR ACCESSION | PS W 14 2011 (Rev. 1) | Documents for Inspectorates | Inspectorates |
| PIC/S LETTER OF AGREEMENT WITH EUROPEAN ECONOMIC AREA (EEA) HEADS OF MEDICINES AGENCIES (HMA) | PS/W 18/2016 | Documents for Inspectorates | Inspectorates |
| PIC/S RECOMMENDATION ON RISK-BASED INSPECTION PLANNING | PI 037-1 | Documents for Inspectors | Guidance documents |
| PIC/S SCHEME | PICS 1/95 (Rev 5) | Documents for Inspectorates | Inspectorates |
| PROCEDURE FOR HANDLING RAPID ALERTS AND RECALLS ARISING FROM QUALITY DEFECTS | PI 010-5 | Documents for Inspectorates | Inspectorates |
| PROCEDURE ON NOTIFICATION OF FOREIGN INSPECTIONS | PI 039-1 | Documents for Inspectorates | Inspectorates |
| QA DISTRIBUTION ACTIVITIES FOR APIS – MAY 2010 | PS INF 20 2011 | Documents for Inspectors | Q&A Documents |
| QA ON TRACEABILITY OF MEDICINAL GASES | PS INF 06 2012 (Rev 1) | Documents for Inspectors | Q&A Documents |
| QUALITY SYSTEM REQUIREMENTS FOR PHARMACEUTICAL INSPECTORATES | PI 002-3 | Documents for Inspectorates | Inspectorates |
| QUESTIONNAIRE FOR ASSESSMENT | PS W 01 2011 | Documents for Inspectorates | Inspectorates |
| RECOMMENDATION ON STERILITY TESTING | PI 012-3 | Documents for Inspectors | Guidance documents |
| SITE MASTER FILE (SMF) FOR PLASMA WAREHOUSES | PI 020-3 | Documents for Industry | Site Master Files |
| SITE MASTER FILE (SMF) FOR SOURCE PLASMA ESTABLISHMENTS | PI 019-3 | Documents for Industry | Site Master Files |
| STANDARD OPERATING PROCEDURE PIC/S INSPECTION REPORT FORMAT | PI 013-3 | Documents for Inspectorates | Inspectorates |
| STANDARD OPERATING PROCEDURE TEAM INSPECTIONS | PI 031-1 | Documents for Inspectorates | Inspectorates |
| TECHNICAL INTERPRETATION OF REVISED ANNEX 1 TO PIC/S GMP GUIDE | PI 032-2 | Documents for Inspectors | Guidance documents |
| VALIDATION MASTER PLAN INSTALLATION AND OPERATIONAL QUALIFICATION NON-STERILE PROCESS VALIDATION CLEANING VALIDATION | PI 006-3 | Documents for Inspectors | Guidance documents |
| VALIDATION OF ASEPTIC PROCESSES | PI 007-6 | Documents for Inspectors | Guidance documents |
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