PIC/S [Pharmaceutical Inspection Convention and Pharmaceutical Inspection Scheme]- Guidelines & Links

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                        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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