PIC/S is The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme that provides the pharmaceuticals GMP guidelines for industries. Mainly they provide guidelines for sterile pharmaceutical guidelines.
They also provide quality assurance guidelines as the market complaint, product recalls etc.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme guidelines are applicable for the member countries
They also provide quality assurance guidelines as the market complaint, product recalls etc.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme guidelines are applicable for the member countries
Document
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Reference
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Category
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Section
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| PIC/S GMP GUIDE | PE 009-11 |
Documents for Industry
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GMP Guide
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| PIC/S GMP GUIDE (INTRODUCTION) | PE 009-11 (Intro) |
Documents for Industry
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GMP Guide
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| PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) | PE 009-11 (Part I) |
Documents for Industry
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GMP Guide
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| PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) | PE 009-11 (Part II) |
Documents for Industry
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GMP Guide
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| PIC/S GMP GUIDE (ANNEXES) | PE 009-11 (Annexes) |
Documents for Industry
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GMP Guide
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| JOINT PIC/S-EMA CONCEPT PAPER ON THE REVISION OF ANNEX 1 | PS W 01 2015 |
Documents for Industry
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GMP Guide
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Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File
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PE 008-4
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Documents for Industry
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Site Master Files
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Site Master File for Source Plasma Establishments
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PI 019-3
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Documents for Industry
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Site Master Files
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Site Master File for Plasma Warehouses
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PI 020-3
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Documents for Industry
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Site Master Files
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PIC/S Scheme
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PICS 1/95 (Rev. 5)
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Document for Inspectorates
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Inspectorates
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Participating Authorities & Partners
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PS/INF 21/2002 (Rev. 15)
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Document for Inspectorates
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Inspectorates
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PIC Convention
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Document for Inspectorates
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Inspectorates
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Quality System Requirements for Pharmaceutical Inspectorates
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PI 002-3
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Document for Inspectorates
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Inspectorates
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Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
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PI 010-4
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Document for Inspectorates
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Inspectorates
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Standard Operating Procedure PIC/S Inspection Report Format
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PI 013-3
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Document for Inspectorates
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Inspectorates
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Standard Operating Procedure Team Inspections
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PI 031-1
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Document for Inspectorates
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Inspectorates
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Aide-Memoire Inspection of Utilities
|
PI 009-3
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Documents for Inspectors
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Aide-Memoires
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Aide Memoire on GMP Particularities for Clinical Trial Products
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PI 021-2
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Documents for Inspectors
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Aide-Memoires
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Aide Memoire on Inspection of Quality Control Laboratories
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PI 023-2
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Documents for Inspectors
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Aide-Memoires
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Aide Memoire on Inspection of Biotech
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PI 024-2
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Documents for Inspectors
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Aide-Memoires
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Aide-Memoire on Medicinal Gases
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PI 025-2
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Documents for Inspectors
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Aide-Memoires
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Aide-Memoire on Packaging
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PI 028-1
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Documents for Inspectors
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Aide-Memoires
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Aide-Memoire on The Inspection of APIS
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PI 030-1
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Documents for Inspectors
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Aide-Memoires
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Aide-Memoire on Assessment of Quality Risk Management Implementation
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PI 038-1
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Documents for Inspectors
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Aide-Memoires
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Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs)
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PS/INF 20/2011
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Documents for Inspectors
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Q&A Documents
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Questions & Answers document regarding Traceability of Medicinal Gases
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PS/INF 06/2012 (Rev 1)
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Documents for Inspectors
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Q&A Documents
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PIC/S GMP Guide for Blood Establishments
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PE 005-3
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Documents for Inspectors
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Guidance documents
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PIC/S Guide to Inspections of Source Plasma Establishments and Plasma Warehouses (Inspection Guide)
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PI 008-3
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Documents for Inspectors
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Guidance documents
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PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
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PE 010-3
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Documents for Inspectors
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Guidance documents
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Guidance on Parametric Release
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PI 005-3
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Documents for Inspectors
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Guidance documents
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Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation
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PI 006-3
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Documents for Inspectors
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Guidance documents
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Validation of Aseptic Processes
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PI 007-6
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Documents for Inspectors
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Guidance documents
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Good Practices for Computerised Systems in Regulated "GxP" Environments
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PI 011-3
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Documents for Inspectors
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Guidance documents
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Recommendation on Sterility Testing
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PI 012-3
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Documents for Inspectors
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Guidance documents
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Isolators Used for Aseptic Processing and Sterility Testing
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PI 014-3
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Documents for Inspectors
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Guidance documents
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Technical Interpretation of Revised Annex 1 To PIC/S GMP Guide
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PI 032-1
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Documents for Inspectors
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Guidance documents
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A Recommended Model for Risk-Based Inspection Planning in the GMP Environment
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PI 037-1
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Documents for Inspectors
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Guidance documents
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