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PIC/S - The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme


Learn and download latest PIC/S Guidelines for current Good Manufacturing Practices.
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 market complaint, product recall etc.
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme guidelines are applicable for the member countries

Document
Reference
Category
Section

PIC/S GMP GUIDE PE 009-11
Documents for Industry
GMP Guide
PIC/S GMP GUIDE (INTRODUCTION) PE 009-11 (Intro)
Documents for Industry
GMP Guide
PIC/S GMP GUIDE (PART I: BASIC REQUIREMENTS FOR MEDICINAL PRODUCTS) PE 009-11 (Part I)
Documents for Industry
GMP Guide
PIC/S GMP GUIDE (PART II: BASIC REQUIREMENTS FOR ACTIVE PHARMACEUTICAL INGREDIENTS) PE 009-11 (Part II)
Documents for Industry
GMP Guide
PIC/S GMP GUIDE (ANNEXES) PE 009-11 (Annexes)
Documents for Industry
GMP Guide
JOINT PIC/S-EMA CONCEPT PAPER ON THE REVISION OF ANNEX 1 PS W 01 2015
Documents for Industry
GMP Guide
Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File
PE 008-4
Documents for Industry
Site Master Files
Site Master File for Source Plasma Establishments
PI 019-3
Documents for Industry
Site Master Files
Site Master File for Plasma Warehouses
PI 020-3
Documents for Industry
Site Master Files
PIC/S Scheme
PICS 1/95 (Rev. 5)
Document for Inspectorates
Inspectorates
Participating Authorities & Partners
PS/INF 21/2002 (Rev. 15)
Document for Inspectorates
Inspectorates
PIC Convention
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Document for Inspectorates
Inspectorates
Quality System Requirements for Pharmaceutical Inspectorates
PI 002-3
Document for Inspectorates
Inspectorates
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects
PI 010-4
Document for Inspectorates
Inspectorates
Standard Operating Procedure PIC/S Inspection Report Format
PI 013-3
Document for Inspectorates
Inspectorates
Standard Operating Procedure Team Inspections
PI 031-1
Document for Inspectorates
Inspectorates
Aide-Memoire Inspection of Utilities
PI 009-3
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 Quality Control Laboratories
PI 023-2
Documents for Inspectors
Aide-Memoires
Aide Memoire on Inspection of Biotech
PI 024-2
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 APIS
PI 030-1
Documents for Inspectors
Aide-Memoires
Aide-Memoire on Assessment of Quality Risk Management Implementation
PI 038-1
Documents for Inspectors
Aide-Memoires
Questions & Answers document regarding Distribution Activities for Active Pharmaceutical Ingredients (APIs)
PS/INF 20/2011
Documents for Inspectors
Q&A Documents
Questions & Answers document regarding Traceability of Medicinal Gases
PS/INF 06/2012 (Rev 1)
Documents for Inspectors
Q&A Documents
PIC/S GMP Guide for Blood Establishments
PE 005-3
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 Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments
PE 010-3
Documents for Inspectors
Guidance documents
Guidance on Parametric Release
PI 005-3
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
Good Practices for Computerised Systems in Regulated "GxP" Environments
PI 011-3
Documents for Inspectors
Guidance documents
Recommendation on Sterility Testing
PI 012-3
Documents for Inspectors
Guidance documents
Isolators Used for Aseptic Processing and Sterility Testing
PI 014-3
Documents for Inspectors
Guidance documents
Technical Interpretation of Revised Annex 1 To PIC/S GMP Guide
PI 032-1
Documents for Inspectors
Guidance documents
A Recommended Model for Risk-Based Inspection Planning in the GMP Environment
PI 037-1
Documents for Inspectors
Guidance documents
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


2 Comments so far : Add yours...

Fred Marshall said...

Nice information, many thanks to the author. It is incomprehensible to me now, but in general, the usefulness and significance is overwhelming. Thanks again and good luck!


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Anthony Morris said...

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