Publications (original) (raw)

PIC/S Aide Memoire on Remote Assessment

PI 057-1

Documents for Inspectors

Guidance documents

PIC/S Guidance on Remote Assessments

PI 056-1

Documents for Inspectors

Guidance documents

PIC/S Guidelines for Accession

PS W 14 2011 (Rev. 4)

Documents for Inspectorates

Inspectorates

PIC/S Guidelines for the Pre-Accession Procedure

PS W 12 2019 (Rev. 2)

Documents for Inspectorates

Inspectorates

Annual Report 2023

AR 2023

Documents for the public

Annual reports

Job Description for PIC/S Secretary / Executive Director

PS ADM 3 2024

Documents for the public

Information documents

PIC/S Brochure 2023

Brochure

Documents for the public

Information documents

Participating Authorities

PS/INF 21/2002 (Rev. 28)

Documents for Inspectorates

Inspectorates

Annual Report 2022

AR 2022

Documents for the public

Annual reports

PIC/S GMP Guide (PE 009-17) Introduction

PE 009-17 (Intro)

Documents for Industry

PIC/S GMP Guide

PIC/S GMP Guide (PE 009-17) Part I

PE 009-17 (Part I)

Documents for Industry

PIC/S GMP Guide

PIC/S GMP Guide (PE 009-17) Part II

PE 009-17 (Part II)

Documents for Industry

PIC/S GMP Guide

PIC/S GMP Guide (PE 009-17) Annexes

PE 009-17 (Annexes)

Documents for Industry

PIC/S GMP Guide

PIC/S Work Plan for 2023

PS W 03 2023

Documents for the public

Information documents

PIC/S Aide Memoire Inspection of GDP for Medicinal Products in the Supply Chain

PI 044-1

Documents for Inspectors

Guidance documents

QA on PIC/S GDP Guide (PE 011-1)

PS INF 22 2017

Documents for Inspectors

Q&A Documents

Concept Paper on the Revision of Annex 11 of the Guidelines on Good Manufacturing Practice for Medicinal Products | Computerised Systems

Concept Paper on the Revision of EU-PIC/S GMP Annex 11

Documents for Industry

PIC/S GMP Guide

2023-2027 PIC/S Strategic Plan

PS W 15 2022

Documents for the public

Information documents

PIC/S Work Plan for 2022

PS W 13 2022

Documents for the public

Information documents

Questionnaire for Assessment

PS W 01 2011 (Rev. 1)

Documents for Inspectorates

Inspectorates

PIC/S Audit Checklist

PS W 01 2005 (Rev. 3)

Documents for Inspectorates

Inspectorates

Annual Report 2021

AR 2021

Documents for the public

Annual reports

Concept Paper on the Revision of Annex 5 of the Guidelines on Good Manufacturing Practice for Medicinal Products | Manufacture of Immunological Veterinary Medicinal Products

Concept Paper on the Revision of EU-PIC/S GMP Annex 5

Documents for Industry

PIC/S GMP Guide

Concept Paper on the Revision of Annex 4 of the Guidelines on Good Manufacturing Practice | Manufacture of Veterinary Medicinal Products other than Immunologicals

Concept Paper on the Revision of EU-PIC/S GMP Annex 4

Documents for Industry

PIC/S GMP Guide

Annual Report 2020

AR 2020

Documents for the public

Annual reports

PIC/S Guidance COVID-19 Risk Assessment for Routine On-Site Inspections

PI 055-1

Documents for Inspectors

Guidance documents

PIC/S Recommendation How to Evaluate and Demonstrate the Effectiveness of the Pharmaceutical Quality System with regard to Risk-Based Change Management

PI 054-1

Documents for Inspectors

Guidance documents

PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

PI 041-1

Documents for Inspectors

Guidance documents

PIC/S Aide Memoire to Inspections of Blood Establishments and Plasma Warehouses

PI 008-4

Documents for Inspectors

Aide-Memoires

PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks

PE 005-4

Documents for Inspectors

Guidance documents

PIC/S Work Plan for 2021

PS W 01 2021

Documents for the public

Information documents

Aide Memoire on Assessment of Quality Risk Management (QRM) Implementation

PI 038-2

Documents for Inspectors

Aide-Memoires

Aide-Memoire on Packaging

PI 028-2

Documents for Inspectors

Aide-Memoires

Aide Memoire on Inspection of Biotech

PI 024-3

Documents for Inspectors

Aide-Memoires

Aide-Memoire Inspection of Utilities

PI 009-4

Documents for Inspectors

Aide-Memoires

PIC/S Audit Checklist - Interpretation Guide

PS W 31 2019

Documents for Inspectorates

Inspectorates

Annual Report 2019

AR 2019

Documents for the public

Annual reports

Questions and Answers (Q&A) on the Implementation of Risk-Based Prevention of Cross-Contamination in Production and ‘Guideline on Setting Health-Based Exposure Limits (HBEL) for Use in Risk Identification in the Manufacture of Different Medicinal Products in Shared Facilities’

PI 053-1

Documents for Inspectors

Guidance documents

Aide Memoire on the Inspection of Health Based Exposure Limit (HBEL) Assessments and Use in Quality Risk Management

PI 052-1

Documents for Inspectors

Guidance documents

Revised PIC/S Scheme

PICS 1/95 (Rev 6)

Documents for Inspectorates

Inspectorates

PIC/S Work Plan for 2020

PS W 37 2020

Documents for the public

Information documents

Press Release December 2019

PR December 2019

Documents for the public

Press releases

PIA Brochure 2019

Brochure

Documents for the public

Information documents

Annual Report 2018

AR 2018

Documents for the public

Annual reports

Press Release May 2019

PR May 2019

Documents for the public

Press releases

Guidance on Classification of GMP Deficiencies

PI 040-1

Documents for Inspectors

Guidance documents

PIC/S Work Plan for 2019

PS W 18 2018

Documents for the public

Information documents

Press Release October 2018

PR October 2018

Documents for the public

Press releases

Aide-Memoire on Cross-Contamination in Shared Facilities

PI 043-1

Documents for Inspectors

Aide-Memoires

PIC/S Guidelines on GDP of Active Substances for Human Use

PI 047-1

Documents for Inspectors

Guidance documents

PIC/S Guideline on Exposure Limits

PI 046-1

Documents for Inspectors

Guidance documents

PIC/S Guidelines on Excipient GMP Risk Assessment

PI 045-1

Documents for Inspectors

Guidance documents

Annual Report 2017

AR 2017

Documents for the public

Annual reports

Public Summary Version of PIC/S Road Map 2018-2020

PS W 10 2018

Documents for the public

Information documents

Guidance on GMP Inspection Reliance

PI 048-1

Documents for Inspectorates

Inspectorates

Press Release May 2018

PR May 2018

Documents for the public

Press releases

Press Release October 2017

PR October 2017

Documents for the public

Press releases

Annual Report 2016

AR 2016

Documents for the public

Annual reports

Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects

PI 010-5

Documents for Inspectorates

Inspectorates

Press Release March 2017

PR March 2017

Documents for the public

Press releases

Press Release July 2016

PR Jul 2016

Documents for the public

Press releases

Annual Report 2015

AR 2015

Documents for the public

Annual reports

Annual Report 2014

AR 2014

Documents for the public

Annual reports

Procedure on Notification of Foreign Inspections

PI 039-1

Documents for Inspectorates

Inspectorates

Press Release November 2015

PR Nov 2015

Documents for the public

Press releases

Press Release May 2015

PR May 2015

Documents for the public

Press releases

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

Press Release November 2014

PR Nov 2014

Documents for the public

Press releases

Annual Report 2013

AR 2013

Documents for the public

Annual reports

PIC/S Guide to Good Distribution Practice (GDP) for Medicinal Products

PE 011-1

Documents for Inspectors

Guidance documents

Press Release May 2014

PR May 2014

Documents for the public

Press releases

Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments

PE 010-4

Documents for Inspectors

Guidance documents

Press Release November 2013

PR Nov 2013

Documents for the public

Press releases

Annual Report 2012

AR 2012

Documents for the public

Annual reports

Press Release May 2013

PR May 2013

Documents for the public

Press releases

QA on Traceability of Medicinal Gases

PS INF 06 2012 (Rev 1)

Documents for Inspectors

Q&A Documents

Press Release October 2012

PR Oct 2012

Documents for the public

Press releases

Annual Report 2011

AR 2011

Documents for the public

Annual reports

Press Release May 2012

PR May 2012

Documents for the public

Press releases

PIC/S Recommendation on Risk-Based Inspection Planning

PI 037-1

Documents for Inspectors

Guidance documents

Press Release November 2011

PR Nov 2011

Documents for the public

Press releases

Annual Report 2010

AR 2010

Documents for the public

Annual reports

Press Release No 2 June 2011

PR 02 Jun 2011

Documents for the public

Press releases

Press Release No 1 June 2011

PR 01 Jun 2011

Documents for the public

Press releases

QA Distribution Activities for APIs - May 2010

PS INF 20 2011

Documents for Inspectors

Q&A Documents

Validation of Aseptic Processes

PI 007-6

Documents for Inspectors

Guidance documents

Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF)

PE 008-4

Documents for Industry

Site Master Files

Press Release November 2010

PR Nov 2010

Documents for the public

Press releases

Annual Report 2009

AR 2009

Documents for the public

Annual reports

Press Release May 2010

PR May 2010

Documents for the public

Press releases

Press Release November 2009

PR Nov 2009

Documents for the public

Press releases

Standard Operating Procedure Team Inspections

PI 031-1

Documents for Inspectorates

Inspectorates

Annual Report 2008

AR 2008

Documents for the public

Annual reports

Press Release May 2009

PR May 2009

Documents for the public

Press releases

Aide-Memoire on the Inspection of Active Pharmaceutial Ingredients (APIs)

PI 030-1

Documents for Inspectors

Aide-Memoires

Press Release November 2008

PR Nov 2008

Documents for the public

Press releases

Annual Report 2007

AR 2007

Documents for the public

Annual reports

Press Release May 2008

PR May 2008

Documents for the public

Press releases

Press Release November 2007

PR Nov 2007

Documents for the public

Press releases

Isolators Used for Aseptic Processing and Sterility Testing

PI 014-3

Documents for Inspectors

Guidance documents

Recommendation on Sterility Testing

PI 012-3

Documents for Inspectors

Guidance documents

Good Practices for Computerised Systems in Regulated GXP Environments

PI 011-3

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

Guidance on Parametric Release

PI 005-3

Documents for Inspectors

Guidance documents

Aide-Memoire on Medicinal Gases

PI 025-2

Documents for Inspectors

Aide-Memoires

Aide Memoire on Inspection of Quality Control Laboratories

PI 023-2

Documents for Inspectors

Aide-Memoires

Aide Memoire on GMP Particularities for Clinical Trial Products

PI 021-2

Documents for Inspectors

Aide-Memoires

Standard Operating Procedure PIC/S Inspection Report Format

PI 013-3

Documents for Inspectorates

Inspectorates

Site Master File (SMF) for Plasma Warehouses

PI 020-3

Documents for Industry

Site Master Files

Quality System Requirements For Pharmaceutical Inspectorates

PI 002-3

Documents for Inspectorates

Inspectorates

Site Master File (SMF) for Source Plasma Establishments

PI 019-3

Documents for Industry

Site Master Files

Annual Report 2006

AR 2006

Documents for the public

Annual reports

Press Release May 2007

PR May 2007

Documents for the public

Press releases

Recommendation on the Qualification and Training of Inspectors in the Field of Human Blood Tissues and Cells

PI 026-2

Documents for Inspectors

Guidance documents

Press Release December 2006

PR Dec 2006

Documents for the public

Press releases

Annual Report 2005

AR 2005

Documents for the public

Annual reports

Press Release June 2006

PR Jun 2006

Documents for the public

Press releases

Annual Report 2004

AR 2004

Documents for the public

Annual reports

Press Release February 2005

PR Feb 2005

Documents for the public

Press releases

Annual Report 2003

AR 2003

Documents for the public

Annual reports

Press Release June 2004

PR Jun 2004

Documents for the public

Press releases

Press Release November 2003

PR Nov 2003

Documents for the public

Press releases

Annual Report 2002

AR 2002

Documents for the public

Annual reports

Press Release June 2003

PR Jun 2003

Documents for the public

Press releases

Annual Report 2001

AR 2001

Documents for the public

Annual reports

Press Release May 2002

PR May 2002

Documents for the public

Press releases

Annual Report 2000

AR 2000

Documents for the public

Annual reports

Non-Technical Aspects of Inspection (PIC/S Seminar 1999 Booklet)

PS INF 72 2000

Documents for the public

Information documents

Annual Report 1999

AR 1999

Documents for the public

Annual reports

PIC Convention of 1970

PIC Convention

Documents for Inspectorates

Inspectorates