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NEWS/PUBLICATIONS

• QPA News

  • 3 February 2009: Delegates Give 3rd QP Forum Good Grades

  • 4 September 2008: European Qualified Person (QP) Association passes 1000 Members Mark

  • 3 July 2008: European Qualified Person Association publishes Results of a Survey on Monitoring of Changes

  • 17 June 2008: European QP Association Nominates Martine Tratsaert as new Advisory Board Member

  • 10 April 2008: European QP Association Initiates Shared Audit Database

  • 28 February 2008: Review of the QP Education Course in Vienna, 21–22 February 2008

  • 21 January 2008: European QP Association Plans on Launching an Interest Group for Advanced Therapies

  • 10 January 2008: GMP Webcast from the 2nd QP Forum available for free

  • 14 December 2007: The 2nd Forum of the European Qualified Person Association a Complete Success

  • 8 August 2007: Free Webcast from the Chairman of the European QP Association Available

  • 30 April 2007: EMEA and European Commission Publish Document to describe the Issue and Update of GMP Certificates

  • 15 December 2006: European QP Association Nominates Dr Christopher Burgess as new Advisory Board Member

  • 13 December 2006: European QP Association's first QP Forum a Complete Success

  • 28 November 2006: Dr Bernd Renger named Chairman of the European QP Association

  • 04 October 2006: New European QP Association Counts more than 350 Members already

  • 10 August 2006: European Compliance Academy (ECA) Advisory Board Establishes European Qualified Person Association

• QPA Publications

  • Q and A Document No 1: Qualified Person and API Production

  • Good Practice Guide No 2: Duties and Responsibilities for Qualified Persons in the EU

  • Q and A Document No 2: Frequently Asked Questions

  • Q&A Session at the QP Forum 2008 in Munich, Germany – Part I

  • Q&A Session at the QP Forum 2008 in Munich, Germany – Part II

  • Q&A Session at the QP Forum 2008 in Munich, Germany – Part III

• Authority News

  • 25 February 2009: EMEA Publishes New Version of the Reflection Paper on QP Discretion

  • 13 May 2008: Revised Chapter 4 of the EU Guideline to GMP gives explanations about the QP's responsibilities regarding documentation review and approval

  • 23 April 2008: Draft Annex 13 Released: Section 44 Reworded to Enhance Understanding of the Two-Step Release Procedure

  • 11 April 2008 European Commission: Public consultation on revisions of GMP Annex 11 on Computerized Systems and related changes in GMP Part I/ Chapter 4 on Documentation

  • 10 April 2008 European Commission: Implementation of the Advanced Therapies Regulation: public consultation on the revision of Annex I to Directive 2001/83/EC

  • 19 March 2008 EMEA: Canada and EU agreed to cover Canadian natural health products under the scope of the MRA

  • 17 March 2008 EMEA: Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicines

  • 13 March 2008 EMEA: Reflection Paper on Water for Injection Prepared by Reverse Osmosis

  • 11 March 2008 European Commission: Public consultation in preparation of a legal proposal to combat counterfeit medicines for human use - key ideas for better protection of patients against the risk of counterfeit medicines

  • 4 March 2008 European Commission: Adoption of the Commission proposal on variations (co-decision part)

  • 18 February 2008 EMEA: GMP Annex 1 of the GMP Guide has been revised

  • 18 February 2008 EMEA: Revision of GMP Guidelines to implement concept of Quality Risk Management

  • 12 February 2008 EMEA: An update on the status of revsion of Chapter 5 of the GMP Guide concerning "Dedicated Facilities"

  • 18 December 2007 EMEA: Workplan 2008 for GMP/GDP Inspectors Working Group

  • 17 October 2007 EMEA: Guideline on Stability testing: Stability testing of existing active substances and related finished products

  • 18 September 2007 EMEA: Annex 2 of the GMP Guide

  • 7 August 2007 EMEA: GMP Annex 6 "Manufacture of Medicinal Gases": Draft revision for public consultation

  • 24 July 2007 EMEA: Questions/Answers on implementation of the harmonised microbiological chapters 2.6.12, 2.6.13 and 5.1.4 of the European Pharmacopoeia

  • 28 March 2007 MHRA: UK MHRA Publishes Guidance for Qualified Person

  • 21 July 2006 EMEA: Question and Answer Document on GMP matters

  • 24 March 2006 EMEA: GMP Information for QP Compliance with the requirements of the Marketing Authorisation

  • 24 March 2006 EMEA: PAT Presentation of information in Marketing Authorisation dossiers

  • 23 November 2005 EMEA: Questions and Answers on PAT (update concerning process validation)

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