ECA Interest & Working Groups
Advanced Training services are provided through the ECA Foundation’s ECA Academy which organises and conducts GMP courses, conferences and webinars. To accomplish its goals the ECA Foundation is additionally comprised of various working and interest groups it established in the last years. Inviting industry and authority professionals to get actively involved these groups are driving various activities in specific areas – like organising training themselves, conducting surveys to provide feedback to guideline drafts, writing Good Practice Guides or white papers and much more.
To find out more about the various working and interest groups please see these groups’ sites:
European Qualified Person Association
The European QP Association has been the voice of Qualified Persons and similar functions in the European pharmaceutical industry since its foundation in 2006. It provides QPs in Europe and professionals in similar functions with a platform for sharing and exchanging experience as well as for discussing latest regulatory requirements. This way, the Association supports members in identifying and addressing difficulties and challenges - and in turn supports the Association in its goal to aim for a harmonised European approach. Today, the Association counts more than 2.300 members from across Europe and beyond (from over to 40 countries). Please visit the website of the European Qualified Person Association for more information.
Pharmaceutical Microbiology Group
The Pharmaceutical Microbiology Group was initially founded as RMM Group. As it increasingly became the contact point for all microbiological topics, questions from members as well as from authorities, it extended its scope and activities - and was thus renamed. Today, the group provides advice on all different subjects in pharmaceutical microbiology. Please visit the website of the Pharmaceutical Microbiology Group for more infomation.
Analytical Quality Control Group
The Analytical Quality Control Group is the networking platform for Analytical Chemists and Scientists. Its aim is to facilitate an active discussion of the latest regulatory requirements as well as to identify and address technical issues and challenges. In addition it wants to support a harmonised approach through providing discussion/position papers and generic procedures via expert working groups and to foster an effective and efficient communication between industry, competent authorities and the pharmacopoeias. Please visit the website of the Analytical Quality Control Group for more information.
Process Validation changed significantly in the US and in the EU – from the magic three batches to a more process knowledge and understanding concept based on scientific sound principles. For that reason the ECA Foundation decided to set up the Process Validation Group in June 2011. Through its networking platform it aims to facilitate active discussions of the latest regulatory requirements and to identify and address technical issues and challenges. Discussion/position papers and generic procedures are further supposed to provide an active support for a harmonised approach to common problems and issues. Please visit the website of the Validation Group for more information.
European GDP Association
The European GDP Association was founded in March 2013 - originally as an Interest Group. Today, the Association's objective is to provide all stakeholders involved in Good Distribution Practice (GDP) with information and guidance documents on GDP interpretation and implementation. It also wants to represent Responsible Persons for GDP, Logistic Managers and other individuals involved in a secure pharma supply chain - and to facilitate the exchange between these groups through a discussion forum and a GDP Supplier Database. Please visit the website of the European GDP Association for more information.
Visual Inspection Group
In December 2013 representatives of the pharmaceutical industry and from GMP authorities together established the ECA Visual Inspection Group. Taking advantage of these experts comprehensive experience and knowledge and applying the learnings from previous conferences this Group's goal is to contribute to a harmonisation. With their best-practice-paper the Group wanted to develop a document as a reference for controversial issues much rather than a strict requirement document. Please visit the website of the Visual Inspection Group for more information.
Data Integrity & IT Compliance Group
Data Integrity has become an intensively discussed topic in the past years - and one of the most important topics during inspections. Therefore the ECA IT Compliance Group founded in December 2014 by representatives of the pharmaceutical industry and inspectors extened its scope to cover Data Integrity issues as well. Today, the Data Integrity & IT Compliance Group's objective is to support pharmaceutical industry in implementing new IT technologies with regard to international GMP requirements. Please visit the website of the Data Integrity & IT Compliance Group for more information.
The ATMP Interest Group's addresses persons involved in the development, manufacturing, quality management and marketing authorisation of Advanced Therapy Medicinal Products (ATMP). Established in 2017, it facilitates the exchange between sciences, industry, competent authorities and the pharmacopoeias. THe Group also promotes an active discussion on the latest regulatory requirements for ATMP within the European Union, US and world wide. Moreover, it supports members in identifying and addressing regulatory, scientific and technical issues and challenges - including training needs. Please visit the website of the ATMP Interest Group for more information.
Medical cannabis has been permitted for prescription in Germany since 2017, causing a need for producers supplying pharmacists and physicians with the newly legalized drug. In addition, more and more countries around the world are following Germany by introducing programs in order to legalize cannabis for medical use. However, searching for answers to GMP and other regulatory questions with regard to medical cannabis is difficult and time-consuming. The ECA’s Cannabis Working Group therefore addresses specific GMP aspects to consider for Growers, Manufacturers, Start-Ups, Suppliers, Importers, QPs and QA/QC personnel involved in Cannabis production and release as well as GACP/GMP/GDP Inspectors responsible for issuing a GMP certificate or manufacturers/import license. The Group collects and summarizes GMP and other regulatory information and documents currently available on a global level and provides useful comments and an Annex with further information.
Annex 1 Task Force
In December 2017, the European Commission published the long-awaited revision draft of Annex 1 "Manufacture of Sterile Medicinal Products" of the EU Guideline for Good Manufacturing Practice for drug products and drug substances. The guideline published in 1971 had last been revised in parts in 2008. To comment the proposed revision to Annex 1 to the EU GMP Guide on the Manufacture of Sterile Medicinal Products the ECA Foundation specifically set up set up an Annex 1 Task Force. Members of this Task Force are: Dr Friedrich Haefele, formerly Boehringer Ingelheim (Germany); Alexandra Staerk, Novartis Basle (Switzerland); Dr Tilmann Rock, Roche Mannheim (Germany); Dr Ingrid Walther, Independent Expert (Germany); Arjan Langen, MSD (The Netherlands); Stephan Loew, CSL Marburg (Germany); Walid El Azab, Steris (Belgium); Dr Jean-Denis Mallet, NNE Pharmaplan (France); Dr Bernd Renger, Independent Expert (Germany).