The ECA Foundation Groups
Interest & Working Groups
The ECA Academy is the ECA Foundation’s educational organisation. In addition to the Academy organising and conducting GMP courses and conferences, the Foundation also comprises a number of interest and working groups.
The European QP Association
The European QP Association was founded in July 2006 with the goal to provide QPs in Europe with a platform allowing them to exchange experience, discuss the latest regulatory requirements, to identify and address difficulties and challenges and to support a harmonised European approach. Today, the Association counts more than 2.300 members from across Europe and beyond (from over to 40 countries).
European GDP Association
The Foundation’s GDP Association was established in March 2012. Its goals are to develop a set of guidance documents to assist the implementation of the new EU GDP Guidelines (2013/C68/01) by those involved in Medicines storage and distribution and to make the documents available free of charge to PQG and ECA members.
Pharmaceutical Microbiology Working Group
Founded as RMM Group the group increasingly became the contact point for all microbiological topics, questions from members as well as from authorities. Therefore, the Group was renamed to Pharmaceutical Microbiology Working Group and extended its scope and activities – now providing advice on to all different subjects in pharmaceutical microbiology.
The Analytical Quality Control Group
The group aims at providing a networking platform for Analytical Chemist and Scientists and to facilitate an active discussion of the latest regulatory requirements as well as identifying and addressing 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.
The Validation Group
With the looming paradigm shift in Process Validation 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 – the ECA Foundation also decided to set up the Process Validation Group in June 2011. This group also wants to establish a European wide networking platform for facilitating 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.
Visual Inspection Group
The ECA Visual Inspection Group was founded in December 2013 by representatives of the pharmaceutical industry and GMP authorities. This group's goal is to take advantage of the long lasting experience and knowledge of its members and the learnings from previous conferences to contribute to a harmonisation and to generate a best-practice-paper. Much rather than a strict requirement document, this paper is intended to be a reference for controversial issues.
Data Integrity & IT Compliance Group
The ECA Data Integrity & IT Compliance Group was founded in December 2014 by representatives of the pharmaceutical industry and inspectors. The objective of the group is to support pharmaceutical industry to implement new IT technologies with regard to international GMP requirements.
It is the Interest Group’s objective to provide a Europe-wide networking platform for persons involved in the development, manufacturing, quality management and marketing authorisation of Advanced Therapy Medicinal Products (ATMP) by facilitating effective and efficient communication between sciences, industry, competent authorities and the pharmacopoeias. The Group also wants to promote an active discussion on the latest regulatory requirements for ATMP within the European Union, US and world wide. And it finally intends to identify and address regulatory, scientific and technical issues and challenges, including Training needs.