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).
www.qp-association.eu.

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.
www.pharmaceutical-microbiology.org.

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.
www.analytical-quality-control-group.org

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.
www.validation-group.org

The European GDP Association

Established as an Interest Group of the ECA Foundation  in March 2013 the objective of the GDP Group  is to support all stakeholders involved in Good Distribution Practice (GDP) by providing them information about the implementation of GDP. In August 2016, the European GDP Group was reorganised to become the European GDP Association. It is the goal of the Association to represent Responsible Persons for GDP, Logistic Managers and other individuals involved in a secure pharma supply chain. The Association provides its members  guidance documents on GDP interpretation, a discussion forum and a GDP Supplier Database.
www.good-distribution-practice-group.org

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.
www.visual-inspection.org

Data Integrity & IT Compliance Group

The ECA DI & 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.
https://di-itc.gmp-compliance.org/

ATMP Interest Group

The ATMP Interest Group was established in 2017. Its objective is 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. It further wants to promote active discussion on the latest regulatory requirements for ATMP within the European Union, US and world wide as well as to identify and address regulatory, scientific and technical issues and challenges, including training needs.
www.atmp-group.org

The European GMP-Auditor Association

The GMP-auditor has a central function within the pharmaceutical quality assurance system. Until today, there was no representation of interests for this important function holder. The ECA Foundation closes a gap here. The new interest group - established in 2024 - is also intended to promote dialogue between the GMP-auditors of the various companies.
gmp-auditor.gmp-compliance.org