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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.

The Rapid Microbiological Methods (RMM) Group
The RMM Working Group was founded in June 2006 at the German Federal Agency for Sera and Vaccines by 11 representatives from the European Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute (PEI). This group’s goals are to help both authorities and industry get a better understanding of the requirements for the introduction of RMMs and to provide them with guidance based on case studies and available experience (e.g. by publishing Best Practices Papers).
www.rapid-micro-group.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.
The Analytical Quality Control Group

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.
The Validation Group

Good Distribution Practice (GDP) Group
The Foundation’s GDP Group 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.
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 

 
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