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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).
www.qp-association.eu
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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
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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
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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
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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
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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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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.
ATMP Interest Group
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