All ECA Activities
The ECA Foundation is Europe´s leading leading Association in the field of pharmaceutical Quality Regulation, especially in the field of GMP and GDP compliance. The not for profit organisation is comprised of an educational organisation (ECA Academy) and various non-profit Associations, Interest and Working Groups - providing comprehensive information and training services. The ECA Academy offers basic and advanced training courses and conferences as well as various well-recognised certification programmes. The Associations, Interest and Working Groups - such as the European QP Association - develop guideline documents and white papers, supporting the information exchange between industry and regulatory authorities. In addition, Task Forces bringing together experts across industry are created on demand, e. g. to comment on new draft Guidelines.
The GMP Auditor Association
Despite a central function within the pharmaceutical quality assurance system the interests of GMP Auditors have so far not been represented adequately. The ECA Foundation closes a gap here. The GMP Auditor Association as the new interest group is also intended to promote the dialogue between the GMP Auditors of the various companies. Establishing such as an interest group for GMP (Good Manufacturing Practice) auditors in the pharmaceutical industry can bring several benefits to both auditors themselves and the overall quality assurance system – like professional development and networking, information exchange as well as advocacy and representation.
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.
The 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 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.
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.