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Within the quality control environment, there are quite a number of issues that have not yet been addressed adequately. During the ECA Foundation Board Meeting in January 2010, the Board decided to establish a new ECA Working Group on Analytical Quality Control in order to provide a mechanism for action on these topics.

To facilitate and advance discussions and to find answers the Foundation decided to establish a new ECA Interest Group on Analytical Quality Control.

The new group established a set of goals and objectives:

  • Provision of a European wide networking platform for Analytical Chemist and Scientists working in and managing a Quality Control environment.
  • Promotion of active discussion of the latest regulatory requirements for Quality Control within the European Union and US.
  • Identification and addressing of technical issues and challenges within the Quality Control environment including training needs.
  • Active support for a harmonised approach to common problems and issues by the generation of discussion/position papers and generic procedures via expert working groups.
  • Facilitation of effective and efficient communication between industry, competent authorities and the pharmacopoeias.
The topics identified as current interests of the group are, but are not limited to:
  • Quality Management Systems and Laboratory Compliance
  • Data integrity and security best practices in the laboratory
  • Data Quality Management including trend analysis, deviation management and change control
  • Sampling and Sample Management
  • Qualification and Validation of Laboratory Instruments and Systems
  • Life cycle approaches to the validation of analytical procedures
  • Specialist Topics including
    • Impurity determination
    • Dissolution Testing
    • Stability Testing
    • Reference Standards
    • AQbD
    • Reference Standards
    • Pharmacopoeial standards and procedures
The professionals the group wants to involve in its activities include technical staff and management involved in both routine Quality Control & R&D testing laboratories covering APIs, excipients, drug products, including biopharmaceutical products, and herbal medicinal products.

Board of Directors:

The members of the ECA Analytical Quality Control Group Advisory Board are:
Dr Christopher Burgess - Burgess Analytical Consultancy LtdDr Christopher Burgess
Burgess Analytical Consultancy Limited, UK,
Qualified Person, USP Council of Experts 2010 to 2025 and Chairman of the AQCG Board.
Silviya Dimitrova - TEVA Pharmaceuticals IndustriesMs Silviya Dimitrova
TEVA Pharmaceuticals Industries, Bulgaria
QP & Director Global Quality Services Bulgaria and Global QTA.
Dr Joachim Ermer - Ermer Quality ConsultingDr Joachim Ermer
Ermer Quality Consulting, Germany
Patrick Jackson - GSKPatrick Jackson
Investigator in Chemistry, Manufacturing and Controls - Analytical
Dr Gerd Jilge - Boehringer Ingelheim Pharma GmbH & Co. KGDr Gerd Jilge
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Retired Head of a Method Development Laboratory.
Dr Bob McDowall - R D McDowall LimitedDr Bob McDowall
R D McDowall Limited, UK
Member of the ECA IT Compliance Interest Group
Margarita SabaterMs Margarita Sabater
Genmab A/S, Denmark
Senior CMC Specialist, Analytical.

Please find here all Members of the Authority Board of the ECA Foundation.