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:
The topics identified as current interests of the group are, but are not limited to:
- 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 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.
- 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
- Reference Standards
- Pharmacopoeial standards and procedures
Board of Directors:
|The members of the ECA Analytical Quality Control Group Advisory Board are:
||Dr Christopher Burgess
Burgess Analytical Consultancy Limited, UK,
Qualified Person, USP Council of Experts 2010 to 2025 and Chairman of the AQCG Board.
||Ms Silviya Dimitrova
TEVA Pharmaceuticals Industries, Bulgaria
QP & Director Global Quality Services Bulgaria and Global QTA.
||Dr Joachim Ermer
Ermer Quality Consulting, Germany
Investigator in Chemistry, Manufacturing and Controls - Analytical
||Dr Gerd Jilge
Boehringer Ingelheim Pharma GmbH & Co. KG, Germany
Retired Head of a Method Development Laboratory.
||Dr Bob McDowall
R D McDowall Limited, UK
Member of the ECA IT Compliance Interest Group
|Ms Margarita Sabater
Genmab A/S, Denmark
Senior CMC Specialist, Analytical.
Please find here all
Members of the Authority Board of the ECA Foundation.