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 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
|
|
 | | 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.
|
