Within the quality control environment there is quite a number of issues
that have not been addressed adequately yet. These issues were partly
discussed during the ECA Foundation Board Meeting in January 2010 – and the
Board therefore decided to establish a new ECA Working Group on Analytical
The new group defined a whole 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 interest of the group and the topics it intends to concentrate on
- Quality Management Systems and Laboratory Compliance
- Sampling and Sample Management
- Qualification and Validation of Laboratory Instruments and Systems
- Data Quality Management
- Specialist Topics
– Dissolution Testing
– Stability Testing
– Reference Standards
The professionals the group wants to address comprises technical staff
and management involved in routine Quality Control & R&D testing
laboratories for APIs, Excipients, drug products as well as for herbals.
If you are interested in joining the group please use the
contact form. Please note, though, that you
join the ECA as member first.
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