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.
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