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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 Quality Control.
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 are:
- Quality Management Systems and Laboratory Compliance
- Sampling and Sample Management
- Qualification and Validation of Laboratory Instruments and Systems
- Data Quality Management
- Specialist Topics
– Impurities
– Dissolution Testing
– Stability Testing
– Reference Standards
– Others
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 need to
join the ECA as member first.
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