ECA Working Groups - Analytical Quality Control

About us

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.

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