ECA Foundation

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
    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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