About the Analytical Quality Control Group

Within the quality control environment, there are quite a number of issues that have not yet been addressed adequately. During the ECA Foundation Board Meeting in January 2010, the Board decided to establish a new ECA Working Group on Analytical Quality Control in order to provide a mechanism for action on these topics.

To facilitate and advance discussions and to find answers the Foundation decided to establish a new ECA Interest Group on Analytical Quality Control.

The new group established a 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 topics identified as current interests of the group are, but are not limited to:

• Quality Management Systems and Laboratory Compliance
• Data integrity and security best practices in the laboratory
• Data Quality Management including trend analysis, deviation management and change control
• Sampling and Sample Management
• Qualification and Validation of Laboratory Instruments and Systems
• Life cycle approaches to the validation of analytical procedures
• Specialist Topics including
  • • • Impurity determination
      • Dissolution Testing
      • Stability Testing
      • Reference Standards
      • AQbD
      • Pharmacopoeial standards and procedures

The professionals the group wants to involve in its activities include technical staff and management involved in both routine Quality Control & R&D testing laboratories covering APIs, excipients, drug products, including biopharmaceutical products, and herbal medicinal products.

Board of Directors:

The members of the ECA Analytical Quality Control Group Advisory Board are:

Please find here all Members of the Authority Board of the ECA Foundation.