The ECA Analytical Quality Control Group (AQCG) was established in 2010 as part of the ECA Foundation - with the following objectives:
1. Provision of a European wide networking platform for Analytical Chemist and Scientists working in and managing a Quality Control environment.
2. Promotion of active discussion of the latest regulatory requirements for Quality Control within the European Union and US.
3. Identification and addressing of technical issues and challenges within the Quality Control environment including training needs.
4. 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.
5. Facilitation of effective and efficient communication between industry, competent authorities and the pharmacopoeias.
Much effort has already been made in meeting objective 4 in particular by 2017 which has resulted in the generation of three guideline documents proposing harmonised approaches. These documents are available to all ECA members:
- OOS Guideline, v2.1, August 2013
- OOE & OOT Guideline; v1.1 November 2016
- Data Governance and Data Integrity Guideline; v2.0 January 2017
By early 2017, it had become apparent that there was a need to produce a detailed practical guideline attempting to consolidate and harmonise the life cycle approaches for analytical procedures. ECA's Analytical QC Group has thus developed a new and important Analytical Procedure Lifecycle Management Guideline.
This comprehensive new 80 page guideline will be launched at the PharmaLab Congress 2018 in Dusseldorf.
Dr Christopher Burgess
Chairman of the ECA Analytical Quality Control Group