About the ECA
The ECA Academy – part of the ECA Foundation
The ECA Academy is the educational organisation of the ECA Foundation (please see www.eca-foundation.org) for more detailed information). It develops and organises a wealth of international education courses, conferences (also as part of a GMP Certification Programme) and webinars around GMP and regulatory compliance, picking up emerging GMP challenges and currently discussed subjects. While courses and webinars are designed to provide continuous education for GMP professionals in production, quality control, quality assurance etc, European conferences are organised as discussion forums on new trends and developments.
The Academy is supported by the ECA Foundation Advisory Board. This Board acts as conceptual sponsor in the development of new courses and conferences and ensures best quality and participant satisfaction by evaluating all events.
The ECA Analytical Quality Control Group
Within the quality control environment there are quite a number of issues that have not been addressed adequately yet. These issues were discussed during the ECA Foundation Board Meeting in January 2010 – and the Board therefore decided to establish a full ECA Working Group on Analytical Quality Control.
The original ECA Analytical Quality Control Interest Group, founded in 2011, had previously developed a harmonized SOP on the Handling of Out-of-Specification Results as its first project. Version 2 of this SOP was finalized in 2013 and this OOS SOP is available free to all ECA Members in the ECA Members Area.
After the creation of this SOP, the next objective was the elaboration of an OOE-/ OOT-Laboratory Data Management Guidance document covering the following topics:
- methods for statistical process control with regard to the statistical evaluation of the variability of production processes,
- the analysis of trends in stability studies,
- and the handling of Out-of-Expectation (OOE) Results.
The ECA Analytical Quality Control Interest Group’s goal was to have a basic global framework for OOT/OOE within R&D, production and QC laboratories which is acceptable to the authorities and adaptable by individual companies.
This 70 pages Guidance document was completed in November 2016. It is available free to all ECA Members in the ECA Members Area, as well.
The first task of the newly formed AQCG board is the creation of a new guideline on Analytical Procedure Lifecycle Management in conjunction with members of the USP Validation and Verification Expert Panel and is due for completion in Q4 2017.