The ECA Analytical Quality Control Group
The group aims at providing a networking platform for analytical chemists in development and manufacturing, quality control, regulatory affairs and quality assurance professionals in order to facilitate an active discussion of the impact of the latest regulatory changes as well as identifying and addressing technical issues and challenges.
In addition, it actively supports a harmonised approach by;
- Providing guidance documents on topics of specific interest to Quality Control
- Developing discussion/position papers and generic procedures via expert working groups
- Facilitating an effective and efficient communication between industry, competent authorities and the pharmacopoeias regarding analytical quality control.
Achievements
The Analytical QC Group has already developed the following guides which are available to members free of charge:
Guide for Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Guidance: SOP on Out-of-Specification (OOS) Results
Guidance: Out of Expectation (OOE) and Out of Trend (OOT) Results
Current Projects
Guidance: Analytical Procedure Lifecycle Management