Official Medicines Control Laboratories, OMCL NETWORK
General European OMCL Network, GEON (hereinafter referred to as – the Network)
It was formed in mid-nineties under the patronage of the European Council, aiming at the establishment of mutual trust through adjusted working procedures as well as the enhancement of the exchange of data gained during various activities (market surveillance testing, pre-authorization testing, official batch release testing etc.)
The role of the Network is to coordinate technical activities of control laboratories in Europe and to affect further development through adjusted standards based on legal requirements for the control of medicinal products, such as standards of the European Pharmacopoeia and generally adopted QA standards.
1. General activities
- QA activities - general approach to the development and implementation of QA system (EN 45001/ISO 17025) in all OMCL.
- Mutual Joint Visit (Tutorial Program) / Audit (MJV/MJA) Program
- Market Surveillance Studies (MSS) - collaborative MSS are carried out on the already marketed products in order to assure and determine whether the same type of product has appropriate qualities throughout different Member States.
- Proficiency Testing Scheme (PTS) - PTS is carried out in order to ensure comparability of the results reached in different laboratories within the Network, which helps establishing mutual trust among OMCL laboratories.
- Various education programs
- Development of current regulations and analytic researches.
2. Specific EC (European Communities) activities based on the process of mutual recognition of testing:
- CAP tests (Centralized Authorized Procedure)
- 'Batch release' of biological preparations (Official Control Authority Batch Release, OCABR)
The Network holds annual meetings in one of the Member States, presenting its activities and program.