OMCL - Official Medicines Control Laboratories

The Official Medicines Control Laboratories support the regulatory authorities and the national Inspection Services in controlling the quality of medicinal products on the market by independent re-testing based on legal requirements.

In the mid-1990s a European OMCL Network was formed under the aegis of the Council of Europe in Strasbourg, France. This Network is coordinated by the European Directorate for the Quality of Medicines (EDQM) of the Council of Europe. This Network not only integrates the countries of the European Union (EU), the European Economic Area (EEA) and Switzerland, but also most of the Central and Eastern European Countries. Approximately 80 OMCLs are now involved, including the Canadian Health Products and Food Branch Inspectorate (Inspectorate) laboratories.

The aims of the Network are :

• to facilitate the exchange of knowledge and expertise
• to coordinate the administrative and technical activities of common interest
• to harmonize the testing activities by use of common standards, based on legal requirements
• to organize post-marketing surveillance studies of centrally authorized products (with a European marketing authorization)
• to allow mutual recognition of Control Authority batch release for blood products and vaccines in the EU and the EEA
• to ensure quality and comparability of the results within the Network by implementing a quality system based on EN 45001 (ISO/TEC 17025) in the OMCLs and organizing Proficiency Testing Studies on basic methods of analysis
• to promote development and validation of new test methods and definition of new quality requirements.

Since 1999, the Network started to implement a system of Mutual Joint Visits and Mutual Joint Audits (MJV/A) to help each other in implementing and in maintaining a quality system based on EN 45001 (ISO/TEC 17025) with respect to the regulatory requirements and the nature of the OMCL activities. These MJV/As can be seen as peer reviews. They are coordinated by EDQM and are carried out according to a standardized procedure by auditors recruited from the Network and who are trained in the system and are familiar with the regulatory character of the OMCL-type activities. The MJV/As are carried out upon request by an OMCL on a voluntary basis.