SCOPE
The official quality control of pharmaceuticals (for human and veterinary use) in order to evaluate their quality, safety and efficiency.
The objective of the control is:
- The protection of public health in relation to quality, safety and efficiency of pharmaceutical products until their expiration date.
- The help the rational development of Trade and Pharmaceutical Industry and to enhance the competitiveness of their products.
- To upgrade the services provided by the Laboratory, through its participation in the European Network of Official Medicines Laboratories (OMCL Network).
- To provide advice and reliable laboratory data to the Drug Council for support and implementation of policy decisions and administration.
ACTIVITIES
The Laboratory for the Quality Control of Pharmaceuticals is one of the oldest Laboratories of the SGL (it was founded in 1932). Is the Official Medicines Control Laboratory in Cyprus and is the competed Laboratory for the implementation of physicochemical quality control on Pharmaceutical products, for human and veterinary use, in the frame of the relevant Cypriot legislation.
Compliance Control, Monitoring and Surveillance Programmes
For the physicochemical quality control of the pharmaceutical products for human use, the Laboratory in collaboration with the competent authority, the Pharmaceutical Services of the Ministry of Health, implements in the frame of a collaboration protocol, a national surveillance program on the basis of the relevant legislation (Law N.70 (I) 2001 up today).
The Laboratory, accordingly, for the quality control of pharmaceutical preparations for veterinary use in collaboration with the competent authority, the Veterinary Services of the Ministry of Agriculture, Natural Resources and Environment implements in the frame of a collaboration protocol a national surveillance program, on the basis of the relevant legislation (Law N.10 (I) 2006 up today).
The analysed samples are submitted:
- by the Pharmaceutical Services of the Ministry of Health in order to check the quality of the drugs available in the Cypriot market or provided by the public hospitals.
- by the Veterinary Services.
- by the competent authorities for investigation of complaints and other problems
- for market surveillance purposes and proficiency studies within the activities of the Official Medicines Control Laboratories Network (OMCL Network of EDQM).
RESEARCH
The quality control and the applied research performed by the Laboratory contribute to the:
- Improvement of the quality, safety and the efficacy of the pharmaceutical preparations through laboratory testing during their distribution.
- The research and development of testing methodology.
- The effective quality control of the local pharmaceuticals industry in order to increase the competitiveness of products and the growth of the export trade.
- The successful implementation of the Cypriot and European legislation and best practice in the field of the pharmaceuticals quality control.
The implementation of applied research had in some cases resulted in changes of official testing methodologies. Research studies of the Laboratory have been published in official European scientific journals or presented on conferences.
INTERNATIONAL PARTNERSHIP
The Laboratory is a member of the Network of the Official Medicines Control Laboratories of the European Directorate for the Quality of Medicines and Health Care (OMCL Network, EDQM) and actively participates in almost all activities of the network such as proficiency tests schemes, the Centrally Authorised Products Testing Program (CAP Programme), the market surveillance program of products of the Mutual Recognition Procedure (MRP / DCP), the Mutual Join Audits Program (MJA) to check compliance with the ISO / IEC/ IEN 17025 by the different OMCLs, as well as various technical experts working groups of the Network. It participated and still participates in the Steering Committees of the Network and for the quality control of the centrally authorised products, GEON Advisor Committee and CAP Advisor Committee respectively.
In addition to its accreditation, according to the ISO /IEC/ EN 17025 standard, the Laboratory during 2007 was inspected from the Canadian Authorities in the frame of the MRA (Mutual Recognition Agreement) between the European Community and the Authorities of Cannada for the testing of pharmaceutical products. The inspection was successful and the Laboratory was declared as equivalent to the Canadian one for the quality control of pharmaceuticals.
The scope of accreditation of the Laboratory according to ISO/IEC 17025:2017 can be found on the web page CYS-CYSAB (Accredited Bodies, Laboratories of the State General Laboratory of Cyprus).