The tasks of Swissmedic's Official Medicines Control Laboratory (OMCL) are on the one hand laboratory analysis, method developments and method examinations of pharmaceutical medicinal products or active substances, and expert advice, and on the other it serves as the authority for the batch release of stable blood products and vaccines. The pharmaceutical and biological aspects of the laboratory are equivalent as far as the OMCL's analysis capacity is concerned.
Official Medicines Control Laboratory
Test method for nitrosamines in sartans
Safety limit test method for NDEA/NDMA in sartans based on GC-MS (31_PV_169) (PDF, 202 kB, 23.07.2019)(the document is currently only available in German)
Safety limit test method for NDEA/NDMA in sartans (31_PV_163) (PDF, 87 kB, 07.12.2018)(the document is currently only available in German)
Division Laboratories (OMCL)
The accredited Swissmedic laboratory is responsible for the official batch release of stable blood products and vaccines, and supports the various sectors of Swissmedic by means of laboratory analysis and method developments and assessments.
The laboratory carries out pre-authorisation analysis, method examinations and tests parallel imports for the Authorisation Sector. For the Market Surveillance Sector, the OMCL collaborates with thee periodic monitoring of product quality and provides support in the case of defective products and illegal medicinal products (e.g. counterfeit medicines), in the form of analytical findings. For the Legal Affairs Sector, it provides analytical support for penal proceedings, and for the Licensing Sector the further development of the pharmacopoeias (Ph. Helv. and Ph. Eur.) constitutes an important role.
The OMCL is part of the European network of official control laboratories. The network is operated by the European Directorate for the Quality of Medicines and Health Care (EDQM) in Strasburg, and its objective is the mutual exchange of information and the elaboration of common guidelines. Thanks to a bilateral agreement with the EU, the OMCL is a full member of the European Official Control Authority Batch Release (OCABR). The bilateral agreement provides for mutual recognition regarding official batch releases of products that are manufactured in Switzerland or in the EU and for which official batch release is required.
In addition to the internal clients, the OMCL also works for the Swiss Confederation (Federal Office of Public Health, FOPH), various Cantons and international organisations (the WHO and EDQM), and foreign OMCLs for various special analyses.
In order to ensure keep abreast with the latest status of scientific and technical knowledge, the OMCL constantly improves its laboratory methods, in collaboration with domestic and foreign partners.
The laboratory trains laboratory assistants in specific areas of biology and chemistry.
The OMCL has gained ISO/IEC 17025 (STS 0158) accreditation as an expert examination entity, and participates regularly at national and international round robin tests within the framework of quality assurance.
Last modification 29.11.2019