Laboratory testing of medicines forms part of the state supervision exercised by the State Agency of Medicines. The aim is to make sure that the medicines used in Estonia meet the applicable quality requirements and thereby contribute to ensuring the efficacy and safety. Although pharmaceutical companies check the quality of each batch before release, random tests of marketed medicines are carried out in the Laboratory of the State Agency of Medicines. The quality of medicines prepared in pharmacies is verified as well. Laboratory tests are also important for the detection of counterfeit medicines.
The Laboratory has an ongoing market surveillance plan under which more than 400 medicines are analysed each year, including authorised and unauthorised medicines, medicines prepared in pharmacies, active ingredients and excipients used in the manufacture of medicines. The medicines to be analysed are selected in cooperation with other departments of the Agency, taking into account the extent of the risk arising from possible quality problems (wide use, relatively instable active ingredients, similar preparations from different manufacturers etc.). Samples are usually taken at wholesale or pharmacy levels, and occasionally also from the marketing authorisation holders. It is important to sample towards the end of the supply chain, as this also enables to discover possible deviations caused by storage and transport.
Wide range of chemical and pharmaceutical methods are used by the Laboratory of the Agency, enabling the testing of different pharmaceutical forms and as wide a spectrum of active ingredients as possible. We also test endotoxins in injections using the biological method.
By our work counterfeiting has been confirmed in illegally sold products, active pharmaceutical ingredients have been detected in herbal and other preparations that are advertised as “extremely efficacious, however safe and natural” dietary supplements.
The Laboratory acts in accordance with the international standard ISO/IEC 17025 and the guidelines of the Official Medicines Control Laboratories (OMCL) operating under the aegis of the European Directorate for the Quality of Medicines & HealthCare (EDQM).
Cooperation between European medicines control laboratories ensures the complementary nature of laboratories’ analytical capabilities. The cooperation network was established in 1995. The laboratory of the State Agency of Medicines has been a member of the network since 1998. This provides an opportunity to verify all medicines placed on the market in Estonia, even if some of the necessary methods have not been introduced in our laboratory. Within the scope of cooperation, the workload is shared between participating laboratories, and samples and test results are exchanged in respect of medicines authorised for marketing by way of mutual recognition. The analysis of centrally authorised medicines is coordinated by the European Medicines Agency and the EDQM, with the market surveillance and laboratory testing of these medicines being shared between EU Member States. The laboratory of the State Agency of Medicines regularly participates in the control of centrally authorised medicines, analysing 1–2 preparations per year.
Occasionally, pan-European market surveys are also organised in which preparations containing the same active ingredient are analysed in various countries. These surveys give a good overview of the quality of medicines made by different manufacturers which contain the same active ingredient.
So that the results of different laboratories can be accepted, it is important for the laboratories to implement similar quality systems. To this end, a system of collegiate control (Mutual Joint Audit/Mutual Joint Visit, MJA/MJV) has been developed and is being implemented through which the network’s members evaluate one another’s compliance with the ISO 17025 standard. The conformity of the activities carried out by the laboratory of the State Agency of Medicines to the international standard was confirmed in an initial assessment conducted in 2007 and reassessment conducted in 2011. The full membership of the State Agency of Medicines in the OMCL network ensures international recognition of the test results.
The EDQM organises international proficiency testing studies (PTS) in the field of medicines quality control which enable analytical competence to be compared with that of other participating laboratories. The laboratory of the State Agency of Medicines has been participating in these studies since 1998 and has achieved excellent results so far.
The Laboratory is accredited by the Estonian Accreditation Centre for analyses of medicines (registration number L 217).