The nomenclature of reference samples produced by FSUE Endopharm has more than doubled in 2022 compared to 2021, having reached 93 items, 28 of which with the interstate reference samples status. The plans for 2023 are to add at least 50 new items to the existing portfolio of reference samples, including reference samples of impurities. This was reported in the press service of the Moscow Endocrine Plant.
“Reference samples play a key role in the development and production of medicines. This year, the domestic industry is facing a serious risk of a shortage of reference samples, most of which were previously supplied by foreign companies. Domestic production of reference samples has become one of the main tasks in meeting the needs of the domestic pharmaceutical industry. It is important to note that more than half of the reference samples produced by FSUE Endopharm are intended for quality control of VED-listed drugs,” the message says.
In parallel with the expansion of the product range, continuous work is being carried out to increase the shelf life of the reference samples produced, doubling it for some positions. The competence of the enterprise in the development and production of reference samples is developed by highly qualified specialists with about 15 years of experience, including with narcotic drugs and psychotropic substances, the FSUE said.
“The state reference samples produced by FSUE Endopharm comply with the requirements for certified reference samples designated according to the international CRM classification, which are used at all stages of the measurement process, including the development, validation of methods, calibration, quality control, monitoring trends in the investigation of OOS results in routine analysis, which makes it possible to include these reference samples in regulatory documentation both at the stage of registration and re-registration of drugs,” the press service of the Moscow Endocrine Plant emphasized.
Reference samples have a wide range of applications. In addition to quality control of pharmaceutical products, reference samples provided by FSUE Endopharm are used for verification and calibration of measuring instruments, as well as in product quality control in veterinary medicine, cosmetics industry, food industry, and expert examination. The production of domestic reference samples allows for reducing dependence on imports, as well as accelerating research, the company added.
Endopharm had earlier received permission for the reconstruction and technical re-equipment of the laboratory complex.
