Reference standards play a key role in the development and manufacture of medicinal products. This year, the domestic industry faced the risk of a shortage of reference standards, most of which had been previously supplied by foreign companies. Ensuring the manufacture of our own reference standards has become one of the main tasks in meeting the needs of the domestic pharmaceutical industry.
The nomenclature of the reference standards manufactured by FSUE "Endopharm" in 2022 has increased by more than 2 times compared to the previous year and consisted of 93 items, 28 of which had the status of international reference standards. The plans for 2023 include the addition of at least 50 new items to the existing portfolio of reference standards, including the Impurity Reference Standards.
It is important to note that more than half of the reference standards manufactured by FSUE "Endopharm" are intended for quality control of medicinal products included in the List of Vital and Essential Medicines.
Alongside the expansion of the product range, continuous work is being carried out to increase the shelf life of the manufactured reference standards, thanks to which it has been increased by 2 times in some positions.
The competence of the Enterprise in terms of development and manufacture of reference standards is developed by highly qualified specialists with about 15 years of experience, including narcotics and psychoactive substances.
The state standard reference ssamples produced by the FSUE "Endopharm" comply with the requirements of certified reference standards designated according to the international CRM classification, which are used at all stages of the measurement process, including the development, methods validation, calibration, quality control, monitoring of trends in the investigation of OOS results in the routine analysis, which enables to include these reference standards in the regulatory documentation both at the stage of registration and renewal of registration of medicinal products.
Reference standards have a wide range of applications. Apart from the quality control of pharmaceutical products, reference standards by FSUE "Endopharm" are in demand for the calibration of measuring instruments, for the quality control of products in veterinary medicine, cosmetics, food industry, expert activities.
The manufacture of domestic reference standards enables to reduce dependence on imports, as well as to reduce the period of testing.
Comment type is not specified in the component properties.