In July 2021, at the 59th meeting of the Interstate Council for Standardization, Metrology and Certification, additional 17 national reference samples of the Russian Federation, the developer and manufacturer of which is Endopharm, were recognized as interstate reference samples (IRS) and registered in the Register of Interstate Reference Samples for the composition and properties of substances and materials. To date, all the types of Endopharm reference samples are recognized as IRS and can be used along with national reference samples.
The meeting was attended by delegations of national bodies for standardization, metrology, conformity assessment and accreditation of the Republic of Azerbaijan, the Republic of Armenia, the Republic of Belarus, the Republic of Kazakhstan, the Kyrgyz Republic, the Republic of Moldova, the Russian Federation, the Republic of Tajikistan, the Republic of Uzbekistan, as well as representatives of the CIS Executive Committee and the Bureau of Standards.
The interstate status allows the use of IRS “Endopharm” on the territory of a number of foreign countries participating in the “Agreement on a coordinated policy in the field of standardization, metrology and certification”, which contributes to an increase in the national export of the Russian Federation, strengthening scientific, technical and trade and economic ties.
The range of reference samples produced by Endopharm includes 28 items, 17 of which are used in the manufacture of medicines included in the list of vital and essential medicines.
At present, the states-participants of the Agreement have the opportunity to use the IRS “Endopharm”, the price of which is more affordable than the one of the RSs of foreign pharmacopoeias, on the territory of their countries. The expiration date of each batch of a reference sample manufactured by Endopharm is indicated in the data sheet and on the label, which eliminates the risk of withdrawing one batch and replacing it with another. This advantage allows planning the purchase of the required number of reference samples and reducing the costs associated with the exchange rate and delivery times from abroad.
It should be noted that in the autumn of 2020, Endopharm received accreditation for compliance with the requirements of the international standard ISO 17034:2016, confirming the scientific and technical competence of the Enterprise to produce reference samples that meet international quality standards, taking into account modern requirements for the organization of the production process.
Information on the nomenclature of reference samples produced by Endopharm is available in the Federal Information Fund for Ensuring the Uniformity of Measurements (FSIS Arshin) https://fgis.gost.ru/fundmetrology/registry/19, as well as on the website of the Enterprise https://endopharm.ru/product/standartnye-obraztsy/
Comment type is not specified in the component properties.