One of the key events for FSUE "Moscow Endocrine Plant", which took place in the autumn of 2020, was accreditation for compliance with the requirements of the international standard ISO 17034:2016, confirming the scientific and technical competence of the Enterprise, which allows the manufacture of reference samples (hereinafter referred to as RSs) that meet international quality standards taking into account modern requirements for the organization of the manufacturing process.
Accreditation certificate: No. ААС.RM.00517 issued by the Accreditation Authority "Association of Analytical Centres "Analitika" and is valid until October 08, 2025.
The specified Accreditation Authority is a full member of ILAC – International Laboratory Accreditation Cooperation, APLAC – Asia Pacific Laboratory Accreditation Cooperation, and APAC – Asia Pacific Accreditation Cooperation. Since May 2009, the Accreditation Authority of the AAC "Analytica" has received the status of a full member of these organizations — a party to the Multilateral Mutual Recognition Agreement. All signatories to the agreement, on the basis of mutual trust, recognize the results of the accreditation work of other signatories within their area of recognition.
Thus, the accreditation obtained allows FSUE "Moscow Endocrine Plant", in accordance with the established policy, to use the Combined ILAC MRA mark on the certificates of manufactured reference samples in accordance with the scope of accreditation, which makes the documents significant abroad, since it directly indicates that it has been issued by the manufacturer, whose accreditation is internationally recognized.
Currently, most of the quality control methods for medicines involve the use of foreign-made reference samples such as: EP CRS, USP RS, BP CRS. The listed reference samples do not contain information on uncertainty and traceability to unit standards, which does not allow their use in the field of state regulation in accordance with the requirements of the Federal Law dated June 26, 2008 No. 102-FZ "On ensuring the uniformity of measurements". In addition, the high cost of the listed reference samples, long delivery terms negatively affect the registration and quality control procedures for medicines.
The use of reference samples of the world's leading pharmacopoeias in practice has a number of peculiarities that complicate their use:
- the American and European pharmacopoeias emphasize that the quality of reference materials is guaranteed only if they are used in accordance with the requirements of the relevant monographs. In every case where a laboratory uses non-pharmacopoeial methods, the use of pharmacopoeial reference samples is possible, but without guaranteeing the relevance of the test results.
- with regard to the shelf life of the RS of the Pharmacopoeia, a method is used in which the shelf life of a reference sample batch is determined by the publication on the official websites of a list of reference samples with a valid shelf life. Thus, a reference sample batch can be withdrawn from sale at any time and replaced with another one. This method of determining the expiration date means that the purchase of reference samples according to the pharmacopoeia shall be planned very carefully, assessing the risks of purchasing too large quantities and too long delivery terms from abroad. It shall also be remembered that after the first opening of the package, the user is responsible for maintaining the properties of the material.
FSUE “Moscow Endocrine Plant” developed and validated methods for quantitative determination of substances by titrimetry and high-performance liquid chromatography. The methods have passed the metrological examination and have been certified by the State Metrological Institute of Rosstandart, thus, it has been confirmed that the methods used in determining the certified characteristics ensure the obtaining of measurement results with the established metrological traceability, with the accuracy necessary to establish the certified value of the reference sample.
State reference samples produced by Federal State Unitary Enterprise "Moscow Endocrine Plant" meet the requirements of certified reference materials designated by the international CRM classification, which are used at all stages of the measurement process, including method validation, calibration, and quality control according to the parameters "Quantitative determination" and "Authenticity".
Each copy of the state reference sample produced by the Federal State Unitary Enterprise "Moscow Endocrine Plant" is accompanied by a data sheet, which obligatorily indicates the certified value, uncertainty, shelf life of a unit of the reference sample, additional information contains identification methods, information on weight loss on drying or water content.
According to production plans, by 2022 the nomenclature to be produced will include at least 150 state and pharmacopoeial reference samples, including reference samples of narcotic drugs, psychotropic substances and their precursors.
The journal "Development and Registration of Medicines" 2016 No. 1 (14) in the article "Reference samples of controlled potent components of analgesic drugs" describes the problem of the lack of state reference samples of controlled narcotic and psychotropic substances, which leads to the impossibility of obtaining legally significant results of quantitative studies of substances of this type and the objects containing them. Manufacture of reference samples of narcotic drugs, psychotropic substances, as well as their precursors listed in the Resolution of the Government of the Russian Federation dated June 30, 1998 No. 681 is a Specific task of the Enterprise.
FSUE "Moscow Endocrine Plant" fully complies with the established requirements for the implementation of legal norms for the organization of their manufacture, the availability of special permissions, licenses for the right to work, admission of personnel, fortification of premises, registration of equipment, conditions of transportation and transfer of controlled substances, provided by the security of specialized organizations.
FSUE "Moscow Endocrine Plant" produces the following groups of reference samples:
reference samples for qualitative analyses (for identification)
- reference samples for quantitative analyses
- reference samples for the analysis of synthetic chemical compounds
- reference samples for the analysis of substances of plant origin
- reference samples for the analysis of substances of biological origin
- reference samples for physical and chemical analyses
- reference samples for instrument calibration and confirmation of the effectiveness of analytical systems
- reference samples of organic and inorganic impurities in pharmaceutical substances
Comment type is not specified in the component properties.