The deputies proposed to clarify the concept of “Pharmacopeia standard sample”

In the state Duma a bill on the national system of standardization of medicines. Among other things, the bill provides for the establishment and maintenance of a register of Pharmacopeia reference materials, writes “the parliamentary newspaper”.

The bill also clarifies the concept of “standard pharmacopoeial sample.” It is now established that the sample produced in accordance with pharmacopoeial article. The document contained a list of indicators of quality and methods of quality control of the drug.

The initiative proposes to prescribe that the Pharmacopeia standard sample is including a sample of matter dened according to test results the values characterizing its composition or properties for confirmation of conformity of medicines to requirements.

The project also provides that upon the filing and consideration of the application for the state registration of medicines to provide information about Pharmacopeia standard samples from other countries if they do not exist in the state Pharmacopoeia.

“The proposed bill changes aimed at the development of metrological assurance in the pharmaceutical industry in the development, testing and implementation of pharmacopoeial standard samples of a domestic production, including on the basis of the original substances,” say the authors.

Also, the project indicated that the development of the Pharmacopoeia articles, the owner of a registration certificate must, at the request of the authorities free of charge to send to the expert institution drug samples, pharmaceutical substances, test strain of microorganisms, cell cultures, samples of substances that are needed for quality control of medicines. Now this expertise is engaged in fsbi “Scientific center of expertise of medical application products”, Ministry of health.

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