Metrological Requirements to Measuring Equipment (Review)

Introduction. Qualification of equipment is one of the crucial aspects of quality assurance of medicinal products that ensures consistency of metrological characteristics. Elaboration of local guidances on qualification of measuring instruments, and harmonisation of the qualification procedure with the requirements of the European and American regulations will help to improve the quality of medicinal products manufactured in Russia and to facilitate their competitiveness on the global pharmaceutical market.

Text. The aim of this review is to analyse the Russian regulatory framework regarding the consistency of metrological characteristics of measuring equipment used in the pharmaceutical industry. The article contains information on the special aspects of confirmation of compliance of equipment to the metrological requirements stated in various regulatory documents in force in the Russian Federation.

Conclusion. The article demonstrates the ambiguity of interpretation of the Russian regulatory framework and European quality recommendations regarding metrological requirements to measuring equipment. Elaboration of the local guidance harmonizing metrological requirements to equipment will help to focus on the result and the quality of medicinal products, and to eliminate the ambiguity of interpretation of the Russian regulatory framework.

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