Assessment of the Suitability of Reference Standards for Their Intended Use

The issue of confirming the suitability of reference standards (hereinafter “RS”) for their intended use is highly relevant. Some pharmaceutical manufacturers, in accordance with quality control methods approved in Ukraine, require the use of working reference standards when carrying out state quality control of medicinal products. However, it is crucial to evaluate the provided working reference standards in terms of their suitability for testing. In accordance with the requirements of DSTU EN ISO/IEC 17025:2019 and the WHO, each laboratory is responsible for the correct use of RS, ensuring the metrological traceability of RS within the calibration chain, and obtaining reliable test results for medicinal product samples.

To standardize approaches to state control carried out by authorized laboratories, the State Service of Ukraine on Medicines has developed and made available for use the “Instructions for Verifying the Suitability of Calibration Standards for Their Intended Use” and three annexes thereto, which were developed taking into account the comments and recommendations of authorized laboratories, including the State Research Laboratory for Drug Quality Control at the State Institution «Marzieiev Institute for Public Health of the National Academy of Medical Sciences of Ukraine.»

On July 3, 2026, at the State Research Laboratory for Drug Quality Control, in accordance with the requirements of DSTU ISO 9000:2015, an operational meeting was held titled “Analysis of Quality Management System Processes/Subprocesses Based on Evaluation Criteria,” during which the issue of implementing the State Service of Ukraine on Medicines and Medical Devices’ new Instructions on assessing the suitability of medical devices for their intended use was discussed. A decision was made to develop a new version of the laboratory’s Standard Operating Procedure for reference material management, taking into account the requirements of the aforementioned Instruction, to conduct staff training, and to authorize laboratory specialists to perform this new type of work.

Note that when providing working reference materials to the laboratory, you must submit: a certificate of certification/calibration for the working reference standard (hereinafter “WRS”) and all relevant information, including raw data (details about the primary reference material used for certifying the WRS; the calibration procedure; the certified value of the WRS; the uncertainty of the certified value of the WRS; solution preparation procedures; data on the number and accuracy of repeat measurements; data from printouts and calculations; samples of spectra, graphs, and chromatograms; formulas for calculating the certified value and the uncertainty of the certified value), which would allow for the confirmation and verification of the suitability of this WRS for obtaining reliable results.

(date of publication on the website: 06.07.2026)