The uncertainty concept is a recognized scientific basis for the quality assurance of analysis results. Under the ISO 17025 guide, compliance with which becomes mandatory for official medicine quality control laboratories, uncertainty assessment is necessary for any quantitative determination and, therefore, extremely relevant for medicine manufacturers.
That is why State Enterprise “Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines” in collaboration with Quality Laboratory LLC launched a series of workshops aimed at implementing the uncertainty assessment and making sound decisions on compliance with specifications in a medicine quality control laboratory. On February 24-25, 2021, the first workshop entitled “The concept of measurement uncertainty in pharmaceutical analysis. The approach of the State Pharmacopoeia of Ukraine” was held.
The author and presenter of the workshop is Dmytro Leontiev, Sc.D., Deputy Director of Science, Head of the Department of Validation and Reference Standards at State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines", Head of Research Areas of the State Pharmacopoeia of Ukraine (SPhU) on Metrological Assurance of the Quality of Analysis Results, Reference Standards, and Verification of Analytical Procedures, Professor of the Department of Pharmaceutical Chemistry at National University of Pharmacy.
Dr Leontiev relies on his more than 20-year experience in creating the SPhU metrological system developed jointly with prof. Oleksandr Gryzodub. The metrological system allowed its authors to successfully develop the system of pharmacopoeial and working reference standards, the proficiency testing program, approaches to validation of analytical procedures and tests, etc.
The workshop was attended by 89 people, including specialists from the State Service of Ukraine on Medicines and Drugs Control, the Medicines and Medical Devices Agency of the Republic of Moldova, pharmaceutical factories of Ukraine and Moldova, SE "Pharmacopoeial Center", National University of Pharmacy and I. Horbachevsky Ternopil National Medical University.
The workshop focused on understanding the specifics of applying the uncertainty concept in the pharmaceutical sector, considering the internationally adopted standardization rules for medicines. The pharmacopoeial rule for making decisions on compliance with specifications and its consistency with the non-pharmaceutical sector approaches is covered. The Ph. Eur. and SPhU approaches to setting the target uncertainty for basic pharmaceutical tests (assay for substances and finished drug products, dissolution, uniformity of dosage units, and related substances) are analyzed. The principle of consistency between the capabilities of the analysis method and the assay specification width is discussed. The definition of "normal analytical pharmacopoeial practice" and recommendations of Ph. Eur. and SPhU to standardize the target uncertainty for sample preparation and measurements are given. The SPhU procedure for the uncertainty prognosis and examples for its use for various quantitative procedures are shown. Examples of metrologically incorrect analytical procedures, including those from the monographs of Ph. Eur. and USP, and corrective measures are provided.
The staff of State Enterprise “Ukrainian Scientific Pharmacopoeial Center for Quality of Medicines” heartily congratulates Dmytro Leontiev on the brilliantly held seminar and wishes him new creative ideas and all the best.
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