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![]() MELINTE, Elena, TUDOREAN, Arina, ŞTEFĂNEŢ, Tatiana. The importance of validating analytical methods. In: Revista de Ştiinţe ale Sănătăţii din Moldova, 2022, nr. 3 An.1(29), p. 500. ISSN 2345-1467. |
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Revista de Ştiinţe ale Sănătăţii din Moldova | ||||||
Numărul 3 An.1(29) / 2022 / ISSN 2345-1467 | ||||||
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Pag. 500-500 | ||||||
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Background. Quality control of raw materials, intermediates, and finished products plays an important role in the quality assurance system for medicinal products. The production of quality medicines requires the use of validated analytical methods. Objective of the study. Studying the specialized bibliography (ICH, FDA, USP, Eur. Ph., EPA, GMP) and assess the main issues concerning the importance of validation of analytical methods used in quality control of medicinal products. Material and Methods. Validation of analytical methods is carried out both when developing a new analytical method and when modifying an existing method. The practical value of validation lies in the fact that during the development of new methods, shortcomings can be detected at an early stage, allowing considerable refinement at an early stage. Results. A validated process is a procedure or method for which accuracy and precision have been explored and documented, but for which specificity and sensitivity, as well as other parameters, have been examined to increase analytical confidence. Therefore the main parameters that are the focus of validation are specificity, sensitivity, accuracy, repeatability, linearity, reproducibility, precision and robustness. Validation is therefore an important step in determining the reproducibility and reliability of the method, as it can confirm whether the method is suitable to be used for a particular system. Conclusion. Validation methodology aims to demonstrate that an analytical method is fit for the purpose and that the performance characteristics of the method under consideration, as established by laboratory studies, satisfy the requirements for the method to be applied. |
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Cuvinte-cheie substance, methods of analysis, validation, substanţă, metode de analiză, validarea |
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