The difference between verification and validation of analytical methods in the pharmaceutical industry

Jovanova, Suzana and Serafimovska, Tijana and Darkovska-Serafimovska, Marija and Trenova, Maja and Ivanova, Tanja (2022) The difference between verification and validation of analytical methods in the pharmaceutical industry. Macedonian Pharmaceutical Bulletin, 68 (1). pp. 185-186. ISSN 1409-8695

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Abstract

To submit a dossier for marketing authorization to the Regulatory affairs, a product owner must provide Common Technical Documentation (CTD) containing a pharmaceutical product characteristics, manufacturing, quality control, safety (nonclinical), and efficacy (clinical) testing results before gaining approval for market access. Although quality improvement measures in the quality control laboratory have been enormous in recent years, especially due to improved handling of the validation and verification of the method performance, they often still differ widely from laboratory to laboratory. Much of what has been published on this topic is difficult to apply in routine laboratories due to complex statistics. The result is that
method validation is often implemented incorrectly, which leads to false conclusions about the performance of the method, potentially compromising patient safety. The purpose of qualification, validation and verification is to generate reliable data for the products tested, resulting in the delivery of quality drug products to the patients. Therefore, the aim of this research is to emphasize the differences between verification and validation of analytical methods in the pharmaceutical industry.

Item Type:	Article
Subjects:	Medical and Health Sciences > Other medical sciences
Divisions:	Faculty of Medical Science
Depositing User:	Marija Darkovska-Serafimovska
Date Deposited:	02 Feb 2023 07:26
Last Modified:	02 Feb 2023 07:26
URI:	https://eprints.ugd.edu.mk/id/eprint/31173

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