AN OVERVIEW OF ANALYTICAL METHOD VALIDATION

Umut BESKAN; Sümeyra TUNA YILDIRIM; Evren ALGIN YAPAR

doi:10.22270/ujpr.v5i1.362

Umut BESKAN Department of Analysis and Control Laboratories, Turkish Medicines and Medical Devices Agency, Sıhhiye, Ankara, Turkey.
Sümeyra TUNA YILDIRIM Department of Analytical Chemistry, Faculty of Pharmacy, Erzincan Binali Yıldırım University, Yalnızbağ, Erzincan, Turkey.
Evren ALGIN YAPAR Department of Analytical Chemistry, Faculty of Pharmacy, Erzincan Binali Yıldırım University, Yalnızbağ, Erzincan, Turkey.

10.22270/ujpr.v5i1.362

Keywords:

Medicines, quality, test method, validation

Abstract

In line with the developments in the pharmaceutical field, the product range is constantly being renewed and diversified. New analytical techniques need to be developed and validated for new pharmaceutical products. The validation of an improved method is an internationally recognized scientific requirement, as these validation practices are also indicative of the competence of the analytical laboratory. The method development is a process that ensures the applicability and reliability of the data. The result is a more comprehensive understanding of the standard test methods and a further insight into the connection between test methodology and product quality. It is important to validate an advanced method. Because if the method can not be reproduced, the method is meaningless. Validation is a continuous balance among costs, risks and technical possibilities.