VALIDATION of ANALYTICAL METHODS in A PHARMACEUTICAL QUALITY SYSTEM: AN OVERVIEW FOCUSED on HPLC METHODS

Abstract

Analytical validation has fundamental importance in the scope of Good Manufacturing Practice (GMP) for pharmaceutical products since it establishes scientific evidence that an analytical procedure provides reliable results. However, even with validation guidelines available it is very common to observe misunderstandings in the execution of validation and data interpretation. The misguided approaches of validation guidelines, allied with a disregard for the peculiarities of the analytical techniques, the nature of the sample, and the analytical purpose, have significantly contributed to oversights in analytical validation. This work aims to present a critical overview of the validation process in pharmaceutical analysis, addressing relevant aspects of various analytical performance parameters, their different means of accomplishment and limitations in face of the analytical techniques, the nature of the sample, and the analytical purpose. To help in the planning and execution of the validation process, some case studies are discussed, mainly in the area of high-performance liquid chromatography (HPLC).