Boas Práticas Para Cromatografia Líquida De Alta Eficiência: Uma Abordagem Para O Controle De Qualidade Farmacêutico

Abstract

The High Performance Liquid Chromatography (HPLC) is one of the most advanced techniques used in quality control laboratories in the pharmaceutical industry due to its high technical versatility. According to several regulatory agencies, it is necessary that a pharmaceutical industry has the authorization to produce and commercialize its products, by complying with Good Manufacturing Practices (GMP) standards. Given that the applicability of HPLC techniques meets the requirements of GMP, it is dazzled that these same techniques have criteria to guarantee the safety, reliability and reproducibility of the data generated, together with the maximization of the performance of the chromatographic systems in a cost- benefit analysis for the pharmaceutical industry, thus evoking the concept of Good Chromatographic Practices (GCP), present since the beginning of the development of chromatographic processes and indicated up to the present day, empirically, by the manufacturers of equipment and consumables chromatography. Identified this opportunity, the present work approaches theoretical and practical concepts of the HPLC techniques. In order to do so, it was adopted as methodology the bibliographical and documentary research in databases of scientific articles, as well as queries to documents originating from the largest manufacturers of HPLC items. Thus, through the discussion of GCP in equipment qualification processes, preparation of samples and solutions used in the tests, the cleaning of HPLC accessories and the data integrity processes generated, it is understood that these are fundamental practices for the pharmaceutical industry adding greater reliability in its processes, culminating in the reduction of costs with maintenance and in full compliance with the requirements of the regulatory agencies. It is therefore advocated that the GCP approach be a reality within the quality control laboratories of the pharmaceutical industries, following harmonized precepts and normalizing the knowledge of users, since they are justified as indispensable tools within their routines of activity.