Good practices for high performance liquid chromatography: an approach to pharmaceutical quality control

Gama R. G. M., Chaves M. H. C.

Keywords: Good Chromatographic Practices. High Performance Liquid Chromatography Quality control, Pharmaceutical industry

Abstract: High Performance Liquid Chromatography (HPLC) is one of the most advanced techniques used in quality control laboratories in the pharmaceutical industry, due to its great versatility. Good Chromatographic Practices (GPC) have a logic similar to that of the Good Manufacturing and Laboratory Practices protocols, coming from national and international regulatory bodies and aimed at the pharmaceutical niche, in order to assist in complying with all these quality standards. GCP are present from the beginning to the end of the development and practice of chromatographic processes and are commonly transmitted, empirically, by chromatographic equipment and consumables manufacturers. Practical HPLC procedures based on theoretical concepts are addressed, based on bibliographic research in databases of scientific articles and also in the consultation of documents from the major manufacturers of HPLC items. The discussion of GCP for the preparation of samples and solutions used in the testing and cleaning of HPLC accessories and consumables brings the understanding that they are fundamental practices for the pharmaceutical industry, adding greater reliability to their processes, culminating in possible cost reduction with maintenance and in full compliance with the requirements of regulatory bodies. Therefore, it is important that the GCP approach becomes a reality within the quality control laboratories of the pharmaceutical industries, so that they follow harmonized precepts for all analysts and users, since these tools are indispensable for reliable results to be produced in the laboratory routine.

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