What is it about?

This article deals with the identification, indication and experience of Good Chromatographic Practices (GCP) in Quality Control Laboratories in the pharmaceutical industry. This identification occurs through the GCP diagnostic tool that is presented, whose objective is to provide the reader with technical subsidies, based on an in-depth review of academic, technical and regulatory literature. In this way, the reader will be able to optimize the chromatographic processes of their laboratories in line with contemporary pharmaceutical legislation, maximizing the efficiency of the technique and experiencing the basic principles of data integrity that have been requested by regulatory agencies. The Diagnostic Tool approaches the concept of Good Chromatographic Practices from the process of acquiring a chromatographic system to the process of evaluating results, covering all critical stages related to the preparation of solutions and samples.

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Why is it important?

The successful execution of a chromatographic test by a pharmaceutical quality control laboratory guarantees that a given medicine or active pharmaceutical ingredient is released within the standards required by regulatory agencies. For this execution to be successful, it will depend on good practices that will contribute to the correct exercise of the technique, whether through the appropriate use and management of hardware and software. Therefore, a Good Chromatographic Practices diagnostic tool is important because it contributes to the adequate execution of the technique in accordance with what is required by contemporary regulatory legislation.


The perspectives in relation to this article are to encourage discussion in relation to Good Chromatographic Practices, as well as to provide executors of the technique and managers of Pharmaceutical Quality Control Laboratories with indications on how to achieve the efficiency of the technique in accordance with contemporary regulatory legislation. .

Rodolpho Guilherme Menezes Gama
Fundação Oswaldo Cruz - FIOCRUZ

Read the Original

This page is a summary of: A Diagnostic Tool for Good Chromatographic Practices Applied to HPLC in Pharmaceutical Quality Control, Current Pharmaceutical Analysis, September 2023, Bentham Science Publishers,
DOI: 10.2174/1573412919666230823140503.
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