Abstract
Background: High-performance liquid chromatography is one of the most used analytical
techniques in quality control in the pharmaceutical industry. Since it is a complex technique, it needs
good practices that can contribute to compliance with regulatory requirements.
Objective: This study aims to establish a diagnostic tool for Good Chromatographic Practices (GCP)
for the self-assessment of a Quality Control Laboratory (QCL).
Methods: The research was carried out on scientific bases, pharmaceutical legislation, as well as
guides published by manufacturers.
Results: Seven axes of action were identified: implementation, management, and continuous improvement
of GCP in the laboratory; GCP in the installation, operationalization, qualification, and
validation processes of the equipment and software; GCP in processes related to data management,
including guidelines regarding access, generation, integrity, and traceability; GCP related to the management
and use of consumables; GCP related to handling, maintenance, analytical and operational
troubleshooting; GCP in the processes of preparation, use, and storage of analytical solutions and reagent
solutions; and GCP related to the acquisition and processing of standards, samples, and results.
These axes resulted in a diagnostic tool with 124 questions.
Conclusion: The application of the GCP diagnostic tool provides the mapping of the routine and procedures
related to the execution of the HPLC technique for quality control in the pharmaceutical industry,
contributing to meeting regulatory requirements.
Keywords:
Chromatography, good chromatography practices, pharmaceutical sector, diagnostic tool, high-performance liquid chromatography, quality control.
Graphical Abstract
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