Qualification of Laboratory Equipment and Its Significance in The Pharmaceutical Quality Control System

This article highlights the scientific and practical aspects of qualification of laboratory equipment within the pharmaceutical quality control system. It substantiates that the proper selection, installation, and operation of laboratory instruments are crucial for ensuring the reliability, accuracy, and reproducibility of pharmaceutical analysis results. The article provides a detailed analysis of the internationally accepted stages of laboratory equipment qualification—DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)—their content, and their role within the pharmaceutical quality system. It also examines the classification of equipment into Groups A, B, and C in accordance with ISPE and WHO guidelines, as well as the determination of the appropriate level of qualification required for each group. Furthermore, the importance of qualifying laboratory equipment in compliance with GMP, ISO 17025, USP <1058>, and WHO requirements is substantiated. The scientific and practical foundations for implementing this process in the pharmaceutical industry of Uzbekistan are also presented. The research findings have practical significance for improving the quality system in pharmaceutical laboratories and ensuring reliable analytical results.

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