Medical Science
| Open Access |
DOI: Qualification of Laboratory Equipment and Its Significance in The Pharmaceutical Quality Control System
Abdullabekova V. N. , Pharmaceutical Education and Research Institute, Tashkent, Republic of Uzbekistan, Uzbekistan Ganieva H.G. , Office of the “Health Projects Center” of the Ministry of Health of the Republic of Uzbekistan; Doctor of Pharmaceutical Sciences, UzbekistanAbstract
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.
Keywords
Pharmaceutical chemistry, quality control, laboratory equipment
References
World Health Organization (WHO). WHO Technical Report Series, No. 992, Annex 4: Supplementary guidelines on good manufacturing practices: validation. Geneva, 2015.-р. 228
ISPE (International Society for Pharmaceutical Engineering). Baseline® Guide: Commissioning and Qualification, Volume 5, 2nd Edition. Tampa, FL, 2019.-р. 212
FDA (U.S. Food and Drug Administration). Guidance for Industry: Analytical Procedures and Methods Validation – Chemistry, Manufacturing, and Controls Documentation. Silver Spring, 2019. (https://www.fda.gov/media/86387/download)
United States Pharmacopeia (USP). <1058> Analytical Instrument Qualification. USP 45–NF 40, 2017.
ISO/IEC 17025:2017. General requirements for the competence of testing and calibration laboratories. International Organization for Standardization / International Electrotechnical Commission (ISO/IEC), 2017. ISBN 978‑92‑67‑10780‑6. -р.30.
World Health Organization (WHO). Good Practices for Pharmaceutical Quality Control Laboratories. Technical Report Series No. 957, Annex 1. Geneva: WHO, 2010. ISBN 978‑92‑4‑120957‑1. -р. 81.
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Copyright (c) 2026 Abdullabekova V. N., Ganieva H.G.
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