Gaurav S Kulwant, Dr Swati Rawat, Dr Sunil Jaybhaye, Mr Yogiraj Muley, Mr Sandip Phoke
Institute of Pharmacy, Badnapur, Dist. Jalna, Maharashtra
Abstract
This project focuses on the qualification of laboratory equipment used in the pharmaceutical industry, emphasizing the importance of ensuring reliability, accuracy, and compliance with regulatory standards. The qualification process encompasses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), which collectively verify that equipment operates as intended and meets specified requirements. Through systematic testing and documentation, this project evaluates critical equipment, including spectrophotometers, chromatographs, and balances. By adhering to industry guidelines, such as those set forth by the FDA and ICH, this qualification ensures that laboratory results are reproducible and trustworthy, ultimately contributing to the safety and efficacy of pharmaceutical products. The outcomes of this project highlight best practices for equipment qualification, fostering a culture of quality in pharmaceutical laboratories. Qualification as a part of validation is the task performed to identify or check that utilities, equipment and Ancillary systems are capable of operating within limits for their intended use. Equipment qualification is a key Element in the pharmaceutical quality system. In recent times regulatory agencies are more focusing on Qualification of equipment. Qualification of the equipment starts from design of the equipment based on the User requirement specification and functional requirement specification. The review article provides Information on Design Qualification which is done to identify whether the proposed design of facilities, system And equipment is suitable for intended purpose, Installation Qualification which is done to check whether the Equipment is built and installed in compliance with design specification, Operational Qualification in which the Process parameters shall be challenged to assure that product meets all requirements and finally Performance Qualification to demonstrate that the process will produce acceptable product consistently under normal Operating conditions
Keywords: Qualification, equipment, Regulatory requirement , calibration
Journal Name :
EPRA International Journal of Multidisciplinary Research (IJMR)

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Published on : 2024-11-28

Vol : 10
Issue : 11
Month : November
Year : 2024
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