Equipment Qualification: A Systematic Method

Qualification is the process of determining or verifying that services, tools, and support systems can function within parameters for the purposes for which they were designed. It is a component of validation. A crucial component of the pharmaceutical quality system is equipment qualification. Regulatory bodies have been emphasising equipment qualification more recently. The process of certifying equipment begins with its design, which is guided by the functional and user requirements specified. Information on Design Qualification, which determines whether the suggested design of buildings, systems, and equipment is appropriate for the intended use, is provided in the review article. Performance qualification is the last step, which shows that the process will consistently produce an acceptable product under typical operating conditions. Installation qualification is the process of determining whether the equipment is constructed and installed in accordance with the design specification. Operational qualification is the process of challenging the process parameters to ensure that the product meets all requirements.