Analytical Equipment Qualification


Laboratory instruments are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst’s objective is to consistently obtain reliable and valid data suitable for the intended purpose.

Depending on the applications, users validate their procedures, calibrate their instruments, and perform additional instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify their instruments.

Our experts qualify your laboratory instruments using USP General Chapter <1058> on Analytical Instrument Qualification. Competing opinions exist regarding instrument qualification and validation procedures and the roles and responsibilities of those who perform them.

Consequently, various approaches have been used for instrument qualification, approaches that require varying amounts of resources and generate widely differing amounts of documentation. The qualification process will depend on the complexity and intended use of the instrumentation. This approach emphasizes AIQ’s place in the overall process of obtaining reliable data from analytical instruments.

We have experience with executing verification/qualification documents on various laboratory instruments and systems. We have also completed analytical instrument qualification projects for pharmaceutical companies.

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