Analytical Instrument Qualification AIQ is the documented evidence to prove that an instrument performs suitably for its intended purpose. The USP 32 NF 27 has come up with recent chapter on AIQ is a scientific approach and gives guidance of the following: The approach of AIQ The criteria to categorize the instrument for assessment of qualification needs The extent of qualification depending upon the category of instrument The documentation required. AIQ, Analytical method validation, system suitability tests, and quality control check samples are described as the four critical components involved in the generation of reliable and consistent data. It is the responsibility of user to prepare a User Requirement Specification (URS) which would suffice all the needs as per the requirement for analysis. The manufacturer shall be responsible for preparing the design specification. Categorization of the instruments: As per the USP all the laboratory instruments can be ca...
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