White Paper: Analytical Instrument Qualification

Current GxP regulations require analytical instruments to be qualified to demonstrate suitability for their intended use. Despite the fact that instrument qualification is not a new concept, and even though companies invest a lot of effort in it, related deviations are frequently cited in inspectional observations and warning letters by the US FDA and other regulatory agencies.

Many validation professionals working in regulated companies are not sure what exactly to qualify or requalify, test, and document. "How much testing is enough?" they ask. For years, there were no clear standards for equipment qualification like those for analytical method validation. The United States Pharmacopeia (USP) has improved the situation by publishing its chapter <1058> on analytical instrument qualification (1). The chapter establishes AIQ as the foundation for data quality and defines its relationships with analytical method validation, system suitability testing, and quality control checks. Similar to analytical method validation, the intent of AIQ is to ensure the quality of each analysis before tests are conducted. By contrast, system suitability and quality control checks ensure the quality of analytical results immediately before or during sample analysis.

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