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AAPS PharmSciTech. 2004 March; 5(1): 151–158.
Published online 2004 April 2. doi:  10.1208/pt050122
PMCID: PMC2784854

Qualification of analytical instruments for use in the pharmaceutical industry: A scientific approach


The purpose of the use of analytical instruments is to generate reliable data. Instrument qualification helps fulfill this purpose. No authoritative guide exists that considers the risk of instrument failure and combines that risk with users' scientific knowledge and ability to use the instrument to deliver reliable and consistent data. In the absence of such a guide, the qualification of analytical instruments has become a subjective and often fruitless document-generating exercise.

Taking its cue from the new FDA initiative, “Pharmaceutical GMP's for the 21st Century,” an efficient, science- and risk-based process for AIQ was discussed at a workshop on analytical instrument qualification. This report represents the distillate of deliberations on the complicated issues associated with the various stages of analytical instrument qualification. It emphasizes AIQ's place in the overall process of obtaining quality reliable data from analytical instruments and offers an efficient process for its performance, one that focuses on scientific value rather than on producing documents. Implementing such a process should remove ambiguous interpretations by various groups.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.
1. US Food and Drug Administration.Guidance for Industry: Bioanalytical Method Validation. US Dept of Health and Human Services, Food and Drug Administration; May, 2001.
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3. International Conference on Harmonization. ICH Q 2A: Text on Validation of Analytical Procedures.Federal Register. 1995;60 FR 11260.
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Articles from AAPS PharmSciTech are provided here courtesy of American Association of Pharmaceutical Scientists