Setting Tolerances for Instrument Qualification USP Chapter <1058>

  • Horacio N. Pappa
  • Kim Huynh-Ba
Part of the Biotechnology: Pharmaceutical Aspects book series (PHARMASP, volume XII)


Abstract Qualification of analytical instruments has been a complex undertaking, not because the process of qualifying instruments is complex, but because several opinions abound on how to perform a successful qualification. Recently, the United States Pharmacopeia issued General Chapter <1058> to provide guidance for Analytical Instrument Qualification (AIQ). The draft chapter has been published in Pharmacopeial Forum (latest in PF 32:6) and has gone through multiple cycles of public comments. The chapter is scheduled to become official in 2008 (USP 31). The purpose of this chapter is to provide general guidance for the qualification of analytical instrument establishing a common terminology and defining roles and responsibilities of those associated with an instrument’s qualification.


Preventive Maintenance Design Qualification System Suitability Test Instrument Qualification Qualification Stage 
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Copyright information

© American Association of Pharmaceutical Scientists 2010

Authors and Affiliations

  • Horacio N. Pappa
    • 1
  • Kim Huynh-Ba
    • 2
  1. 1.United Stated PharmacopeiaRockvilleUSA
  2. 2.PharmalytikNewarkUSA

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