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White Paper: How to Comply with the 2017 Version of USP <1058>

White Paper: How to Comply with the 2017 Version of USP <1058>
Why is AIQ so important?

Regulated laboratories must demonstrate that the analytical instruments they use are suitable for their intended use, and performing AIQ is the best way to do this. A well implemented AIQ process reduces potential audit risks associated with laboratory instruments and safeguards the data they generate. If the instrument is not performing as expected, the analytical results generated may be invalid.

Evolution of USP thinking on AIQ

The changes to USP <1058> in the 2017 version are significant and require laboratories to fundamentally re-evaluate their AIQ processes, or risk regulatory non-compliance. The 2017 version contains many similarities to the 2008 version, and there is a risk that laboratories make the following erroneous interpretation:

“The changes appear to be small and evolutionary in nature; we already complied with <1058>, so the changes have minimal impact on our laboratory.”

White Paper Download white paper part 2

Download Part 2 of our white paper series to learn how to comply with the 2017 Version of USP <1058>.

How to Comply with the 2017 Version of USP <1058>

Agilent’s white paper series highlights and explains changes in the 2017 version of USP <1058>, so that laboratories realize the impact of the changes and implement appropriate updates to their AIQ processes and procedures (or risk a potential non-compliance in a regulatory audit).

The second white paper highlights how to comply with the 2017 version of USP <1058> by providing information on:

  • Aligning OQ Testing <1058> - with URS requirements
  • Leveraging Instrument Suppliers - in <1058> compliance
  • Compliance Explained - details of URS, DQ, IQ, OQ and PQ requirements
  • OQ and PQ Essentials - how the 2017 <1058> redefines the roles OQ and PQ
  • Actions Required - to be compliant
Related Literature

Part 1: What Has Changed with the 2017 Version of USP <1058>?

Part 3: The Role of Analytical Instrument Qualification in Data Integrity with 2017 USP <1058>

Part 4: What Does Performance Qualification Really Mean?

Download Part 2 of our white paper series to learn how Agilent can help make your lab compliant with USP <1058>.

Please complete the form below to download.