USP: Analytical Instrument Qualification Stimuli published for Comments

Recommendation

22/23 February 2024
Munich, Germany

API Regulatory Starting Materials
Definition, Manufacture, Assessment and handling post-approval Changes

Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft may be submitted until 31 March 2022.

The current draft is divided into the following chapters:

• Introduction
• Relationship between <1220> and <1058>
• AIS Qualification and "Fitness for Purpose" of an Analytical Procedure
• Qualification of an AIS
• AIS Life Cycle Qualification Process
• Target Measurement Uncertainty and Fitness for Intended Use of an AIS
• Summary
• References

The stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation Over the Life Cycle - PF 48(1)" can be consulted and commented on after registration on the Pharmacopeial Forum website.