USP: Analytical Instrument Qualification Stimuli published for Comments

Recommendation
Tuesday, 23 September 2025 13.00 - 17.00 h
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.
Related GMP News
23.07.2025New HPTLC Chapter Proposed for The International Pharmacopoeia
22.07.2025AQCG Organises One-Day Track at PharmaLab 2025
22.07.2025ICH publishes Training Materials on Q2(R2) and Q14
22.07.2025AQCG welcomes two new Board Members
22.07.2025Free Webinar on Sampling and Sample Management: Recording & Q&A Document