USP: Analytical Instrument Qualification Stimuli published for Comments
Recommendation
Wednesday, 6 May 2026 9 .00 - 12.30 h
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
23.04.2026Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1
22.04.2026USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)
08.04.2026FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence
01.04.2026FDA Warning Letter - From Garbage Bags with Analytical Records to Pre-signed and Backdated Data
31.03.2026Questions and Answers on System Suitability Tests (SST) - Part 3
31.03.2026Statistical Process Control (SPC) - Survey Result Report now Available