Book by 30 June 2026 and get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
USP: Analytical Instrument Qualification Stimuli published for Comments
Recommendation
18 June 2026
Regulatory framework, interfaces and practical implications
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
03.06.2026EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026
03.06.2026FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem
28.05.2026WHO Working Document on Bioequivalence open for Public Consultation
21.05.2026LCGC Article on Analytical Procedure Lifecycle Approaches