USP: Second Stimuli Article on Instrument Qualification published for Comments
Recommendation
Thursday, 3 September 2026 9 .00 - 17.00 h
Establishment, Use and Maintenance of Analytical Reference Substances
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
As of early March 2022, the stimuli document "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)" has been posted on the USP Pharmacopeial Forum website for comment. Comments and remarks on this draft can be submitted until 31 May 2022.
This draft is divided into the following chapters:
- Introduction
- AIS Uncertainty Contributions to the Analytical Procedure
- Evaluation of Measurement Uncertainty with Focus on UAIS
- Example - HPLC-UV Assay Method
- Conclusion
- References
The Stimuli document can be checked and commented on after a one-time registration on the Pharmacopeial Forum website.
Here you can also review the Stimuli article on "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" and comment on it until 31 March 2022 - as recently reported.
Related GMP News
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests
04.08.2026BioPhorum Publishes a Roadmap for QC Sample Test Execution
04.08.2026USP AISQ Virtual Workshop: ECA AQCG Board Members Contributed as Speakers
04.08.2026Several FDA Warning Letters and Untitled Letters on Asbestos Testing of Talc in OTC Drug Products