USP: Analytical Instrument Qualification Stimuli published for Comments
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
05.11.2026Eurachem Publishes Webinar Recording on the Fitness for Purpose of Analytical Methods Guide
05.11.2026Recent Publications Highlighting Topics to be Discussed at PharmaLab 2026
05.11.2026Meet the AQCG Board Members at PharmaLab 2026
05.11.2026FDA Warning Letter: When Test Procedures Allow Retesting Until an Acceptable Result is Obtained
21.10.2026EMA Updates Information Page on Bioequivalence Guidelines
21.10.2026BP Publishes new Draft Texts