6/7 June 2023
As of early September 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process" has been posted on the USP Pharmacopeial Forum website for comment. Remarks and comments on this draft may be submitted until November 30, 2022.
This draft is divided into the following chapters and subchapters:
You can get to and comment the Stimuli document "Analytical Instrument and System (AIS) Qualification: The Qualification Life Cycle Process" after a one-time registration on the Pharmacopeial Forum website.
Here you can also view the previous Stimuli articles on "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" and "Measurement Uncertainty Evaluation Relevant to Analytical Instrument and System (AIS) Qualification - The Role of Measurement Uncertainty Concepts within the AIS - PF 48(2)", which were available for comments earlier this year.