USP: Second Stimuli Article on Instrument Qualification published for Comments

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.

Go back

GMP Conferences by Topics