USP: Third Instrument Qualification Stimuli published for Comments

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

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:

• Introduction
• Life Cycle Process Descriptions
  o User Requirement Specifications
  o Vendor Contribution to the Qualification Process
  o Design Qualification
  o Purchase Order
  o Installation Qualification
  o Operational Qualification
  o Performance Qualification
  o Qualification Summary Report
  o Operational Use and System Suitability Tests
  o New Analytical Procedures
  o Ongoing Performance Verification of the Qualified State
• Conflict of Interest Disclaimer
• References

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.