USP: Third Instrument Qualification Stimuli published for Comments
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.
Related GMP News
16.10.2024US FDA Warning Letter: Lab Data Integrity issues
16.10.2024FDA Warning Letter: Component Testing, Validation, and Stability
16.10.2024EDQM publishes New Chapter "Quality of Data" for Comments
16.10.2024USP Chapter <621> Chromatography: Notice of Intent to Revise
15.10.2024Pharmeuropa Text for Comment: HPTLC for Herbal Products
09.10.2024WHO Biowaiver Project Cycle VII (2025) and Results from Cycle VI (2024)