USP: Second Stimuli Article on Instrument Qualification published for Comments
Register now for ECA's GMP Newsletter
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.
Related GMP News
27/09/2023
20/09/2023
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others