USP: Analytical Instrument Qualification Stimuli published for Comments
Recommendation
Tuesday, 4 October 2022 13.00 - 16.30 h
Register now for ECA's GMP Newsletter
Since the beginning of 2022, the stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation over the Life Cycle- PF 48(1)" has been published for comments on the USP Pharmacopeial Forum website. Comments and observations on this draft may be submitted until 31 March 2022.
The current draft is divided into the following chapters:
- Introduction
- Relationship between <1220> and <1058>
- AIS Qualification and "Fitness for Purpose" of an Analytical Procedure
- Qualification of an AIS
- AIS Life Cycle Qualification Process
- Target Measurement Uncertainty and Fitness for Intended Use of an AIS
- Summary
- References
The stimuli document "Analytical Instrument and System (AIS) Qualification, to support Analytical Procedure Validation Over the Life Cycle - PF 48(1)" can be consulted and commented on after registration on the Pharmacopeial Forum website.
Related GMP News
21/09/2022
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