USP General Chapter <621> Chromatography: Delay of the Implementation of Two New Requirements
Recommendation
13-15 May 2025
Vienna, Austria
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory
Register now for ECA's GMP Newsletter
The revised USP General Chapter <621> Chromatography is scheduled to be official on 01 December 2022. The Chemical Analysis Expert Committee has now announced that the implementation of the sections titled "Peak Sensitivity" and "Peak Symmetry" under "System Suitability" will be delayed.
In a Notice of Intent to Revise posted on 26 August 2022, it is stated that, based on the comments received, the committee considered that stakeholders may need additional time to evaluate the impact of these two new requirements.
It is intended that the proposed revision to General Chapter <621> will be published as a Revision Bulletin on 28 October 2022. The Chemical Analysis Expert Committee expects "that during the extended period of implementation stakeholders will evaluate existing compendial procedures and submit comments."
More Information is available on the USP-NF Website.
Related GMP News
09.05.2025New ECA Guidance on Sampling and Sample Management
07.05.2025Public Consultation on ICH M13B Guideline on Bioequivalence launched in Switzerland
07.05.2025BioPhorum publishes Guidance for ICH Q2(R2) and Q14 Implementation
23.04.2025OTC Drug Production Ceased after FDA Warning Letter
23.04.2025EMA publishes Draft of ICH M13B Guideline on Bioequivalence
16.04.2025EMA publishes four new product-specific Bioequivalence Guidance