Four JP Drafts Related to Chromatography Published for Public Comments
Recommendation
Friday, 17 October 2025 9 .00 - 12.30 h
Register now for ECA's GMP Newsletter
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography.
The following documents have been published:
- Draft of new General Test “<2.00> Chromatography”
- Draft of revised General Test “<2.01> Liquid Chromatography”
- Draft of revised General Test “<2.02> Gas Chromatography”
- Draft of new General Information “<G1-5-181> Control Strategies and Change Control Concepts at Each Stage of Chromatography Lifecycle” (Change Control in Lifecycle of Chromatography)
The four draft documents are available as a PDF file on the PMDA's website. The PMDA also published a Briefing Note in which the key points of these four drafts are summarised.
Comments can be submitted until November 30, 2021. For this purpose, a form for comments has to be downloaded and sent by e-mail after it has been filled in.
Related GMP News
08.10.2025FDA Warning Letter Highlights OOS Handling and Stability Failures
08.10.2025Pharmeuropa: Revision of Residual Solvents Chapter 2.4.24 Published for Comments
08.10.2025USP: Harmonized Chapter <701> Disintegration Adopted
08.10.2025What is the ATP?
01.10.2025Shelf Life vs. Retest Date - What's the Difference?
24.09.2025What is the Difference between Bracketing and Matrixing?