Four JP Drafts Related to Chromatography Published for Public Comments
Recommendation
6/7 May 2025
Challenges and Solutions for Packaging / Devices & Single Use Systems
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
22.04.2025OTC Drug Production Ceased after FDA Warning Letter
22.04.2025EMA publishes Draft of ICH M13B Guideline on Bioequivalence
16.04.2025EMA publishes four new product-specific Bioequivalence Guidance
09.04.2025Missing Tests and Altered Records: FDA Warns Chinese OTC Manufacturer
09.04.2025Pharmeuropa: New Chapter on Evaporative Light-Scattering Detection published for Comment
09.04.2025Pharmeuropa: Four Draft Chapters on Elemental Analysis Published for Comment