Four JP Drafts Related to Chromatography Published for Public Comments
Recommendation
Tuesday, 17 June 2025 9 .00 - 15.30 h
Suitable analytical methods to assess AAV quality during development and manufacturing
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
11.06.2025USP informs about Monographs affected by the Revision of NMR Chapters <761> and <1761>
28.05.2025FDA Warning Letter for Chinese Manufacturer: Inadequate Testing and Stability Program Deficiencies
15.05.2025Update of USP Chapter <1099> on Content Uniformity in Large Samples
15.05.2025USP Education Webinar on <1058>