Four JP Drafts Related to Chromatography Published for Public Comments

Recommendation

19-21 October 2021

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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.

Live Online Training: Validation of Analytical Test Procedures & Measurement Uncertainty 19-21 October 2021