JP Drafts Related to Chromatography for Public Comments - Updated Version

Recommendation

25-27 April 2023

Leachables and Extractables - Live Online Training
Testing & Assessment from Packaging to Single Use

We recently reported that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) had published the following four Japanese Pharmacopoeia (JP) drafts of General Tests and General Information related to Chromatography:

• 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 agency has now released a slightly modified version of the draft of new General Test “<2.00> Chromatography”. The PMDA states:

"Due to the progress in harmonization of G-20 Chromatography, the description of line 420-423 in the JP draft were changed as follows:
Before the change: To verify the suitability of the method under the new conditions, assess the relevant analytical performance characteristics potentially affected by the change.
After the change: To verify the suitability of the adjusted pharmacopoeial procedure, assess the relevant analytical performance characteristics potentially affected by the change."

The drafts are available on the PMDA's website. Comments can be submitted until November 30, 2021.