5/6 March 2024
The EDQM has announced that the harmonised general chapter Chromatography was signed-off by the Pharmacopoeial Discussion Group (PDG), which brings together the European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP).
In a press release dated 08 November 2021, the EDQM states that during the harmonisation of the text, particular attention was paid to the following aspects:
The approach goes back to joint PDG–industry meeting in 2009, on which the PDG was encouraged to add harmonisation of the three regional chapters on chromatography to the PDG work programme.
The corresponding regional texts are scheduled for publication according to the following dates:
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:
These four drafts have been under public consultation since September.
In addition, the following document was published at the beginning of November:
The drafts are available on the PMDA's website. Comments can be submitted until November 30, 2021.
Further information can be found in the "Briefing on drafts of General Tests and General Information related to Chromatography"