Harmonised General Chapter on Chromatography

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

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).

Harmonised Requirements

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:

• Terminology, definitions and interpretation of chromatograms
• System suitability
• Adjustment of chromatographic conditions
• Quantitation procedures

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:

• Ph. Eur.: July  2022  
• JP: December 2022 
• USP: December 2022

JP Drafts for Public Comments

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)

These four drafts have been under public consultation since September.

In addition, the following document was published at the beginning of November:

• Draft of revised General Information "<G1-2-181> System Suitability"

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"