New Developments at EP, USP an JP - Divergent Compendial Methods and Harmonisation

Pharmacopoeias are defining normative standards to be followed by the pharmaceutical industry, specifically by laying down monographs for APIs and excipients and corresponding general chapters for specific test procedures like Chromatography (HPLC, etc.) or Dissolution Testing, etc.. In addition, pharmacopoeias are defining many particular requirements for specific dosage forms as tablets or capsules, etc..

Actually some of the most important general chapters are being revised and updated or some texts will be established as completely new chapters:

  • Analytical instrument qualification (AIQ)
  • Elemental impurities
  • Method validation, verification, and transfer
  • Spectroscopic methods (AAS, Fluorescence, Mid InfraRed, NMR, NIR, Raman, and UV-Vis)
  • Dissolution testing

Harmonisation is another big issue. Harmonisation was a request of the pharmaceutical industry, struggling with the unnecessary burden of redundant testing as companies were becoming increasingly operating multinational.

Under the roof of the ICH, the Pharmacopoeial Discussion Group (PDG) and the ICH Q4B Working Group have been dealing for years with the harmonisation of the requirements laid down in the pharmacopoeias of the three ICH regions. The PDG was founded in 1990 comprising representatives from EDQM, MHLW (Japan) and the USP. Its goal is to harmonise monographs for selected excipients and for a number of general chapters of the pharmacopoeias.

The ICH Q4B Expert Working Group (EWG) was established in 2003 and aimed at evaluating all test methods included in ICH Guideline Q6A on Specifications. Test procedures are evaluated whether they are interchangeable, which is defined as follows: "Where such status is indicated, any of the official texts from JP, EP, or USP can be substituted one for the other (appropriately referenced) in the ICH regions for purposes of the pharmaceutical registration / approval process".

The primary benefit of harmonisation for industry is the elimination of redundant testing, not only in the registration / approval process but also in the testing and sampling of APIs and excipients in routine Quality Control.

The ECA is organising a Compliance Update: EP, USP, and JP on 21-22 June 2012 in Prague, Czech Republic. Here new compendial chapters as well as strategies to deal with divergent compendial methods will be discussed.

Dr Günter Brendelberger
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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