New Technical Guide of the European Pharmacopoeia for the Elaboration of Monographs published

GMP News No. 695

GMP News
23 March 2006
 
New Technical Guide of the European Pharmacopoeia for the Elaboration of Monographs published
 
The European Directorate for the Quality of Medicines (EDQM) now published the Technical Guide for the Elaboration of Monographs, 4th Edition – 2005, which was already announced some time ago. The Technical Guide is available as a free download on the EDQM website (http://www.pheur.org/site/page_589.php).

The document is supposed to help authors draft European monographs. In addition, it is also meant to be a communication means for users of the European Pharmacopoeia. Moreover, the technical guide can be used as a general guideline for preparing registration files.

The guide refers to existing requirements of the Pharmacopoeia in many places, as for instance to the general chapters:

  • 5.12 Reference Standards
  • Substances for the Pharmaceutical Application (2034)
  • 5.10 Control of Impurities
  • 2.2.46 Chromatographic Separation Procedures

An important part addresses the validation of analytical methods where the two ICH documents Q2A and Q2B were integrated completely. For some methods like optical rotation, UV, AAS, DC or titration the practical implementation of ICH requirements are substantiated per method at the end.

This new EDQM document is tremendously important for those who work in labs in the pharmaceutical industry and deal with pharmacopoeia specifications for APIs and excipients in development or on a day-to-day basis.


For those who work in the area of incoming goods control in quality control units, the European Compliance Academy offers the Education Course „Quality Control of Raw Materials" on 19-20 June 2006 in Barcelona, Spain.

This course will focus on the requirements of the Pharmacopoeias (Ph.Eur. and USP) and introduce the draft of the USP general chapter <1226>, entitled „Verification of Compendial Methods."

Relative to this chapter the ECA also organises a webinar with Dr. Joachim Ermer, sanofi-aventis on 18 May. Please click here to read more about the webinar:

 

 

Author:
Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

 

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