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

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.

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