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