New CPMP Guideline on Impurities in Pharmacopoeial Substances

GMP News No. 444

2 August 2004

NewCPMP Guideline on Impurities in Pharmacopoeial Substances

In April 2004, EMEA's Guideline on Control of Impurities ofPharmacopoeial Substances: Compliance with the European PharmacopoeiaGeneral Monograph "Substances for Pharmaceutical Use" andGeneral Chapter "Controls of Impurities in Substances forPharmaceutical Use" came into force (CPMP/QWP/1529/04).

This guideline was created due to the fact that some API monographs ofthe European Pharmacopoeia - so-called 'old' monographs - are outdated asto their specifications regarding impurities (mostly 'relatedsubstances'), i.e. they are not in compliance with the currentregulations, e.g. the General Ph.Eur. Monograph 'Substances forPharmaceutical Use' or the ICH Guideline on Impurities ICH Q3A(R). At thesame time it is absolutely necessary that specific API monographs existthat take the current state of the art and knowledge into account.

For this reason, the new guideline suggests that the process ofrevising the 'old' monographs should be carried out simultaneously by theEDQM (European Department for the Quality of Medicines) and by theregistration authorities.

In this context it is planned that the European Pharmacopoeia continuesits ongoing revision programme, possibly setting priorities for individualsubstances. The 'Certificate of Suitability' (CEP) must not be issued anymore if the corresponding monograph has not yet been updated with regardto the limits for impurities.

In parallel to this, the registration authorities have to check forevery application dossier whether the API monograph mentioned therein isup to date, and if not, whether the - in this case necessary - additionalspecifications on impurities have been included. Moreover, the EuropeanPharmacopoeia has to be informed that the API monograph in question needsto be revised.

You can download the complete CPMP document by clicking here.


Dr Günter Brendelberger

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