EDQM Clarification for Products outside the Scope of ICH Q3D

The ICH Q3D Guideline, which was published in December last year, applies to most types of medicinal products for human use (with the exception of phytopharmaceuticals, radiopharmaceuticals, vaccines, blood/plasma derivatives etc.); however, it does not apply to medicinal products only used for veterinary purposes (they are not expressly specified as outside of the scope of the guideline, however the calculation of the value limits is based exclusively on products for human use). At the start of August, the EDQM published a press release ("Ph. Eur. Policy on Elemental Impurities - Clarification for products outside the scope of the ICH Q3D Guideline") to clarify how it deals with these products, particularly veterinary medicinal products.

On 28 April 2015, the EDQM published a press release ("Ph. Eur. Policy on Elemental Impurities") announcing that the reference to wet chemical testing for heavy metals, as described in chapter 2.4.8, would be deleted from the relevant pharmacopoeia monographs. In the same notification, the Directorate pointed out that chapter 5.20 will be replaced by a verbatim copy of the ICH Q3D Guideline and the general monograph "Pharmaceutical Preparations" (2619) will contain a reference to chapter 5.20.

The new notification from August of this year states that the cross-reference to chapter 2.4.8 will only be deleted from monographs on substances for human use and for human and veterinary use, but not from monographs on substances for veterinary use only. This means that for the latter, wet chemical test methods can still be used. However, the EDQM links using this method with stricter obligations: The pharmaceutical manufacturer must verify the suitability of the (actually outdated and inaccurate) test methods as well as describe and justify a plausible control strategy using risk management principles as per ICH Q9 or ICH Q3D. This is then part of the authorisation dossier and the subject of the test by the assessor of the licensing authority.

This regulation in the EDQM press release is certainly beneficial for manufacturers of veterinary medicinal products, for whom the instrumental effort of carrying out metal analyses are not worthwhile. However, as described above, the effort to justify using standard analytical methods is considerably larger than before the publication of ICH Q3D.