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Elemental Impurity Analysis In Pharmaceuticals – The Road To Implementation Of Ich Q3d: A Butterworth Labs White Paper


Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance document, Q3D, reached step 4 in December 2014, meaning the final draft is recommended for adoption to the regulatory bodies of the European Union, Switzerland, Japan, USA and Canada.


Since then, the United States Pharmacopeia (USP) announced in March 2015 that 1st January 2018 will be the effective date for General Chapter <232>. A revised version of this chapter has been published in the Second Supplement to USP 38-NF 33 and became official on 1st December 2015. This version contains limits for 15 elements that align with the ICH Q3D Step 4 document. The existing chapter <231> detailing the current colorimetric methods will remain effective until the 2018 date, however, early adoption of <232> is allowable under revised General Notices Section 5.60.30.

From a European perspective, the Committee for Medicinal Products for Human use (CHMP) set an implementation date of June 2016 for new marketing authorisations and December 2017 for all drug products on the EU market to comply with the ICH guidelines. Following this, the European Pharmacopeia (Ph.Eur.) Commission announced its implementation strategy in April 2015, choosing to reproduce verbatim the ICH Q3D guideline in the Ph. Eur. chapter 5.20. References to the existing heavy metals testing Chapter 2.4.8 will be removed to align with the publication of the 9th edition of the Ph. Eur. due for implementation on 1st January 2017. Chapter 2.4.8 will remain applicable until ICH Q3D comes into force for a given formulation.

So with the June 2016 date fast approaching for compliance of new marketing authorisations in the EU, what should manufacturers be doing in order to prepare themselves for compliance? These are the precise parameters that will be conferred in this white paper.

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