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Heavy Metals Testing - ICH Q3D

In June 2016 the US Food and Drug Administration (FDA) issued draft guidance for industry on elemental impurities in drug products.  The new guidance provides recommendations to assist manufacturers to comply with the International Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities and the revision of the ‘Heavy Metals Test’ used in the United States Pharmacopeia/National Formulary.  Both of these changes will come into force in 2018.

In addition, from 1 June 2016 the European Medicines Agency (EMA) adopted the ICH Q3D guidance for new marketing authorization applications.  As the Agency’s evaluations form the basis of authorization of medicines in Europe, all manufacturers who are planning to market new drug products in Europe should act now to ensure that they comply with ICH Q3D Elemental Impurities guidance.

We work to ICH Q3D guidelines, helping manufacturers to be ready for the forthcoming new standards.

Using our extensive experience of elemental impurity testing we will guide you through the ICH Q3D and USP <232> and <233> requirements, developing a bespoke package of analysis to ensure that you comply with the recommended ICH Q3D guidelines as required by the appropriate regulatory authority.

Using ICP-MS (Inductively Coupled Plasma Mass Spectrometry) we are able to identify elements by their individual masses and isotopic fingerprints, with detection limits as low as parts per trillion (ppt) in some cases.

We are fully GMP certified for quality control testing of human and veterinary medicinal products (full documentation is available to download on the right of this page).  All Lucideon’s services are undertaken in compliance with EU guidance on GMP as it applies to contract QC testing laboratories.  We are MHRA-inspected and were successfully re-accredited in September 2016.

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Resources

  • White Paper

    Are you Ready for USP <232>/<233>?
    pdf (246 KB)

  • White Paper

    Quality by Design for the Pharmaceutical Industry
    pdf (137 KB)