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Heavy Metals Testing - ICH Q3D

In June 2016 the U.S. Food and Drug Administration (FDA) issued draft guidance for industry on elemental impurities in drug products.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 came 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 customized 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. Lucidedon's GMP Laboratories in the UK were also successfully inspected by the FDA (U.S. Food and Drug Administration) in September 2019.

On Demand Webinars

  • Advancing Vascular Devices Through Innovative Fatigue Testing & Particulate Evaluation

    In this webinar, host Joe Foroughi, Chemistry and Microanalysis Manager at Lucideon, is joined by Dynatek's Director of Global Sales, Kendra Conti. The webinar highlights how various changes in standards have affected the testing landscape for vascular devices and their delivery systems. As OEMs continue to see regulators asking for more data and greater justification in their processes, we look at what the standards are really asking for, and how to best meet the requirements for a variety of devices.

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  • Single Tooth Restorations and Dental Treatments of the Future

    Presented by Anike Bütow, Technology & Strategy Leader at Lucideon, this webinar discusses the challenges and drivers facing the dental industry, with a particular focus on caries.

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  • Wear Testing - Load-Control vs. Displacement-Control

    In the second part of our “What the Standards Don’t Tell You” series, we dig a little deeper into ISO 14243, the wear testing standard for total knee replacements. Not every knee replacement is made equal, nor is every knee system suitable for every patient. How do you know that your design is being tested for its intended application?

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  • Ceramic Forming Techniques

    A wide range of techniques are employed to form ceramic components, with each technique having specific advantages and disadvantages. In this webinar, Richard White and Mike Salt discuss these techniques, and how and why they are chosen, with regards to advanced ceramics.

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  • Cleaning Issues with Additive Manufactured Devices

    While this general topic has been covered in various webinars in the past, here we isolate several key aspects of the problem. The unique porous coated surfaces of new additively manufactured (AM) medical implants have proven to be quite complex and are creating challenges with respect to effective cleaning.

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  • White Paper

    Are you Ready for USP <232>/<233>?
    pdf (247 KB)

  • White Paper

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