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In June 2016 the US Food and Drug Administration (FDA) issued draft guidance for industry on elemental impurities in drug products.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. While both of these changes will come into force in 2018, it is recommended that pharmaceutical manufacturers who wish to market products in the US make the switch now to avoid post-deadline problems.
In addition, from 1 June 2016 the European Medicines Agency (EMA) adopted the ICH Q3D guidance for new marketing authorisation applications. As the Agency’s evaluations form the basis of authorisation 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.
Pharmaceutical products are required to be tested for heavy metal content as out of specification levels can present a safety risk to the patient. United States Pharmacopeia (USP) regulations have recently been changed with regards to heavy metal testing with the introduction of USP <232> & <233>.
From the start of 2018 the outdated USP <231> limit test for heavy metals, which has been in use for more than a century, will be replaced by individual limits for specific elements as USP <232> with the test methods given in USP <233>.
The FDA is recommending that manufacturers of US marketed drug products follow ICH Q3D guidance and General Chapters <232> and <233> to establish procedures to identify and control elemental impurities (heavy metals) as they provide significant improvements over existing approaches. And, as stated above the EMA has already adopted ICH Q3D guidance for new marketing authorisation applications.
How can we help?
At Lucideon we are now working 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.