Pharmaceuticals - 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In June 2016, the U.S. Food and Drug Administration (FDA) issued draft guidance for industry on elemental impurities in drug products.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 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 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 ensure that they comply with ICH Q3D Elemental Impurities guidance.
Here at Lucideon, our GMP Chemistry department has, to date, helped numerous manufacturers ensure that their drug products comply with ICH Q3D guidelines, enabling them to get their products to market with the assurance that they are fit for purpose.
Using our extensive experience of elemental impurity testing, we will guide you through the ICH Q3D and USP <232> and <233> requirements, developing a customised 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. 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 June 2020. Lucideon’s GMP Laboratories in the UK were also successfully inspected by the FDA (U.S. Food and Drug Administration) in September 2019.