GxP Compliance & Safety

In May , Revision 2 of the ICH Q3D guideline on elemental impurities in medicinal products for human use was published. The new revision has been adopted by the Regulatory Members of the ICH Assembly, although its effective date is set for September this year.   Main changes   1. Correction of PDEs: New PDEs […]

ICH Q3D   The first version of the ICH Q3D guidance was published in 2016, to control elemental impurities in medicinal products for human use within acceptable limits. For veterinary medicinal products, it was recently published in early 2020. The presence of elemental impurities in pharmaceuticals has traditionally been monitored by the so-called heavy metal […]

Impurities are defined in ICH Q6A guideline as “Any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product. The impurities in drug products can be originated not only in the drug substance or inert ingredients used for formulating a drug product; […]

On February 2020 the EU published that titanium dioxide must be classified as carcinogen if inhaled (Carc. 2, H351 (inhalation) in certain powdered forms under the CLP Regulation. Moreover, on May 2021 the European Food Safety Authority (EFSA) published an updated safety assessment of the food additive titanium dioxide (E 171) concluding that titanium dioxide can […]