The International Council for Harmonisation (ICH) has released the draft guideline ICH Q3E on Extractables & Leachables (E&L), now open for public consultation.
The guideline provides a globally harmonised framework for risk assessment and control of extractable and leachable substances in materials that come into contact with medicinal products. It applies to new chemical and biological medicinal products, including cell and gene therapies, as well as combination products consisting of medicinal products and medical devices, covering all dosage forms. in particular, details are provided on:
- Typical workflows for assessing these impurities;
- The various types of studies;
- Determinations for acceptable exposure thresholds and categorisation of potency classes;
We will keep you informed about upcoming developments; in the meantime, we encourage you to review the draft carefully and submit any comments.
For further information, please do not hesitate to contact us.