Consultation on the International Council for Harmonisation Guideline Q3E for Extractables and Leachables
Consultation description
Leachables are chemical entities that migrate from manufacturing components/systems, packaging or delivery device components into a drug product under the established manufacturing and labelled storage conditions. Extractables are chemical entities that are intentionally extracted from manufacturing components/systems, packaging or delivery device components under specified laboratory test conditions and thus are potential leachables.
This guideline presents a holistic framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7). The framework of this guideline follows the principles of risk management as described in ICH Q9.
While the guideline includes materials characterisation and process understanding, its primary purpose is to protect patient safety and product quality through assessment and control of leachables in the drug product. Due to rapid advances in materials engineering, device innovations, new manufacturing paradigms and novel therapeutic modalities, the aim is to provide principles and concepts that are forward looking within the scientific and regulatory landscape.
The MHRA welcomes views on the draft guideline from all UK stakeholders including patients and the public.
You can provide comments and recommendations to the consultation as an individual or on behalf of an organisation (one response per organisation please) using the ICH Public Consultation Comments template and emailing it to ichconsultations@mhra.gov.uk. Please include ‘Q3E consultation’ in the subject line of your email.
Following the consultation, feedback from the stakeholders within the UK and other ICH regions will be reviewed and discussed by the ICH Q3E EWG directly. We do not intend to publish a full response to this consultation, as we are not required to for this type of consultation.
Background
The Medicines and Healthcare products Regulatory Agency (MHRA) became a full member of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) in May 2022. ICH brings together global regulators and the pharmaceutical industry to achieve the harmonised development of safe, effective and high-quality medicines.