Toxicological evaluation full application required:
1 June 2015 onwards for any medicinal product newly introduced into shared manufacturing facilities.
Before 1 December 2015 for medicinal products.
Before 1 June 2016 for veterinary medicinal products
Cross-contamination in shared facilities. NEW
EMA “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities” has changed criteria to assess cross-contamination risks in shared facilities.
Now specific and relevant toxicological data have to be used to recalculate exposure limits, in order to define if a product can be manufactured in a shared equipment, manufacturing line or even in the same premises than others.
We offer tailored services in this area including:
- Risk assessment for the introduction of a new API in an existing plant or for the re-evaluation of existing shared premises.
- Toxicological reports supporting NOAEL and related data as the basis for PDE/ADE calculations. Reports are reviewed and signed by a qualified expert toxicologist.
- Update the cleaning validation policy with the toxicological criteria.
- Cleaning validation protocols and reports.
- Cleaning procedures optimisation: performance and use of water.