Is your company manufacturing different medical products in shared facilities? Then there’s an ever-present risk of potential cross-contamination. Cross-contaminated medicines may lose their effects or worse, lead to risks for patients or animals.
Since the end of 2015, new GMP regulations force companies to undertake a risk analysis of manufactured products based on a toxicological value. To identify the risks posed, health-based limits through the derivation of a safe threshold value should be employed. Companies should document all possible risks in toxicological reports, through the structured scientific evaluation of all available pharmacological and toxicological data. The new rules will also apply to veterinary medicines from June 2016 onwards.
Small and medium-sized laboratories often don’t employ toxicology experts and need to outsource these reports. QbD provides your company with all the required toxicological reports to guarantee your compliance with the new GMP regulations.
A toxicology report for any API
Toxicology reports are based on the toxicological properties and pharmacology of the specific active pharmaceutical ingredient (API). In the toxicology report, we address:
- Hazard identification
- Identification of critical effects
- Determination of the no-observed-adverse-effect level (NOAEL) of the findings..
- Application of several adjustment factors to account for various uncertainties.
- PK correction
Interested in a sample report? Download it here.