International guidelines are emphasizing on the risk assessment approaches for cross contamination (VICH GL 18, ICH Q3C) of one drug to another in shared manufacturing facilities to calculate health-based exposure limits in Active Pharmaceutical Ingredients (APIs) and intend to cover safety for human and veterinary medicinal products
SteerOn Services and Capabilities
- ➤Expertise in calculating PDE/OEL for cleaning validation processes which involves
- ❖Hazard identification.
- ❖Identification of critical effects (CI’s).
- ❖Determination of NOAEL of the findings that are considered to be critical effect.
- ❖ Use of several adjustment factors to account for various uncertainities.
- ➤ If toxicological data / literature is scarce and NOAEL value is unavailable, our experts read-across data from surrogate compound or use (Q)SAR data as applicable to arrive at feasible PDE value.
- ➤Dossier prepared is on time and audit ready.
- ➤Our Dossier is compliant with the international guidelines.