With new guidelines in place, manufacturers of prescription and over-the-counter products need to determine elemental impurity levels to provide a full risk assessment.
Why Cutaneous Limits
Skin exposure differs from oral or parenteral routes, so dedicated limits are useful.
Risk Assessment
Evaluating raw materials and process contributions supports a defensible control strategy.
Harmonisation
Aligned expectations help manufacturers apply consistent standards.
About This White Paper
This white paper is published by Almac Group and curated by Biotechnology Media Insights, a trusted source for pharmaceutical and biotechnology research, technical guides and industry analysis.