Ensure Cross-Contamination Control and GMP Compliance

The manufacture of medicinal products in shared facilities carries the inherent risk of cross-contamination through the carry-over of active substances or starting materials. To mitigate this, Good Manufacturing Practice (GMP) mandates a rigorous toxicological evaluation to establish health-based exposure limits. SAXOCON provides the specialized expertise required to calculate and document these thresholds, ensuring your cleaning validation protocols are both safe and compliant.

SAXOCON provides the technical foundation for your cleaning validation strategy, including:

• Comprehensive Data Review: A detailed assessment of all available non-clinical and clinical data to inform safety limits.
• Predictive Modelling: Utilizing (Q)SAR and other in-silico models to fill critical data gaps for legacy or poorly characterized substances.
• PDE Derivation: Establishing Permitted Daily Exposure (PDE) limits strictly following EMA/CHMP/CVMP/SWP/169430/2012 guidelines for shared manufacturing facilities.
• Hazard Identification: Pinpointing major toxicological risks, such as sensitizing agents or substances with genotoxic potential.
• Mutagenic Impurity Control: Managing mutagenic risks using the principles and methodologies described in ICH M7.

Why Choose SAXOCON?

Our cleaning validation services provide the scientific defensibility required for high-stakes manufacturing audits:

• Computational Toxicology Leadership: Best-in-class experience using chemical structure modelling to predict biological effects and justify safety margins.
• Multidisciplinary Team: Direct access to toxicologists who specialize in the complex interactions of pharmaceutical cross-contamination.
• Regulatory Authority: Extensive experience delivering safety assessments that satisfy the most stringent international standards and GMP requirements.
• Operational Efficiency: Smart, cost-effective strategies that establish realistic, scientifically sound limits, preventing unnecessary production downtime.

Delivery

SAXOCON compiles all findings into a formal PDE Determination Strategy Report. This document provides the essential toxicological evidence required to fulfill GMP requirements and serves as the cornerstone of your site’s cleaning validation master plan.