Manage Raw Material Risks and Ensure Compliance

Technically Unavoidable Particles (TUP) are inherent to many raw materials used in pharmaceutical manufacturing. Good Manufacturing Practice (GMP) requires that the impact of these particles on product safety be thoroughly evaluated to maintain quality standards. SAXOCON utilizes the framework defined in ICH Q9 and the 2024 IPEC Technically Unavoidable Particle Profile (TUPP) Guide to provide a scientifically robust assessment of these impurities.

A predefined Service Level Agreement (SLA) with SAXOCON ensures a fast-track process to evaluate TUP impact without disrupting your supply chain:

• Accelerated Assessment: Optimally stacked activities ensure a 2–3 week turnaround from discovery to a finalized toxicological risk assessment.
• Root-Cause Identification: Specialized laboratory capabilities to quickly identify the source, composition, and nature of particles.
• Proactive Risk Mitigation: Expert advice on sampling strategies and process adjustments to manage TUP levels.
• Toxicological Evaluation: Comprehensive risk assessments to determine the safety profile of particles in the context of the finished drug product.

Why Choose SAXOCON?

Our TUP services allow you to navigate raw material impurities with technical certainty:

• Adoption of Latest Standards: Early adopters of the 2024 IPEC TUPP Guide, ensuring your safety profiles meet the most current industry expectations.
• Multidisciplinary Precision: A team of toxicologists and scientists who understand how TUPs interact with drug formulations.
• Operational Speed: A structured response system designed to provide answers quickly, preventing long-term production bottlenecks.

Delivery

SAXOCON compiles all analytical and toxicological findings into a formal Toxicological Risk Statement. This document provides the defensible evidence required for your quality management system, confirming that technically unavoidable particles do not compromise patient safety or product integrity.