Technically Unavoidable Particles (TUPs) are always present in excipients. Concern regarding their presence has increased dramatically in recent years due to several US FDA warning letters to pharmaceutical companies, highlighting adverse findings during inspections.
SAXOCON can help pharmaceutical manufacturers develop their Technically Unavoidable Particle Profile (TUPP). These profiles help to proactively search for foreign particles and provide suppliers with the necessary information to support proper risk mitigation. TUPPs are a proven method of open communication with raw material suppliers that helps both excipient and pharmaceutical manufacturers ensure product safety.
Because TUPs are always present, they must be accounted for at all stages of production, from pre-production material sourcing to production equipment wear to packaging and storage. Typically, the presence of foreign matter in excipients and other chemical raw materials is seen as a threat to final pharmaceutical product quality. Such particles can present a real danger to patient safety and violate regulatory requirements, disrupt supply chains, lead to drug shortages, and cause reputational damage to the manufacturer. However, not all such particles are dangerous, according to the International Pharmaceutical Excipient Council (IPEC). Therefore, pharmaceutical manufacturers need to ensure that the TUPs in their products do not impact patient safety and avoid the worst-case scenario of an entire batch recall.
Find out more about how we can help you ensure product safety here.