Managing the unavoidable A practical guide to handling technically unavoidable particles(TUPs)

摘要

Although they don't actually pose a risk to patient safety,they can nonetheless create problems:they are technically unavoidable particles(TUPs),which can be found in chemical raw materials such as excipients.If not identified as being innocuous,they can lead to entire raw material batches being rejected-unnecessarily and often at high costs-by users.Still,there are no official guidelines available regarding how to deal with these foreign particles.Proactively managing and communicating TUPs with the help of dedicated TUP profiles could be the answer.The presence of foreign matter in excipients and other chemical raw materials is typically considered to be a threat to the final pharmaceutical product's quality.In fact,particles can endanger patient safety.They can also violate compendia and regulatory requirements,disrupt supply chains,lead to drug shortages and harm a company's reputation.However,not all particles are dangerous.Technically unavoidable particles(TUPs),as defined by the International Pharmaceutical Excipient Council(IPEC),which can arise during excipient manufacturing,handling or packaging,neither pose a higher risk to patient safety,nor do they affect the efficacy or quality of the drug product.