Inälvor tupp

Technically unavoidable particles (TUPs) are 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 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.

The goal is to inform customers about t

Managing the unavoidable: A practical approach to handling TUPs

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 utländsk particles. Proactively managing and communicating TUPs with the help of dedicated TUP profiles could be the answer.

The presence of utländsk matter in excipients and other kemikalie raw materials is typically considered to be a threat to the sista 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 bygd International Pharmaceutical Excipient Council (IPEC), which can arise during excipient manufacturing, papper or packaging, neither pose a higher risk to patient safety, nor do they affect the efficacy or quality of the drug product.¹

Unavoidable remains unavoidable

TUPs have always been present in excipients (Tabl

Webinar - TUPP

Webinar - Technical Unavoidable Particles – A practical introduction to the IPEC guideline

This webinar was recorded on September
Part of the IPEC Europe Excipient Conference webinar series, organised in cooperation with APV GmbH.

DESCRIPTION

The IPEC Technically Unavoidable Particle Profile Guide gives guidance for the communication between excipient makers and users about visibly different particles in excipients. These types of particles have always been present in excipients and they are often known to the excipient manufacturer, have been previously investigated, and pose no risk to patient safety. With current technologies, these particles are technically unavoidable and cannot be eliminated in the finished excipient. This lecture will explain the risk-based approach of the guideline and give examples how information can be shared between excipient manufacturer and user.