They exist, the "Technically Unavoidable Particles" (TUP). They represent an impurity in excipients and API, as they are later also found in the drug. This may result in a hazard to the patient. Sometimes, however, foreign particles cannot be technically avoided. Or the technical effort to avoid the impurities or to remove foreign particles in later steps is simply too high. So what is the best way to deal with TUPs?
ECA Academy will hold a live online training on "Handling of Foreign Particles in APIs and Excipients" on January 26 and 27, 2021. Dr. Martin Melzer, Principal Consultant and GMP expert at gempex, will be a speaker and will present two highlight topics of the event with „Incident management – how to identify the source of insoluble matter“ and with „Foreign Particles in Excipients and Finished Product Quality and Safety“.
Other topics covered in the online training include preventive measures for minimizing foreign particles, acceptance criteria for particles in APIs, and analytical control methods.
Overall, this seminar will present the existing philosophies and technical standards for dealing with Technically Unavoidable Particles. Focus will be on identifying the source of contamination and how to deal with any contamination that occurs.
But why is this topic so important? First and foremost, there is certainly patient safety. But the profitability of the companies also matters. The warning letters published on the Internet by the US FDA for various active ingredient manufacturers suggest that particulate contamination has repeatedly been dealt with all too carelessly. And once the dreaded Warning Letter has been received, the pressure increases enormously to submit a catalog of measures within 15 days to eliminate the identified deficiencies.
With sufficient know-how, however, even technically unavoidable particles can be dealt with confidently and safely for patients.
Do you have any questions about dealing with TUPs, or are you facing an FDA audit and you would like to be on the safe side? Dr Martin Melzer is looking forward to your contact via info@gempex.com.