They exist, the "Technically Unavoidable Particles" (TUP). In starting materials and APIs/active ingredients, they represent an impurity that can later also be found in the drug itself. This can result in a risk to patients. How should TUPs be handled if they cannot be avoided technically, or if the technical effort to avoid the impurities or to remove foreign particles later on is so high that it simply cannot be afforded?
ECA will host a live online training session on "Dealing with Foreign Particles in APIs and Active Pharmaceutical Ingredients" on January 25 and 26, 2022. Dr. Martin Melzer, Principal Consultant and GMP expert at gempex, has been called in as a qualified person and will present two highlight topics of the event at once: "Strategies for finding the source of particulate impurities" and "Particulate impurities in medicinal products".
Further emphasis of the online training will be placed on topics such as preventive measures to minimize foreign particles, acceptance criteria for particles in APIs and analytical control methods.
Overall, existing philosophies and technical standards for dealing with technically unavoidable particles are presented, with a clear focus on identifying the source of contamination and dealing with any contaminations that do occur.
The importance of this topic is largely attributable to patient safety. However, the economic efficiency of the companies also plays a role. The warning letters published on the Internet by the U.S. FDA for various active ingredient manufacturers suggest that particulate contamination is being dealt with rather laxly time and again. And once the feared warning letter has been received, the pressure increases enormously to submit a catalog of measures within 15 days to eliminate the deficiencies noted.
However, if sufficient know-how is available, even technically unavoidable particles can be handled confidently and in a patient-safe manner.
Do you have questions about dealing with TUPs or are you facing an FDA audit? Dr. Martin Melzer is looking forward to your contact via info@gempex.com.
The detailed program of the upcoming event as well as information on registration can be found here.