Handling of Foreign Particles in APIs and Excipients

-    Live Online Training with GMP expertise from gempex on March 01 /02, 2023
-    ECA Academy GMP Certification Programme

In the pharmaceutical industry, visible particles play an important role in active ingredients or starting materials such as pharmaceutical excipients. Detecting them and determining their point of origin is of enormous interest. Repeatedly, their presence leads to observations in the inspection reports of national and international regulatory authorities. Also, both the methods of investigation, the corrective measures to get processes and equipment under control, and the preventive measures to prevent future occurrence have been the bone of contention time and again.

There are very few guidance documents dealing with this topic. Mentioned here should be the APIC Guidance on Insoluble Matter and Foreign Particles in APIs and the IPEC Guide on "Technically Unavoidable Particle Profile (TUPP)" - both best practice documents that attempt to present a widely applicable procedure for the control of foreign particles.  

The Live Online Training "Handling of Foreign Particles in APIs and Excipients" on March 01 and 02, 2023, offered by the ECA Academy as part of the GMP Certification Programme, is dedicated to precisely this topic. It provides comprehensive information to managers, process and QA/QC staff in API and excipient production. All relevant aspects of the control of foreign particles in APIs and excipients will be discussed.

Dr. Martin Melzer, Principal Consultant at gempex, is one of the lecturers at the training. The event will cover the basics of why this topic is of such great interest, through blocks of topics such as how to deal with technically unavoidable particles, the identification of their origin, and the rationales to be defined and proven with regard to acceptance criteria. Particular emphasis is placed on recognizing the occurrence of particulate contamination in the course of a manufacturing process, systematics for troubleshooting, and the significance of particulate contamination in the drug which will incorporated into the patient when applied. The focus is not only on sterile drugs - it concerns all dosage forms. And new on the horizon: Contamination with nanoparticles, which have not received any recognition under pharmaceutical law yet.

Practical and illustrated case studies show the practice. It is presented how, for example, cleaning procedures can be used to minimize the occurrence of such particles. The associated investigative analytical methods are addressed. Risk management methods play a role and are discussed.

And there is one conclusion: When particulate contamination occurs, action must be taken. Acceptance cannot be achieved even by a well-designed risk assessment. Because the patient is always in the foreground and the striving of the pharmaceutical industry to produce the best possible quality and to make it available to the patient.

Further information as well as an application possibility are provided in the detailed program of the event.

The gempex expert team will be happy to answer any questions on the topic of "Control of foreign particles in pharmaceutical manufacturing" via contact@gempex.com.