The acceptance of Particulate Contamination cannot be achieved by a well-formulated risk assessment. The patient and the pharmaceutical industry's desire to produce the best product quality are key paramount.
Particulate Contamination therefore play an important role in the production of raw materials, active ingredients and ultimately finished products.
The practice of GMP consultancy shows: Repeatedly, particulate contamination leads to observations in the reports of national and international regulatory authorities. Also, inadequate investigations, insufficient preventive actions, and inadequate root cause analyses contribute to reactions from the supervisory authorities.
Specific regulatory requirements regarding Particulate Contamination (besides for parenterals) are not in place. Well-elaborated guidelines from APIC (Guidance on Insoluble Matter and Foreign Particles in APIs) and IPEC (Guide on Technically Unavoidable Particle Profile (TUPP)) present best practice documents that aim to provide a widely applicable procedure for the control of foreign particles.
The live online training "Handling of Foreign Particles in APIs and Excipients" is dedicated to this topic. It is offered by the ECA Academy as part of the GMP Certification Program and will take place on February 5 and 6, 2025. Managers, Process and Quality Assurance/Quality Control employees in active ingredient and excipient production will learn essential aspects of the control of foreign particles in APIs and excipients.
Dr. Martin Melzer, Principal Consultant at gempex, will speak at this live online seminar of the European Compliance Academy. With a background of experience in industry, authorities and GMP consultancy, these aspects will be discussed - with practical examples.
Participants gain in-depth knowledge about recognizing the occurrence of particulate impurities, systematics for searching for the causes and the importance of particulate impurities in medicinal products. It will be presented how Good Practices to minimize the presence of Particulate Contamination can look like.
Furthermore, an overview is given on the influence of cleaning procedures and the use of specific analytical methods to control foreign particles.
Detailed information and a registration form are available in the detailed program of the event at the ECA Academy.
Dr. Martin Melzer will be happy to answer any questions on the subject of "Control of foreign particles in pharmaceutical production" via contact@gempex.com.