CPHI Webinar Series

GMP Rationale for Sterile High-Potency/Toxic Pharmaceuticals

18th June, 2024
4pm CET / 10am EST
What will this webinar address?

In the 1960s, concerns over the quality of pharmaceuticals led to the introduction and mandatory implementation of Good Manufacturing Practice (GMP). Since its inception, GMP has operated on two fundamental principles: the "requirements" detailing what should be done and the "purpose" describing the desired outcomes. These principles are particularly relevant in the manufacturing of cytotoxic and high-potency

Such products present significant challenges due to their potential to affect operators and the environment even in minute doses, thereby increasing the risk of cross-contamination. The complexity is further compounded when these products are manufactured as sterile pharmaceutical forms, necessitating stringent adherence to GMP guidelines which emphasize the interconnectedness of requirements and purpose in ensuring safety and efficacy.

    Wanting to know more? Then join the latest CPHI Webinar, brought to you by Prasfarma as we delve the latest developments in GMP and HPAPI’s

    • Assessing the risks and challenges in cytotoxic and Highly-potency products in sterile production
    • Reviewing manufacturing requirement of cytotoxic and high-potency products case-by-case analysis using Quality Risk Management (QRM) to assess risks and determine necessary controls.
    • Why sterile medicines remain a challenge in pharmaceutical production and how GMP outlines detailed requirements and demands personalized analysis to ensure a robust Contamination Control Strategy (CCS).

Dr. Jordi Botet
GMP Consultant

Dr. Jordi Botet is a graduate in Biology and in Pharmacy. He is Ph.D. in Pharmacy. Presently, he works as a consultant providing world-wide GMP guidance and training. He has been involved in pharmaceutical manufacturing and in public health laboratories in Europe, Russia and South America. Since 1997 he has been cooperating in pharmaceutical projects, providing advice and training on GMP-related topics (quality risk management, pharmaceutical quality systems, quality audits, qualification and validation, clean rooms, process performance and product quality monitoring, documentation systems, etc.). Dr. J. Botet has written more than thirty papers both on microbiology and parasitology and on different pharmaceutical topics (utilities, premises, quality assurance, change control, risk management, validation, training, etc.). Dr. J. Botet has published several books on GMP, pharmaceutical projects and quality systems. He can use several languages and this has allowed him to give many lectures and courses in different countries of Europe, America, Africa and Asia.

This webinar is brought to you by

GMP Rationale for Sterile High-Potency/Toxic Pharmaceuticals
  • 18th June, 2024
  • 4pm CET / 10am EST
  • 60 minutes
  • Free
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