Although single-use systems (SUS) are well established in the biopharmaceutical industry, there is limited guidance on regulatory expectations. The challenge when moving from stainless steel equipment to SUS is the shift of responsibilities for quality control of the manufacturing equipment from the end-user to their supplier. In final filtration and filling operations, sterility assurance, particles risk, as well as the interaction of the plastic components and the process fluid, are closely reviewed during submissions and inspections. We will focus on key considerations of SUS implementation in the light of expectations addressed in the upcoming European GMP Annex 1 on Manufacture of Sterile Products.
In this webinar, you will learn about:
- Regulatory expectations when implementing and using single-use systems
- Quality control of single-use systems – a shift of responsibility from end-user to supplier
- How single-use systems enable closed processing
Speaker
Simone Biel, Ph.D.
Merck
Senior Regulatory Consultant
Simone Biel provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on single-use technology. Over the years, Simone has supported biopharmaceutical drug manufacturers’ implementation of single-use technology in their manufacturing process. With her deep understanding of single-use technology market needs and industry trends, she is the subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in microbiology.
Pharma and biopharma manufacturing
- Downstream Processing
期间:1h 5min
语言:English
场次 1:往期 July 12, 2022
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