Motivated by the need to reflect changes in both the regulatory and manufacturing environments, the long-awaited revised Annex 1 on the Manufacture of Sterile Medicinal Products was published by the European Commission on August 25th, 2022. The new revision clarifies that the intent of Annex 1 is to provide guidance for the manufacture of sterile products in general, comprised of sections on active substance, excipient, primary packaging material and finished dosage form.
Some of the principles included in the Annex 1 guidance may be applied to other non-sterile products where filtration is utilized for bioburden reduction without a sterility claim.
Given the potential variability in filtration performance for these non-sterile products, the overall Contamination Control Strategy (CCS) becomes even more important for regulators to assess the overall bioburden control during manufacturing. As a result, it is critical to have a detailed knowledge of the process and all potential sources of contamination, which is needed for development of a comprehensive CCS as described in Annex 1.
Join our panel discussion on January 18, 2023, where experts on regulation, filtration, sampling and quality control will share insights on how to overcome these challenges and ensure a successful bioburden reduction and testing, in compliance with the new EU GMP Annex 1 regulation coming into operation on August 25th, 2023.
In this webinar, you will learn:
Global Product Manager–Filtration & Rapid Detection Platforms
Adrien has gained more than 10 years of experience at our company in developing highly innovative life science products for the pharmaceutical industry and collaborating with the global scientific community. Adrien has worked in different positions across R&D, validation and marketing.
Director of Strategic Marketing Pharma
Marilyn Romieux (Vicente) is the Strategic Marketing Director for Pharma microbiology QC for MilliporeSigma. She started as an R&D Scientist in the field of rapid microbiology before moving to a marketing role where she created a new range of application services designed to support users in developing and implementing microbiology QC methods. Her recent background as Head of Technical Marketing also includes employee education, customer training, and application development. With an extensive knowledge of microbiology QC and nearly two decades in serving the pharma industry, she recently took the role of Strategic Marketing Director, where one of her assignments is leading the marketing of MilliporeSigma's Robotics & Automation offer. She graduated in Cell Biology and Biochemistry from the University of Strasbourg, France, and earned her Master’s degree in Life Sciences from AgroParisTech in Paris, France.
Global Product Manager Sampling
Marc-Antoine Kaag is Senior Product Manager for Sampling strategy at Merck KGaA, Darmstadt Germany. He brings over 15 years of experience in the Life Science industry. Marc-Antoine has held various roles from Product Validation, Engineering to lifecycle Product management. His most recent mission is on the development & execution of a new strategy for the Sampling portfolio, in order to support Biopharma industry evolution over times. He received a Bachelor of Science Degree in Biology & Food safety from Paris VI and a Master in Quality & Business organization from the University of Strasbourg.
Lead Application Services, Biomonitoring
Stéphanie Huck is in charge of Application Services within the BioMonitoring marketing department of Merck, KGaA, Darmstadt, Germany in Molsheim, France. She joined the company in 1997. Stéphanie holds a degree in Biology of Microorganisms from the University of Strasbourg, France.
Simone Biel, Ph.D.
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.
Somasundaram G (Som)
Som is a consultant with customers for regulatory compliance, closed processing, and other areas in biopharmaceutical applications. He is also a member of PDA and ISPE industry associations. Som has worked in different functions within MilliporeSigma for the last 19 years, including heading technology management, tech service, BioReliance® filter validation lab, commercial role, and business development areas. He also worked for a year in QA/QC as well as obtained one year of academic experience in microbiology.
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