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Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex, discusses changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.
For aseptically produced products, contamination control is critical. As a result, various associations and regulatory bodies have published guidance documents on the many safeguards required to ensure compliance with requirements. Most recently, industry has been awaiting the revised Annex 1 guidance from the European Union, which is currently still under consideration in draft form. Additionally, there is an increasing proportion of products in development that cannot be terminally sterilized, meaning there is a rising need for efficient aseptic processing solutions. In a keynote session titled “Evolution of Aseptic Processing”, presented at INTERPHEX 2021 on Oct. 20, 2021, several experts discussed the evolution of aseptic processing and provided insights into some of the challenges and opportunities facing the bio/pharma industry today.
The session was moderated by Felicity Thomas, European editor, Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International. In this video, Felicity interviewed Patrick Nieuwenhuizen, Senior Manager/Consultant, PharmaLex. Patrick spoke about the changes to regulatory requirements, quality risk management, audits, and operational considerations of aseptic processing.
This video is part 1 of 5. The other speakers in this session were:
Watch other videos in this keynote series: