The Annex 1 checklist is a helpful tool for life science manufacturers to ensure that their sterile manufacturing facilities are compliant with the latest regulations. With the new Annex 1 guidelines set to take effect in August 2023, it is more important than ever to ensure that your facility is up to date and in compliance.
Not only does mold pose a risk to patient safety, but it can also result in product recalls, financial and reputational damage, and regulatory consequences. However, by using the right preventative cleaning and disinfecting products and procedures, manufacturers can significantly reduce the risk of mold contamination in sterile environments.
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In this episode of Exceeding Your Benchmark, Ashley Harp, Lead Process Engineer at CRB, talks about the challenges of pharmaceutical manufacturing adapting to rapid innovation of new therapies and various options to meet demand.
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In this episode of Exceeding Your Benchmark, Sumit Verma, Senior Vice President Global Strategic Manufacturing at Iovance Biotherapeutics, talks about the challenges faced by new biopharma startups and how cell and gene manufacturers can scale to meet demand.
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Podcast Host Gabrielle Bejarano talked to Chris White, who is the Global Head of GMP at Adamas Consulting, about what’s new and different in Annex 1, and how sterile manufacturing companies and facilities can meet the regulations by the summer of 2023.
In pharmaceutical manufacturing, the presence of endotoxin poses a risk to final product quality and patient safety. This article will discuss what endotoxins are, how they can be detected, and how you can prevent contamination.
Jump to video discussion On August 25th 2022, the FDA alongside EMA jointly released its new Annex 1 regulations for sterile drug manufacturing processes, monitoring, quality control, and more. The revision has been 14 years in
