In the wake of revised Annex 1 regulations, BenchmarkGMP Cleanroom Socks address the highlighted need for dedicated footwear in Grade B and C cleanrooms. These socks combine compliance with comfort, becoming an essential tool for facilities prioritizing quality and safety.
In this episode of Exceeding Your Benchmark podcast, our host Michelle Dawn Mooney dives into an engaging conversation with Fred Ayers, Advisor for Sterility Assurance for Global Quality Systems at Eli Lilly. Fred imparts valuable insights on the dynamic field of contamination control in pharmaceutical manufacturing.
Sheba Zaman of Novatek International is featured on the podcast to discuss how technology can provide visibility and powerful decision making for contamination control in pharmaceutical manufacturing. She explains the difficulties in the industry of digitalizing due to regulations, product safety and taking liability into account. Additionally, she discusses how utilizing data lakes and connecting elements of contamination control can provide insight and trend analysis.
Benchmark Products is excited to announce that we will be exhibiting at Interphex 2023 in New York City from April 25-27. We invite you to join us at Booth #2020 to discover our latest technologies and services that can help you become compliant with the new Annex 1 regulations.
To achieve the new Annex 1 requirements, life science manufacturers need cleaning and disinfecting solutions that are backed by science and offer reliable, consistent results. In this article, we’ll explore how Suite Ultra-Fiber cleaning and disinfecting solutions can help maintain a sterile manufacturing environment.
Get Ready for Annex 1: The Importance of Compliance and How the Annex 1 Checklist Can Help You Get There
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.
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.
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 the making, and largely overhauls the original 2008 good manufacturing practices with the aim of reflecting the changes of evolving manufacturing processes. The new regulations take effect on August…
After several years of delays, the EU and FDA are now doubling down on their efforts to force drug manufacturers to comply with Annex 1…