Delve into Annex 1's impact with our latest Ansell Clean Talk podcast🎙️ In this episode, we'll be talking about the new EU GMP Annex 1, which sets out guidelines for the manufacture of sterile medicinal products.
Don't miss out on this insightful conversation between two experts in the field, Ann Van Dee Borre (Senior technical services and training manager at Ansell) and Tim Pressler (Associate director of sales at Ansell) - listen and learn today!
Contents of the podcast ▬▬▬▬▬▬▬▬▬▬
00:00 - Intro to Ansell Clean Talk
02:24 - What is EU GMP Annex 1?
06:10 - What is the role of Quality Risk Management (QRM) & Contamination Control Strategy (CCS) in helping to ensure the safety of products during production?
08:35 - What is the importance of using barrier technologies?
09:20 - What is the difference between RABS & isolator gloves?
12:50 - What are some of the key points specified in Annex 1 regarding ‘personnel’?
15:58 - What are the guidelines outlined in Annex 1 regarding sterilisation and packaging?
Check out our in-detail article on the EU GMP Annex 1 Guidelines and learn how Ansell’s innovative products can revolutionise your cleanroom operations 👉 [ Ссылка ]
Download our whitepaper for comprehensive guidance on Annex 1 compliance 👉 [ Ссылка ]
Explore Ansell's Life Sciences products and safeguard your cleanroom environment, visit 👉 [ Ссылка ]
