Annex 1 sterilisation: Why pharma packaging strategy is changing - Pharmaceutical Technology

Double sterilisation is transforming sterile pharmaceutical packaging, from RTU elastomers to steam and gamma validation. Double sterilisation is transforming sterile pharmaceutical packaging, from RTU elastomers to steam and gamma validation. The revised EU GMP Annex 1 has ushered in a new phase for sterile manufacturing. Published in 2022, with most provisions taking effect in August 2023 and full applicability following in August 2024, the guidance has sharpened expectations for contamination control, process understanding and validated sterile manufacturing pathways. You will receive an email shortly. Please check your inbox to download the Whitepaper. By downloading this Whitepaper, you acknowledge that GlobalData…

Source: Pharmaceutical Technology