Insights
Changes Are Coming: Annex 1 Manufacturing of Sterile Products and Staying Ahead of the Curve
INTERPHEX Live presents Aaron Weinstein and Russ Somma. In recent years, the EU has been planning to update Annex 1 and, based on the drafts that have circulated, their intent is to create regulations and guidance that provide more detail. As part of this INTERPHEX Live discussion, we will talk about why the Annex will be updated and what information will be added to the Annex.
Related Experts
Related Projects
View All ProjectsRelated Expertise
Related Happenings At IPS
-
Insights
Annex 1 (2022) – The Brave New World of Regulatory Compliance
After six years in draft form and through various consultations with Industry, the revision to Annex 1 was finally released in August 2022 and will become effective in August 2023. It is the greatest single change to the regulator -
Event - Speaking
cGMP Annex 1 Workshop
May 09, 2023 | Barcelona,
The cGMP Annex 1 Workshop will feature industry experts who will provide practical solutions for implementation of the new guidelines at your organisation. These experts were intensely working on commenting and developing solution