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.
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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 -
Insights
From Regulators to PUPSIT: Notes on Annex 1 Revision Implementation
The European Union’s Good Manufacturing Practice (GMP) Annex 1 Revision is set to take effect on August 25, 2023. Annex 1 will offer a broad-reaching regulatory revamp that will impact any pharmaceuticals manufactured for export -
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Three Steps All Companies Should Take to Reach Annex 1 Compliance
The clock is ticking. In August 2023, the EU GMP Annex 1 Revision will take effect. Facilities that do not comply with the new standards risk shutting down their manufacturing lines or losing market share in the EU. While