What Does Annex 1 Mean For Cryovial Filling?

The revised EU GMP Annex 1 is setting a higher standard for sterile manufacturing, a challenge felt keenly in the cell and gene therapy (CGT) space due to the high-value and sensitive nature of their products. A critical area often falling short of the new requirements is the manual filling of cryovials, an activity where quality and sterility lapses may not be discovered until months after thawing, resulting in significant time and financial losses.

To meet these enhanced aseptic expectations, manufacturers must prioritize minimizing contamination risk. This means consistently maintaining Grade A "first-air" protection over open vials, drastically reducing operator interaction through automation, minimizing the total open vial exposure time, and implementing robust in-process controls like a 100% IPC dose weight check. Understanding these four key principles is essential for protecting product integrity and ensuring patient safety under the new Annex 1 framework. Discover how to effectively align your cryovial filling process with the latest regulatory mandates.