Packaging and Labeling frozen IP

This topic has 1 reply, 2 voices, and was last updated 1 year, 5 months ago by Anonymous.

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June 30, 2022

Packaging and Labeling frozen IP

In preparation for labeling -70C cryovialed IP, the operation will require a thaw time to bring the vial to a temperature to adhere the label. What studies would be required to justify product integrity during the time out of storage environment for labeling and packaging?

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