- This topic has 2 replies, 2 voices, and was last updated 6 years, 2 months ago by .
Ancillary Supply Management Requirements
Are there any regulations/guidance documents on minimum requirements for ancillary supplies provided for use in Clinical Trials? Specifically related to temperature monitoring of storage. FDA doesn’t address Ancillary supplies. The EU CTR now defines AxMP, but storage monitoring is not specified.
The problem I run into is that in the event of excursions the manufacture typically cannot provide any stability information outside of the label.
Thanks in advance!
You must be logged in to reply to this topic.