Hi Anon.
I would caution you to look closely at the regulations and to remember that the definition of a "drug product"
includes excipients used in manufacturing drug products. So if you are marketing your product as a drug excipient, than 21 CFR requirements could be read to apply to your products as well.
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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 05-Sep-2018 12:19
From: Anonymous Member
Subject: Warehouse temperature/humidity mapping for excipient manufacturer
This message was posted by a user wishing to remain anonymous
I'm curious if there is any regulatory requirement (in particular from FDA) for an excipient manufacturer to do temperature/humidity mapping of their warehouse? Or is it sufficient for the excipient manufacturer to merely have temperature/humidity monitors in the warehouse? [The regulations in 21 CFR 110, 111 and 211 seem to apply to only manufacturers of finished foods, finished dietary supplements and finished drug products -- so is there something similar for manufacturers of excipients?]
Thank you for any insights about this!