The simple answer to your question is yes, yes, and does include your last question.
Unless you have specifically designated, specified, verified, and/or validated different storage conditions for shipping and transport, most regulatory authorities, without it being specifically stated, would take the "storage" conditions from finished goods, warehousing, shipping, transportation, and distribution, even at the customer site. If your device could have different shipping and transport conditions, these need to be specified and validated.
By default Storage does mean warehouse or storage locations - where the product is just sitting there. However, cGMP is in effect so there are now many interpretations that Storage applies to a much wider range depending on the product. And if you are compliant or certified to ISO 13485:2016, storage has a significant range of what "storage" means including the standard including now constituent parts.
As noted storage, handling, and distribution nowadays encompasses a large area including finished packaging areas, hold areas, awaiting QC test areas, quarantine areas, etc. The storage conditions must start applying to the device once it is "final" so if sitting there in packaging waiting to be packaged or sitting in a "hold" location waiting for QC/QA release, storage conditions apply. I was involved in an audit some time ago that received an observation because we were not monitoring our finished goods packaging area because the product had a narrow (not small) temperature storage range. The product could be sitting there in a production area for a day or more, yet we were not monitoring that area for temperature excursions (which unfortunately did occur).
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 18-Sep-2018 16:46
From: Patrick Kager
Subject: Definition of "Storage" conditions on labeling
CFR 820 covers storage, handling and distribution. However, the temperature requirement for storage and distribution need not be the same. As part of the stability and ship test protocols, you can specify different conditions. This would depend on the specifics of the device. For sterile devices, I'd suggest looking at ISO 11607.
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Patrick Kager
MedPharma Partners LLC
United States
Original Message:
Sent: 17-Sep-2018 19:51
From: Anonymous Member
Subject: Definition of "Storage" conditions on labeling
This message was posted by a user wishing to remain anonymous
Hello team members,
I have a question, hope someone could provide any comments or guidance about a this (considering our Finished Device is a Medical Device):
- If a finished product label includes statements about storage conditions within a temperature range, is that meant to include the "temperature during shipping/transportaiton" as well?
- According to FDA's criteria, "Storage" means solely the activities and specifications related to the Warehouses, like Distribution Centers?
- whats about the "Final Packaging Areas" and the "Quarantine areas" at the manufacturing sites? Thank you in advance.