Drug substance storage condition

Quality Assurance
1

Dear All

I am from R&D. The query is regarding one of the API that was introduced into manufacturing.
The API is a very stable molecule at ambient conditions. However one of its physical attribute (particle size) agglomerated at ambient condition and therefore based on customer requirements it was decided to store at 2-8 deg C.
Two years completed and no issue with any of the attribute in shelf-life.
API is also filed and approved.
Now BD team identified new customers and storage condition is discussed. The chemical attribute and other physical attributes of this API are very stable at ambient condition.
**The question is, BD team wants ambient storage and R&D says that 2-8 deg C was designed for customer specific requirement and no issue with ambient storage. Can QA allow BD team to declare customer for ambient storage **

2

Yes, based on stability studies at ambient condition for those particular physical attributes QA can consider this proposal of BD.

However, that particular customer should be informed about those physical attributes which are only stable at 2 - 8 deg C and not in ambient condition.