(Total Views: 594)
Posted On: 05/19/2020 7:27:00 AM
Post# of 145890
The shelf life should continue to be extended.
The stability studies that were initially being done should be ongoing - at periodic intervals, another set of vials should be taken out of the stability chamber and tested to make sure the drug is still viable in the container with the container closure system.
With good results, longer shelf life could granted and the new longer shelf life could then be place on the product packaging.
This is important from a supply chain perspective because many companies require a minimum remaining shelf life in order for them to buy the product.
IMO
The stability studies that were initially being done should be ongoing - at periodic intervals, another set of vials should be taken out of the stability chamber and tested to make sure the drug is still viable in the container with the container closure system.
With good results, longer shelf life could granted and the new longer shelf life could then be place on the product packaging.
This is important from a supply chain perspective because many companies require a minimum remaining shelf life in order for them to buy the product.
IMO
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