A facility has stability data for a CSP they typically package in PVC bags but are now going to prepare it in syringes as the final container. Which of the following is true?A. they can still use their stability data from the PVC bagsB. they must either repeat stability testing and container closure studies in their new container or find peer reviewed study that matches their new process and containerC. they can assign the BUD they assign to PVC bags as long as they repeat sterility testing on their initial batchD. they can assign the BUD they assign to the PVC bags as long as it is the same volume and is prepared using the same NDC starting ingredients
A facility has stability data for a CSP they typically package in PVC bags but are now…
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