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A facility has stability data for a CSP they typically package in PVC bags but are now…

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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 bags B. 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 container C. they can assign the BUD they assign to PVC bags as long as they regeat sterility testing on their intial batch D they can assign the BUD they ansign to the IV C hap as love as it is the same valume and is prepared using the same NDC starting ingredients

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