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Strategy for Pharmaceutical Submission
Background
A major manufacturer of IV pharmaceuticals was facing leakage problems with the IV bag. Their quality and engineering teams identified a solution that would eliminate the leaks by making a change to the resins in the bag. They were unclear on the submission strategy since the guidance documents were unclear. The company originally defaulted to a time-intensive Prior Approval Supplement (PAS) instead of a CBE 30.
RCA saved about 1 ½ years from the schedule, maintaining revenues and increasing product quality.
Solution
The Regulatory Compliance Associates® Inc. consultant examined the corrective action, noting that the strengthening of the IV bag came from changing the ratio of the resins but not the actual resins. Because no new resins were being introduced to the pharmaceutical, RCA suggested a CBE 30 instead of the PAS.
CBE 30 Result
After reviewing the RCA strategy with the FDA, the company submitted and was able to address product complaints and maintain product revenues.
