RAC Practice Exam – Complete Guide for Regulatory Affairs Certification

Question: 1 / 400

What is NOT required by the FDA to support product postapproval stability requirements?

A Three batches per year per container closure

The correct response highlights that the FDA does not mandate the submission of three batches per year for each container closure as part of the postapproval stability requirements. Instead, the focus is on ensuring that there is an adequate number of batches that can provide meaningful data to support stability claims. Additionally, the FDA emphasizes having reliable, meaningful, and specific test methods for assessing stability, as well as a commitment to maintain compliance with postapproval stability testing commitments. This approach allows for flexibility in how manufacturers collect stability data, focusing more on the quality and sufficiency of the information rather than strictly on the number of batches produced within a specific timeframe.

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B An adequate number of batches

C An amount that is compliant with the postapproval stability commitments

D Reliable, meaningful, and specific test methods

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