Regulatory Affairs Certification (RAC) Practice Exam

Which of the following does NOT describe requirements for reserve samples?

1. A reserve sample representative of one lot of shipped product per year must be retained.

2. The reserve sample should be at least twice the amount required for all tests required to determine whether the active ingredient meets established specifications.

3. Reserve samples should be stored under conditions equivalent to the product storage conditions.

4. Any evidence of reserve sample deterioration should be reported.

The correct answer is: The reserve sample should be at least twice the amount required for all tests required to determine whether the active ingredient meets established specifications.

The assertion that a reserve sample should be at least twice the amount required for all tests to determine whether the active ingredient meets established specifications does not accurately reflect typical requirements for reserve samples. In regulatory practices, reserve samples are intended to ensure that a sufficient quantity is available for future testing, but the specification of "at least twice the amount" is not a standardized requirement. Rather, the key objective of maintaining reserve samples is to have an adequate amount for potential testing if issues arise or if the product needs to be retested as part of quality assurance practices. It is critical that the amount retained is sufficient to cover the necessary tests, but not necessarily defined as double that amount. The focus is on practicality and ensuring that the sample can fulfill the intended purpose without excess. In contrast, the other options illustrate more widely accepted practices: retaining representative samples of shipped product lots, ensuring the storage conditions of the reserves mimic those of the products to maintain their integrity, and mandating that any deterioration of reserve samples must be documented and reported. These reflect the standard practices in regulatory frameworks to ensure product quality and safety throughout their shelf life.