What should you do when no Resolution testing is required for 12 consecutive verified LOTs or if it is required, the QC data was upheld?

• A. Increase the QC density testing to one test per LOT
• B. Reduce the QC density testing to one test every two LOTs
• C. Skip QC density testing for 12 consecutive LOTs
• D. Maintain the current QC density testing frequency

Answer: (B)

When testing history shows consistent stability, you can adjust how often you sample. If you have twelve consecutive verified lots with no need for resolution testing—or if resolution testing was required but the QC data were upheld—that signals the process is behaving well and there’s less risk of hidden issues showing up in untested lots. In this scenario, reducing QC density testing to one test for every two lots balances maintaining adequate oversight with cutting unnecessary work and cost.

This step keeps monitoring in place without overdoing it, since continuing with the higher per-lot testing would add cost without a corresponding gain in protection, while skipping testing entirely would remove essential checks. Maintaining the current frequency would miss the opportunity to reflect the proven stability in a more efficient approach.