Page 204 - Assurance of Sterility for Sensitive Combination Products and Materials
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Risk to the patient—Quantifying assurance of sterility 183
Case # in Table 7.7 6 5 4 3 -- 2 1 --
Acceptance number used in the calculation 0 0 0 1 N/A 0 1 N/A
Sample sized used in the calculation 300 3000 15,000 15,000 N/A 30,003 30,003 N/A
Process simulations—initial performance qualification information with additional columns.
Investigation, corrective measures, restart validation Investigation, consideration of repeat of one process simulation Investigation, corrective measures, restart validation Investigation Investigation, corrective measures, restart validation
Action
Simulation runs affected by contaminated units w 1 1 >1 1 >1
Contaminated units in any of the three simulations w 1 1 >1 1 >1
Number of Units Tested <5000 5000 to 10,000 >10,000
Table 7.6 Minimum number of simulations 3 3 3
