Page 203 - Assurance of Sterility for Sensitive Combination Products and Materials

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4
6
5
1
2
3
Acceptance
number
N/A
N/A
0
1
0
1
0
0
Sample sized
Process simulations—initial performance qualification information with additional columns.
15,000
30,003
15,000
30,003
3000
N/A
N/A
300
corrective measures,
corrective measures,
corrective measures,
process simulation
of repeat of one
restart validation
restart validation
restart validation
consideration
Investigation,
Investigation,
Investigation,
Investigation,
Investigation
Action Case # used in the used in the in Table 7.7 calculation calculation Risk to the patient—Quantifying assurance of sterility 183
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