SIR #: 406
Section: V1M5, Section 126.96.36.199 (b)
V1M5: 188.8.131.52.b.i states, "All media shall be tested for performance (e.g., for selectivity, sensitivity, sterility, growth promotion, and growth inhibition). These tests shall be performed at a minimum with first use."
Is the intention to require that the 'minimum' testing MUST be performed during/with first use, or is 'before first use' acceptable?
TNI FINAL RESPONSE:
Performance testing is required to be performed before the first use, or with the first use. The laboratory may determine the approach they prefer.