T/R potency <5% [Regulatives / Guidelines]
❝ It was there in 2001 guidance as desired requirement-not mandatory... problem is that I can not find that 2001 (first) BE/BA guidance
❝ I can not find that 2001 (first) BE/BA guidance. Also in 2021 guidance lines 807-808
Correct the "should be within 5%" does exist in the FDA guidance (not the BE guidance for individual products). I was asked to provide the info last yr in a meeting...
- T/R potency <5% Achievwin 2022-09-07 18:22 [Regulatives / Guidelines]
- T/R potency <5% Helmut 2022-09-07 18:55