I haven't come across any literature reference/clarifications on the following ...
Practically speaking, the change is more aligned with the control concepts and reflects the performance achievable by the process.
But, at first look, it seems FDA/USP allowed wider variability in the batch?
How do these criteria correlate with each other (obvious current criteria must be better, but how?)
FDA has changed the acceptance criteria for following test parameters:
Dissolution
Previous: NLT Q%
Current criteria are at three levels...
S1 :- 6 units...no value is less than Q+5
S2 :- 12 units...AVG >= Q; no value is less than Q-15
S3 :- 24 untis...AVG >=Q; no unit less than Q-25; NMT 2 units < Q-15
Content Uniformity
Previous : 85-115 % + RSD < 6%
Current criteria are at two levels..
L1 :- AV < 15...
L2 :- AV < 25
(for calculation of AV...detailed steps are described in USP... ...)
Practically speaking, the change is more aligned with the control concepts and reflects the performance achievable by the process.
But, at first look, it seems FDA/USP allowed wider variability in the batch?
How do these criteria correlate with each other (obvious current criteria must be better, but how?)
FDA has changed the acceptance criteria for following test parameters:
Dissolution
Previous: NLT Q%
Current criteria are at three levels...
S1 :- 6 units...no value is less than Q+5
S2 :- 12 units...AVG >= Q; no value is less than Q-15
S3 :- 24 untis...AVG >=Q; no unit less than Q-25; NMT 2 units < Q-15
Content Uniformity
Previous : 85-115 % + RSD < 6%
Current criteria are at two levels..
L1 :- AV < 15...
L2 :- AV < 25
(for calculation of AV...detailed steps are described in USP... ...)
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