How are the Acceptance Criteria for Content Uniformity & Dissolution Superior?

[v9991]

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... ...)

 

[Stijloor]

Any FDA experts who want to comment?

Thank you!

Stijloor.

 

[v9991]

not exactly the precise answer, but an illustration of detailed approach of newer version can be found here...

http :// www. dmsc.moph.go.th/webroot/drug/km/DrugReg Slide/Uniformity of Dosage Units (BP 2011-USP 34).pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http :// www. njphast.org/PDF/Evaluating Content Uniformity NJPhAST Sep 22 2011.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http://cpb.pharm.or.jp/cpb/200111/c11_1412.pdf

http :// www .pqri. org/workshops/SampleSize/Bergum.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http ://www. pqri .org/workshops/SampleSize/PharmEuropa.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http://www.mbswonline.com/upload/presentation_7-6-2011-9-17-54.pdf

http :// www. fda.gov/ohrms/dockets/dailys/04/jan04/013004/03D-0493_emc-000003-01.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED

http :// www .dmsc.moph. go.th/webroot/drug/km/docs/uniformity.pdf - OBSOLETE BROKEN 404 LINK(s) UNLINKED