Guidance for Industry
ANDAs: Blend Uniformity Analysis - Part- I
I.
NTRODUCTION
II.
SCOPE
III.
SAMPLING SIZE AND PROCEDURES
IV.
ACCEPTANCE CRITERIA AND ANALYTICAL
PROCEDURES . . . . . .
Guidance for Industry Part- I For BU
Click to download Below
Guidance for Industry Powder Blends and Finished
Dosage
Units Stratified In Process Dosage
Unit Sampling and Assessment
Guidance for Industry Part- II For Powder Blends and Finished Dosage
Click to download Below