Guidance for Industry about Analysis Plan : Part- I For BU & Part- II For Powder Blends and Finished Dosage - My Hope Portal

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Guidance for Industry about Analysis Plan : Part- I For BU & Part- II For Powder Blends and Finished Dosage



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


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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

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