AAPS PharmSciTech

, Volume 19, Issue 3, pp 1483–1492 | Cite as

A Science and Risk-Based Pragmatic Methodology for Blend and Content Uniformity Assessment

  • Naheed Sayeed-Desta
  • Ajay Babu Pazhayattil
  • Jordan Collins
  • Chetan Doshi
Brief/Technical Note
  • 117 Downloads

Abstract

This paper describes a pragmatic approach that can be applied in assessing powder blend and unit dosage uniformity of solid dose products at Process Design, Process Performance Qualification, and Continued/Ongoing Process Verification stages of the Process Validation lifecycle. The statistically based sampling, testing, and assessment plan was developed due to the withdrawal of the FDA draft guidance for industry “Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment.” This paper compares the proposed Grouped Area Variance Estimate (GAVE) method with an alternate approach outlining the practicality and statistical rationalization using traditional sampling and analytical methods. The approach is designed to fit solid dose processes assuring high statistical confidence in both powder blend uniformity and dosage unit uniformity during all three stages of the lifecycle complying with ASTM standards as recommended by the US FDA.

KEY WORDS

blend uniformity content uniformity dosage uniformity process validation solid dose lifecycle stages 

Notes

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no competing interests.

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Copyright information

© American Association of Pharmaceutical Scientists 2017

Authors and Affiliations

  • Naheed Sayeed-Desta
    • 1
  • Ajay Babu Pazhayattil
    • 1
  • Jordan Collins
    • 1
  • Chetan Doshi
    • 1
  1. 1.Apotex Inc.TorontoCanada

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