Introduction

12/3/01


Click here to start


Table of Contents

Introduction

Why Test Blend Uniformity?

Why Test Blend Uniformity?

Product Quality Research Institute

Blend Uniformity Working Group

BUWG Actions

Industry Practices Survey

Industry Practices Survey

Industry Practices Survey

Industry Practices Survey

Troubleshooting Guide

Public Workshop

Public Workshop

Public Workshop

Public Workshop

Desired Attributes of a BUWG Recommendation

PQRI BUWG Recommendation for the Use of Stratified Sampling to Demonstrate Blend & Dosage Unit Content Uniformity

PQRI BUWG Recommendation

Scope of Recommendation

Stratified Sampling

Stratified Sampling of Dosage Units

Process Development

Validation Approach

Process Validation

Process Validation

Justification of Blend Sample Sizes and Acceptance Criteria

Justification of Dosage Unit Sample Sizes and Acceptance Criteria

PPT Slide

PPT Slide

Justification of Dosage Unit Acceptance Criteria

Justification of Dosage Unit Acceptance Criteria

Routine Manufacture

Merging the cGMP Requirement with Compendial Release Testing

Definition of “Readily Complies” and Impact on Degree of Testing Required

Routine Manufacture

Justification of cGMP Compliance Sample Sizes and Acceptance Criteria

Alternative Approaches

Results of PQRI Datamining Effort

Objectives of Datamining Effort

Summary of Data Analyzed

Characteristics of Submitted Data

Test for Normality of Means

Comparison of Blend and Dosage Unit Content Uniformity Data

Comparison of Blend and Dosage Form RSDs

Blend RSD < 3%

Blend RSD 3-5%

Blend RSD ɱ%

Correlation Between Blend and Dosage Unit RSD

Comparison of Acceptance Criteria

Datamining Results: “Readily” vs. “Marginally” Comply

Acknowledgements

Author: Boehm