This booklet includes below chapter is taken from PDA's bestselling Pharmaceutical Quality, and offers an examination of quality from the perspectives of senior experts working in industry, government and academia from around the world.

Using Statistics to Measure and Improve Quality

This booklet is an introduction to the application of applied statistics to quality assurance, quality control and manufacturing under the Current Good Manufacturing Practice regulations (CGMPs) for the pharmaceutical, biopharmaceutical and related industries. Specifically, the focus is on those statistics that are most useful in working within the context of 21CFR 210 and 211 (FDA, 2001).

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 1.05 MB)

Paper version is not available.

Table of Contents:

Preface
Introduction
Statistical Thinking
Statistics in Context with Pharmaceutical Quality
Statistical Tools
The Role of Quality Assurance and Statistics
The Role of Manufacturing and Statistics
Definitions of Quality
Fads in Quality
Data Collection
Standards versus Specifications
Setting Specifications
Out of Specifications
Incoming Inspection
In-Process Inspection
Finished Product Inspection
Process Validation
Process Control
Method Validation
Stability Program
Annual Review Program and Trending
Resources
Software for Statistics
Summary
Future Vision
References
About the Author