Validation by Design: The Statistical Handbook for Pharmaceutical Process Validation (single user digital version)

Jan 2015
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

This book offers an overview of the statistical issues expressed and implied in the U.S. FDA`s Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008. The need for this book is illustrated by the many inquires the author receives about how to use and implement basic statistics and designed experiments, DOE, for pharmaceutical process validation. There is clearly confusion and concern about meeting general regulatory requirements and this book answers those questions. It is an invaluable resource for anyone concerned with statistical aspects of validating a drug, biologic or animal health manufacturing process.

Book written in January, 2010

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 7.55 MB)

Table of Contents

Table of Contents:

Click here to download>>>Detailed Table of Contents

1. Process Validation: General Principles and Practices
2. Analysis of Variance
3. Average
4. Cause and Effect Relationship
5. Confidence, Assurance Consistency and Significance
6. Control Charts
7. Coefficient of Correlation
8. Cpk
9. Cpk Confidence Intervals
10. Data
11. Data Analysis
12. Data Collection
13. Defining Quality
14. Designed Experiments
15. Histograms
16. Interquartile Range
17. Median
18. Mode
19. Normal Probability Plots
20. Outliers (Barr Case)
21. Plackett-Burman Designs
22. Process Capability
23. Process Mapping
24. Range
25. %Relative Standard Deviation
26. Representative Sampling
27. Root Cause Analysis
28. Sample Size
29. Samples
30. Sampling Plans
31. Scatter Plots
32. Short Run SPC
34. Standard Deviation, Standard Error Variance
35. State of Control
36. Summary Statistics
37. Time Plots
38. Tolerance Interval — Parametric
39. Tolerance Intervals — Parametric
40. Trending Data
41. Variability

About the Authors

About the Author

Lynn Torbeck is a statistician specializing in applied statistics and designed experiments for CGMPs, QA/QC, SPC, OOS, QbD, validation and manufacturing. He has been in the pharmaceutical industry for all of his career and president of Torbeck and Assoc. since 1988. Lynn was elected to the USP Statistics Expert Committee in 2001 and 2005 and is a coauthor of USP<1010>. He has been a member of the Editorial Advisory Board of Pharmaceutical Technology since 1999. He was a member of the PDA Scientific Advisory Board since 2002 and is past chairman of the PDA SAB OOS committee. He won the PDA's Excellence in Teaching Award in 1997 and again in 2007. He is the author of the book Using Statistics to Measure and Improve Quality published by PDA/DHI Publishing and is editor of the book Pharmaceutical and Medical Device Validation by Experimental Design published by Informa Healthcare. In his last industry position, he was the Director of Validation, worldwide QA, for G. D. Searle (now Pfizer). Previously, he held positions of Director of Technical Services, U.S. QA, and Manager of Physical Science Statistics in the company's R&D Division. He holds BS and MS degrees in Statistics.