Why Life Science Manufacturers Do What They Do in Development, Formulation, Production and Quality: A History
- Published
- Dec 2015
- ISBN
- 1933722924
- Pages
- 455
- PDA Item Number
- Hardcover: 17333 | Digital: 18014
- Format
- Book
- Member Price
- $25.00
- Nonmember Price
- $25.00
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In a passionate retrospective of a successful career built on thinking statistically and applying that approach to quality in pharmaceutical manufacturing, Lynn Torbeck has created a "must-read" for anyone involved in product development, formulation, manufacturing and quality.
Each of the 45 chapters in this book addresses a specific aspect of applied statistics and provides pragmatic applications on such topics as:
- Can we save the Technical Conference?
- %RSD friend, Foe or Faux?
- OOS, OOT, OOC and OOSC
- Can AQLbe Zero?
- Outlier Management
- Why 5%?
- Design Space Circa 1987
- Quality by Design Circa 1982
- Training Scores
Because this book is not organized in a linear fashion, Torbeck encourages readers to dip into any chapter that is of interest. This book is not a statistics text per se; however, it shares the author's passion and decades of experience for statistics applied to pharmaceutical quality by showing how they can be used in real-world pharmaceutical quality problems.
Table of Contents
Table of Contents:
- Quality by Design Circa 1982
- Rugged and Rebustness Using DOE
- Valid Sampling Plans
- Reportable Values FOR OOS
- Statistical Thinking
- Preventing the Practice of Testing into Compliance
- Six Tools for Common Cause Variability Reduction
- Sector Charts
- Design Space Circa 1987
- Ten Deadly Statistical Traps in Pharmaceutical Quality Control
- Process Consistency and Variability Reduction
- Statistical Implications of the CGMPs, A 30-Year Retrospective
- USP <1010> Appendix E
- Outlier Management
- Square Root of (N) +I Sampling Plans
- Can We Save the Technical Conference?
- %RSD: Friend, Foe or Faux?
- The Role of Statistical Significance Tests
- Bergum's Method Recognized
- Thoughts on Probability for Risk
- On the Verge of Significance: Why 5%
- On Numerical Evaluations
- 100% Visual Inspection Goes Viral
- Walk Like a Statistician
- Can AQL be Zero?
- Implementing the Tools of Process Quality
- Statistics in the Service of Quality
- Tools in Waiting: Is it Time for EVOP?
- Pitfalls in Statistics
- Data Culture
- Absence of a Data Culture: "We Sent You the Good Ones"
- Reducing Risk in Risk Management
- Reducing Biological Variation
- OOS, OOT, OOC and OOSC
- Deviation Data Summary Report
- Secrets to Variability Reduction
- Is ICH Q9 a Failed Document?
- Why XBar ± 3S is not a Universal Solution
- Representative Sampling
- Placket-Burman Designs
- A Review of ICH Q10 Pharmaceutical Quality System
- Process Capability Indices
- Compositing Samples
- Observations on USP-NF <905> Uniformity of Dosage Units
- Reading and Activities
About the Authors
About the Author
Lynn D. Torbeck, started Torbeck and Associates in 1988 providing training and consulting in applied statistics and experimental design for pharmaceutical and biopharmaceutical development, quality assurance and control. Specific effort was targeted to process and method validation under cGMPs. Publications include many journal articles, books and chapters. Specifically, Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab®, Validation by Design and Square Root of (N) Sampling Plans as well as a chapter in Pharmaceutical Quality titled Using Statistics to Measure and Improve Quality.