Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab (single user digital version)

Jun 2015
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A trend is a series of events or data collected, generally over time, that has an established and expected pattern. The trend can be observed or it can be based on theoretical models. Any departure from the trend is then an unexpected out-of-trend event. It is atypical and begs for investigation.

Trend analysis is good business and good science. The need for a trend analysis book is justified by the continued interest in presentations and discussions, both public and private, and the lack of a widely accepted, clearly defined approach by the industry that lends itself to consistent interpretation and uniform application.

Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab, a new publication by Lynn Torbeck, answers this call, contributing to an industry/regulatory dialogue and consensus that will serve and benefit all stakeholders, and patients in particular.

This book is for pharmaceutical professionals working in product discovery, development, manufacturing, quality assurance and quality control. It presents a basic introduction to data and Trend and Out-of-Trend definitions, and proposes terminology to clarify the use of the word "control" in several contexts. Outtakes from FDA warning letters, plant audits and investigations for trend and out of trend are presented to highlight the agency's viewpoint. Helpful graphs, charts and tables are also included throughout the book and in the appendices.

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Format: PDF (1 file 2.95 MB)

Hardcover is not available.

Book written in June, 2015

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

    1. Data Collection
    2. Data Concepts
    3. Data Variability
    4. Data Summaries
    5. Data Presentation
    6. Distribution Analyses
    7. Data Trending
    8. OOS, OOT, OOC, and OOSC
    9. Warning Letters Examples
    10. References

Appendix A Control Charts
Appendix B Tolerance Intervals — Parametric

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, 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.