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Impact of PAT on the Use of Statistics

Impact of PAT on the Use of Statistics. Lynn Torbeck Lynn@Torbeck.Org. FDA Position. Clearly promoting the use of statistics: “…new strategy is to alleviate the fear.” Avoid regulatory impasse. “best principles of quality management.” “manage variability”

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Impact of PAT on the Use of Statistics

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  1. Impact of PAT on the Use of Statistics Lynn Torbeck Lynn@Torbeck.Org www.Torbeck.Org

  2. FDA Position • Clearly promoting the use of statistics: • “…new strategy is to alleviate the fear.” • Avoid regulatory impasse. • “best principles of quality management.” • “manage variability” • “an opportunity to use more rigorous statistical principles for a quality decision” www.Torbeck.Org

  3. FDA Training in Statistics • PAT Certification Program for FDA Investigators and Reviewers • Data handling and basic statistics • Regression and correlation • Statistical Process Control, SPC/SQC • Statistical sampling • Design of Experiments, DOE • Process capability www.Torbeck.Org

  4. Application Areas as in PAT • New Product and Process Development • Manufacturing / Production • Quality Assurance and Control • Using current data collection: • Jeff Davis of Genentech • Robert Chisholm of AstraZeneca • Richard Poska of Abbott Labs www.Torbeck.Org

  5. Major Areas of Statistics • Basic Statistics: • Descriptive Statistics, Avg, S, graphs • Inferential Statistics, t-tests. C.I. • SPC/SQC tools and techniques • Design of Experiments • Regression and Model Building • Multivariate Analysis www.Torbeck.Org

  6. Statistical Terms Used in PAT • Basic Statistics: • Manage variability • Reference distributions • Randomization • Confidence intervals • Correlation • Capability of process control • Statistical and risk analysis www.Torbeck.Org

  7. Statistical Terms Used in PAT • Design of Experiments: • Factorial design of experiments • Multi-factor relationships and systems • Orthogonality • Interactions defined • Response surface methodologies www.Torbeck.Org

  8. Statistical Terms Used in PAT • Multivariate Statistical Tools: • Multivariate mathematical approaches • Multivariate statistical process control • Pattern recognition tools • Model predictions • Regression analysis www.Torbeck.Org

  9. Chemometrics • “…the art of extracting chemically relevant information from data provided in chemical experiments.” S. Wold • “…the science of relating measurements made on a chemical system to the state of the system via application of mathematical or statistical methods.” B. Wise www.Torbeck.Org

  10. Chemometrics Tools • Design of Experiments • Time Series Analysis • Multivariate correlation • Multivariate regression • Partial Least Squares • Principle Component Analysis • Mathematical Pattern Recognition www.Torbeck.Org

  11. Areas of Strength • ASQ/FD&C Division • USP Statistics Expert Committee • PhRMA Statistics Committee • Leading Companies • Abbott • Genentech • Lilly www.Torbeck.Org

  12. Further Reading • “Impact of PAT Implementation on Product and Process Specifications.” • Jean-Marie Geoffroy • Abbott Labs • American Pharmaceutical Review www.Torbeck.Org

  13. Further Reading • “Risk/Science-Based Approach to Validation: A Win-win-win for Patients, Regulators, and Industry.” • Karen A. Welch • Conrad A. Fung • Stephen R. Schmidt • PDA Journal, Vol. 58, No. 1, Jan/Feb 04 www.Torbeck.Org

  14. Further Reading • “Process Analytical Technology and Multivariate Statistical Process Control.” • By Theodora Kourti • McMaster University, Ontario • The Journal for Process Analytical Technology • Vol. 1, Issue 1, Sept/Oct 2004 www.Torbeck.Org

  15. Further Reading • “Process Analytical Technology: Concepts and Principles.” • Mark L. Balboni • Pharmaceutical Technology • October 2003, p 54 www.Torbeck.Org

  16. The Impact of PAT • Few presentations at meetings • Few journal articles • Early adopters are all ready on board • Too soon to tell for the majority? • A need for real case studies • Publish your successes! www.Torbeck.Org

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