Research ArticleTechnology/Application
Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala and Andrew Barnett
PDA Journal of Pharmaceutical Science and Technology September 2021, 75 (5) 407-424; DOI: https://doi.org/10.5731/pdajpst.2020.011791
K. Rao Gurijala
NSF Health Sciences, Washington, DC
Andrew Barnett
NSF Health Sciences, Washington, DC

References
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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 75, Issue 5
September/October 2021
Statistical Method for Trending of Excursions in Clean Room Microbiological Monitoring Data
K. Rao Gurijala, Andrew Barnett
PDA Journal of Pharmaceutical Science and Technology Sep 2021, 75 (5) 407-424; DOI: 10.5731/pdajpst.2020.011791
Jump to section
- Article
- Abstract
- Introduction
- Determination of Action and Alert Levels Based on Historical Data
- Rationale for Using Percentile Method to Determine Action and Alert Levels
- Definition of Adverse Trends
- Determination of Adverse Trends in Quarterly and Annual Trend Analyses
- Determination of Adverse Trends at the Onset of an Excursion Result
- Type I and Type II Errors
- Trend Rules Based on Binomial Probability
- Ongoing Processes
- Mature Processes
- Intermediate Processes
- New Processes
- Handling of Adverse Trends
- Case Study
- Recommendations for Implementation
- Sample Trend Charts
- Discussion
- Conclusion
- Conflict of Interest Declaration
- References
- Figures & Data
- Info & Metrics
- References
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