Wednesday 24 January 2018

MTS Recommends... Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements—Part II: By-Time-Point and Multivariate Control Chart 

 "In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets."

M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part II: By-Time-Point and Multivariate Control Chart," Pharmaceutical Technology 41 (12) 2017.

MTS Recommends... Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart

Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart 

"In Part I of this article series, the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies is investigated, and an improved approach is suggested."

M. Mihalovits and S. Kemény, "Methods for Identifying Out-of-Trend Data in Analysis of Stability Measurements–Part I: Regression Control Chart," Pharmaceutical Technology 41 (11) 2017.

Monday 8 January 2018

MTS Recommends... Data Integrity Metrics for Chromatography

Data Integrity Metrics for Chromatography

Dec 01, 2017
By Mark E. Newton, R.D. McDowall
LCGC Europe
Volume 30, Issue 12, pg 679–685

"The authors discuss metrics for monitoring data integrity within a chromatography laboratory, from the regulatory requirements to practical implementation."