Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data

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Part two of this article series shows how traditional statistical process control rules can be relaxed or adjusted to allow charting and evaluation of real-life data of pharmaceutical processes with a reduced number of false alarms. Ten practical tools or measures are suggested for minimizing false alarms among process data plotted as is on charts, provided concurrent process performance and product quality are demonstrated. This pragmatic approach reduces the number of futile investigations of apparent innocuous process deviations and streamlines the implementation of the third process validation stage of continued process verification or ongoing process verification.

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Peer-Reviewed

Submitted: March 3, 2021
Accepted: May 3, 2021

About the Author

Raphael Bar, PhD, rbar@netvision.net.il, is a consultant at BR Consulting in Ness Ziona, Israel.

Article Details

Pharmaceutical Technology
Volume 45, Number 11
November 2021
Pages: 46–53

Citation

When referring to this article, please cite it as R. Bar, “Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process,” Pharmaceutical Technology 45 (11) 2021.