Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 2. Practical SPC Rules to Apply on Pharmaceutical Process Data
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.
IAMCHAMP - STOCK.ADOBE.COM
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.
Click here for a PDF of the article.Click here for a PDF of the article.
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.
Full Tolerance Coverage Method for Assessing Uniformity of Dosage Units with Large Sample Sizes
March 10th 2025The ‘full tolerance coverage method’ is introduced as a coverage estimation approach for assessing the uniformity of dosage units from large sample sizes, ensuring that no dosage unit exceeds the specification range.
Inspiration Over Desperation: Accurant Biotech CEO Talks Leadership, Innovation, and Motivation
March 4th 2025Xiao-Yan Cai, PhD, shares insights into her leadership style, the importance of motivation in the workplace, and how she balances repetition with innovation, discussing how hobbies and resilience uniquely shape her professional approach, emphasizing the value of perseverance and preparation in both science and life.
