With the new FDA Process Validation Guidance and the revision of Annex 15 of the EU GMP Guide a new validation stage - Ongoing/Continued Process Verification - was introduced. In this stage the companies should demonstrate that the validated process is further in a "state of control". To demonstrate this "state of control" many companies use Statistical Process Control (SPC) and control charts.
In the October issue of the Pharmaceutical Technology Journal you can find part 1 of the article "Practical SPC Rules in the Real World
of an Ongoing Process Verification Plan"*. The author of this article is Dr Raphael Bar. Among other things, Dr Bar describes in his article, why the fundamental SPC rules are often not met in pharmaceutical or API producing processes. He also discusses whether data should be normally distributed and how to handle the "state of control” versus “state of statistical control".
These questions and the respective answers will also be part of a presentation Dr Bar will give during an ECA Live Online Training about the Trending of Process Data for OPV/CPV on 12/13 October 2021.
* R. Bar, “Practical SPC Rules in the Real World of an Ongoing Process Verification Plan: Part 1. Conventional SPC Rules and Pharmaceutical Process Data,” Pharmaceutical Technology 45 (10) 40–47 (2021)