This white paper from NSF consultant Richard Kettlewell builds on an earlier white paper from Pete Gough, which introduces the regulatory expectations for Stage 3 of the process verification lifecycle. This article poses questions to pharmaceutical manufacturers as to how and why the concepts of Stage 3 could be built into pharmaceutical quality systems.
Arguably products and processes were always subject to development (process design), and since the advent of validation as a concept in the 1980s, we have always validated them – to a lesser or greater extent. So, Stages 1 and 2 of the lifecycle have always been around, as has Stage 3 – or at least the expectation for it and we have tested, reported, reviewed change and periodically reviewed product and process performance, haven’t we?! The reality is that while we chose to believe that our annual or periodic review reports demonstrate the ongoing control and capability of processes, the brutal reality is that these reports are at best 12 months out of date, and any opportunity to leverage information about a batch manufactured 11 months ago evaporated as soon as the QC analyst recorded the batch as a pass!
To find out more about this topic, download the following white paper