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 the change and periodically reviewed the product and process performance.

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the ongoing control and capability of processes, the brutal reality is that these reports are at best 12 months out of date, and any opportunity to leverage information about a batch manufactured 11 months ago evaporated as soon as the quality control (QC) analyst recorded the batch as a pass.

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