Quality Intelligence
It appears that lately, the idea of Quality Intelligence has been a topic of growing interest among industry and the regulators. The concept should not be new to us, as the concept was originally introduced along with FDA Process Validation guidance more than 10 years ago as “Stage 3” continuous process verification (CPV). We may now be seeing more regulatory enforcement in this area, as regulators work hard to push companies to prevent the quality and manufacturing issues behind 62% of drug shortages in the United States. One recent, expertly written 483, for example, linked downstream re-occurring QC investigations with an upstream failure to evaluate “inter- and intra-batch variability” during process validation. As far as I can tell, this is new 483 language, and exactly what the patient expects.
Prevention of problems can only be fully realized when a site takes the gigabytes (terabytes?) of data they are required to retain as information, and translate them into “knowledge”. That sentence was easy for me to write… but is much more difficult for a site to “do”. As one of my heroes W. Edwards Deming would say, “by what means”? This is where things get tricky, but also (at least for me) is the fun part! Does a modern “Stage 3” CPV simply consist of continuously updated control charts with our CPPs & CQAs (and perhaps some other application commitment data points)? Nope.
What is knowledge?: GXP data/metadata/information becomes knowledge once put in the context of patient safety. It really is as simple as that.
By first understanding our processes, specifically sources of variability arising from:
· software & hardware,
· facilities & equipment,
· and personnel & documentation (see ICH Q9),
we can design a modern Quality Intelligence approach that takes available information behind sources of variability and works to reduce variation by acting on knowledge. This allows us to step off the treadmill (we are tired anyhow), and break through the barriers that prevent us from achieving a world-class manufacturing & testing facility.
Let’s get to it!
Pete
