Innovation, cGMPs, and PAT

Pharmaceutical Manufacturing magazine’s On Pharma blog had an interesting post last week entitled Silencing Pharma’s cGMP high priesthood. The post pointedly asks:

We all know that cGMPs are essential to safety. But has the industry gone too far with them? Has pharma, in effect, created a high
priesthood of cGMP that stymies creativity, and even common sense?

This post references a Pharmaceutical Manufacturing editorial by Emil Ciurczak who makes the argument:

But, in some cases, cGMPs: have become laws to follow without question. Just as many religious people may not really know why they perform certain ceremonies, many scientists today don’t know why they do many things. Ask them and you may hear an answer very close to “It is written!”

I ran this by Christie Deitz, a senior principal engineer in our Life Sciences organization that you may recall from an earlier post on executing S88 projects. Christie believes that this viewpoint has many subscribers and has some elements of truth to it.

She reminded me that this is on of the key drivers for the Process Analytical Technologies (PAT) initiative from the Food and Drug Administration. PAT, a risk-based regulatory framework, is one of
the initiatives in the FDA’s GMPs for the 21st Century program.

The intent behind this initiative is to break down some of the barriers preventing pharmaceutical manufacturers from using current technologies to improve the quality of the products manufactured. An added benefit is that these technologies can also reduce the cost of manufacturing through improved cycle times and other process efficiencies. One example where this has happened is Baxter’s use of model predictive control to improve solvent recovery.

Another example where today’s technologies can help maintain high quality is Talecris Biotherapeutics’ use of smart devices and digital bus technologies like Foundation Fieldbus to monitor on-line analyzers and generate “GMP
critical alarms” in real-time for anything out of tolerance.

While there is some truth to the statement in the On Pharma blog, many in the industry, including the FDA, are working to change the “cGMP high priesthood” mentality. And, many Life Science manufacturers are beginning to take advantage of the risk-based regulatory framework and are using current technologies to improve their manufacturing quality and improve their overall operational performance.

Posted Wednesday, July 19th, 2006 under Life Sciences.

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