From the Editor: There’s Room for All at the Table — Isn’t There?

Should any single group have a monopoly on science-based standards?

By Agnes Shanley, Editor in Chief

Our magazine has been privileged to cover some of the changes going on, or at least being talked about, in drug manufacturing. The IFPAC 2008 conference in Baltimore last month brought together many of those who are most anxious to see Quality by Design and Process Analytical Technologies (PAT) become part of the fabric of every day pharmaceutical plant operations. Those who have led these efforts, both at FDA and within industry, were at the meeting in full force, and several of your peers shared some of their experiences in applying the concepts.

Consultants also offered insights, and one of them even tackled the challenging topic of legacy products and how to apply QbD (or quality by redesign) to improve them. You’ll find interviews with some of these mavericks on our web site. Behind all the enthusiasm and the sharing of best practices, however, were some subtle dissonances.

This was evident whenever the topic of standardization came up. Two camps are becoming entrenched: the “anticompendial” side, which dismisses some of the USP standards as too old-fashioned to fit the new paradigm, and the compendial side, which views E-55 standards as too unstable and revolutionary to pass the test of time. It usually takes a group of young — or not-so-young — Turks to blast away established thinking. But in some cases, are they throwing out the baby with the bathwater? Is this conflict just adding to the confusion that already exists around ICH, QbD and the “Desired State”?

Both sides presumably present their arguments in closed committee meetings, but there has been little open, public debate. Perhaps there’s too little time? After all, it’s hard enough to work on one of these committees and juggle that with career and other responsibilities.

Progress, at times, must seem glacial (although E-55 has managed to put forth a number of standards in record time). Yet, some of the questions beg to be addressed and debated openly by those who will be using these tools.

Consider dissolution testing, an area where, after a few tiny explosions two years ago, we haven’t heard much discussion. E-55 has advanced the idea that calibration using USP’s baseline “tester tablets” is unscientific, and has promoted a mechanical calibration standard that each facility could adopt, based on the specifics of equipment at their plants. FDA has accepted the method as an alternative to using the tablets. Fine and good.

Variability has been seen in the USP baseline methods, but the alternative requires development of methods at each facility. FDA inspectors would then have to understand a different setup at each installation. Isn’t this the ultimate nightmare of “variability?” Then there is the question of analytical methods for pharmaceutical-grade water.

Here again, each of the two camps accuses the other of putting commercial interests ahead of noble scientific goals. Finally, there is the whole issue of standard-setting by consensus, as advocated by E-55. It sounds great. On E-55, FDA has only one vote, just like any other member. Isn’t that the way it should be? After all, FDA helped create some of the gridlock that’s preventing more pharma companies from embracing new technologies and making real improvements.

But is that, on a deep, philosophical level, the way things really should be? Can the industry be counted on to police itself? Could the concept of real-time parametric product release ultimately put the fox in charge of the hen house? In the meantime, is it too naïve to propose that these two camps stop maligning each other, heal any rifts and work together on the important job of developing clear, easy-to follow standards for those on the front lines who struggle to make ICH a reality at their facilities every day?

E-55 has scored some significant goals for sciencebased manufacturing recently; so has USP, by updating chapters for PAT methods and instrumentation, and both groups are vital to the future of this industry. But what do you think? Send us an an e-mail with your comments.

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