Most of us, however, live in a world of engineering and business decision-making where less is often just that, and no advance comes without concomitant loss. Tight resources mean a job less well done. Higher purities mean lower yields. Cost savings mean lower quality. And because they are more exception than rule, examples of this principle--when you can find them--are all the more compelling.
This issue of Pharmaceutical Manufacturing highlights two manifestations of "less is more" at work in the pharmaceutical and biotech industry. The first, our cover story (p. 14) on Bayer Biological Products' new facility in Clayton, N.C., examines how the companies' scientists and engineers were able to redesign their manufacturing process to paradoxically boost both yield and quality of immunity-boosting medications derived from a feedstock that is always in short supply--human blood plasma.
The other example is the work of the Audit Repository Center (ARC; http://www.auditcenter.com), a), a non-profit organization sponsored by PDA, The International Association for Pharmaceutical Science and Technology (www.pda.org). Contributing editor Nick Basta's article (p. 46) touches on the validation challenge that computer-based systems represent for drugmakers--and how the ARC can help.
In order to comply with FDA's validation requirements, both computer products/services software providers and pharmaceutical manufacturers using their products spend great amounts of upfront time and money on audits that go over plowed ground again and again. Fundamentally, the ARC concept is to provide a safe, secure repository of completed audits, available on a subscription basis--for significantly less investment than what a pharmaceutical or biotech company would spend to conduct an audit itself.
Users of the service spend less money, and because the audits are performed by qualified auditors within a standardized industry process (as set forth in the PDA Technical Report 32), audit quality is likely to be higher and more consistent, too.
According to ARC president Harvey Greenawalt, recent surveys of suppliers of computer products and services to the pharmaceutical industry show that the average cost for a provider to support an audit is approximately $9,000. This is only the direct cost for personnel and facilities to support the actual performance of the audit. It does not include costs due to lost productivity while personnel are involved in audit activities. The true cost of an audit can run from $13,000 to more than $20,000 for an audit that most likely has been completed and can be used over and over again. Access to an ARC audit, in contrast, starts at only $5,000, with volume discounts bringing the price down even more.
Timeliness is added appeal to the service, Greenawalt notes. "One subscriber has said that they can get the audit data from us and evaluate it in five to seven days "compared with the six to 10 weeks it would take them to do their own audit."
"The experience with ARC to date has been very positive," adds Kola Stucker, associate director, corporate quality for Bristol-Myers Squibb. "Not only is ARC a provider of audits, but ARC has worked with us in developing appropriate training for our quality and IT personnel.
"ARC is an extension of our business process," Stucker continues. "It is integrated into our model for the audit process and allows us to spend more time on the utility of the audit information as it impacts our procurement and validation activities rather than on the execution phase where the return is not as apparent."
Hmmm. Better audits, more timely and less expensive. More time to focus on core competencies. Mr. Browning, do I hear an amen?