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June 2012

Peter Calcott

Is Quality by Design Just for Big Pharma?

by Peter H. Calcott
Ph.D., President, Calcott Consulting LLC & Senior

At last count, there have been approximately 35 submissions to FDA's CDER with full QbD packages covering all manufacturing operations. To date a few have been approved, notably Pfizer's own Chantix and Selzentry. In one case, the pre-approval inspection was waived and in the other, the inspection occurred but, as the company noted, there were no observations related to the QbD component of the submission. In both cases the concept of the design space was accepted, allowing the company to operate anywhere within this area without further regulatory approvals. Of course, the internal change control system would be used to assess and judge the change before the change could be implemented. So it appears that drug makers of small molecular weight drugs are off to a strong start, although it has taken quite a number of years to accomplish this.

Biologics or biotechnology drug manufacturers are clearly running behind with approximately six or so submissions of full QbD packages. To date, I am not aware of any full package having been approved. Why?

On analysis, there are two things that immediately surface. Firstly, small molecular weight compounds have been more successful than larger molecular weight drug companies. This is probably a reflection of the complexity of the manufacturing process for most biotech products where the number of unit operations is substantially larger than for most small molecular weight drugs. Thus, the development and data packages will be much more comprehensive and will take more effort to assemble and even to generate.

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The Importance of Computer Systems I/Os Accuracy Checks

by Orlando Lopez
Independent Consultant

How many times have we read an observation like this by the U.S. FDA? "Your firm has failed to exercise appropriate controls over computer or related systems to assure that the input to and output from the computer or related systems of formulas, other records, or data, are checked for accuracy [21 CFR 211.68(b)]. For example, your firm's custom software for your Master Batch Production record, referred to as the 'I-131 Database,' has not been validated. This software is responsible for generating the batch production record, performing calculations to produce varying concentrations of drug product, and generating label information for customer vials and lead pigs."

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Cindy Fazzi

Implementing a New System: Why Training Reinforcement is Critical

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

It all sounds familiar: You attend a training course that you are excited about. You spend two or more days soaking up new information. You take notes diligently. Before you know it, the training is over. You go back to the office. And after a while, it happens: The new knowledge fades.

You're not alone. It is estimated that up to 80 percent of what we learn from training courses are lost within 30 days—unless the knowledge is reinforced. This is true for the CAPA-investigation class that you attended and the software training on the new quality system that your company is implementing.

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Did you know how bizarre medical advice and medical advertising have often been in the past? With medical device and pharmaceutical professionals working hard to make a positive difference, it's often interesting, and even outright hilarious, to take a look back at the medical advice/remedies of the past and to realize how far life science professionals have progressed.
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