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Featured Articles

December 2012


Erika LietzanLaura Sim

The U.S. Biosimilar Pathway Nearly Three Years Later

by Erika Lietzan and Laura Sim
Covington & Burling LLP

The statutory pathway for approval of biosimilars in the United States, established in March 2010 with the enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), represented the culmination of 10 years of stakeholder discussion of scientific and policy issues relevant to these products. Nearly three years after its enactment, however, FDA has not approved any biosimilars, debate about implementation of the statute continues, and many questions remain.

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Stacy Berkshire

Peeling the Onion to Improve Human Reliability

by Stacy Berkshire
Senior Director of Global Quality Programs, Perrigo

Humans will make mistakes. Industries have been focusing on strategies to reduce or even eliminate human error in efforts to keep consumers and employees safe. Pharmaceutical companies are responsible for ensuring that their products are safe, labeled correctly, have the correct strength, are pure, and are produced with good quality. In the pharmaceutical industry when deviations are identified as a result of an error, organizations follow a deviation investigation process to understand the root cause and put in a corrective action to fix the problem. Often, human error is identified as the cause. The problem is that in many cases human error is considered the root cause without a more in-depth investigation to understand why the human made the error. A "root cause" of human error leads to no further investigation which means the CAPAs (corrective and preventive actions) put in place may be neither relevant nor effective. Human error CAPAs often involve putting employees, many times skilled and/or veteran employees, through remedial retraining. This is not only frustrating for the employee who rolls her eyes when she is retrained on a job she has performed many years, but also does not solve the actual problem. And, because the true root cause was never identified, the human error almost always recurs.

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Cindy Fazzi

Developing a QMS: Should You Buy or Build?

by Cindy Fazzi
Marketing Communications Specialist, MasterControl, Inc.

When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

Either way, an organization must ask itself: Is it more cost-effective to build a homegrown system or to buy a proven and validated QMS? Which option is cost-effective not just initially but over the long haul?

"Building" a QMS means you will develop the system in-house, possibly with the help of consultants. You may write your own software from scratch, or use templates as a framework. Writing your own software gives you control over the development and expansion of the system. In terms of cost, you can build the system piecemeal, as funds and other resources become available.

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Did you know that biopharmaceutical research and development is underway for drugs that can treat diabetes and related conditions? A total of 221 drugs are currently in the R&D phase within the walls of many U.S. biopharmaceutical research companies. All 221 are currently in clinical trials or awaiting FDA approval.
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