Incentivizing a Culture of Quality

From the lab to commercial process and across the global supply chain, quality is a gift we all can share

By Steven E. Kuehn, Editor in Chief

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I’ve come to understand that fall is Pharma’s busy season for meetings and conferences and the seasonal home of three biggies: Pack Expo, the International Society of Pharmaceutical Engineers and the American Association of Pharmaceutical Scientists. Each of these “events,” for want of a better all-encompassing label, was attractive to both broad and distinct constituencies across the pharmaceutical manufacturing universe, offering attendees multiple forums to discuss myriad opportunities to collaborate with a capital “C.”

At this fall’s meetings, several pharmaceutical “communities” including operational,scientific, regulatory, financial and administrative, came together to share and disseminate new ways to collaborate in pursuit of making high quality, safe, affordable and effective drugs.

Pharma’s communities are inexorably linked — always have been — but it’s becoming increasingly clear that these groups have, by necessity, moved closer to one another to face the industry’s biggest challenges, including combating counterfeiting and managing risk and quality across global supply chains.

However, there are those out there who either don’t care for some reprehensible personal sociopathic reason like greed, or won’t care due to some institutionalized rationale; i.e., not my job, above my pay grade, etc. Regardless of the source of this malfeasance, the rest of us, including regulators, must work all the harder to stop the bad apples and criminal elements at work undermining the global pharmaceutical industry, and incentivize a culture of quality across all the world’s borders.

A study by the International Journal of Clinical Practice reported last year that the counterfeit drug business doubled between 2005 and 2010 reaching $75 billion in annual sales. Compounding this is the fact that consumers often purchase fake drugs online, dangerous because counterfeits often lack active ingredients and are contaminated with arsenic, boric acid, floor polish, chalk, brick dust and metals, just to name a few. Unfortunately, the impact and dangers of poor quality and counterfeit drugs is disproportionately felt by consumers in developing countries. About 30% of brand-name drug sales in developing countries are counterfeit, says the Center for Medicine in the Public Interest.

The expanding global pharmaceutical supply chain introduces its own problematic dynamic. In his special report (“Taming the Supply Chain Monster,” p. 18), contributor Angelo DePalma finds that it’s going to take a lot of cooperation from the global Pharma community, including regulators, to fight for drug quality. The U.S. Food and Drug Administration’s Safety and Innovation Act (FDASIA) of 2012 is attempting to address a number of quality issues including securing the global supply chain through Title VII. Today, companies import nearly 40% of finished drugs, and 80% of APIs and other ingredients, from more than 150 countries. Regulation and oversight, says DePalma, is lax by U.S. standards, in all but a handful of foreign jurisdictions.

In just the last decade pharmaceutical imports have quadrupled, says DePalma. More entities than ever “touch” materials and products, which frustrate meaningful global enforcement. According to the FDA, Title VII can achieve its goals through application of tools the agency already uses such as data collection and analysis, risk-based decision-making and facility oversight, as well as close collaboration with foreign regulators — and therein lies the rub, because in practice, the global collaboration enforcement calls for is far from certain and yet to be proven effective.

To ensure the quality and efficacy of the world’s pharmaceutical supply is going to take an enormous collaborative effort, and every pharma community must participate. From Big Pharma controlling extended supply chains and regulators, to the engineering and vendor community providing the technological infrastructure to support quality and compliance. Everyone knows good health is a gift beyond value, and the industry is striving to deliver it worldwide to all — sort of like Santa Claus — but on every night of the year.

Steven E. kuehn, Editor in Chief
skuehn@putman.net

Published in the December 2013 edition of Pharmaceutical Manufacturing magazine

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