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Compliance risks and package validation mistakes

Examining common medical device package development/validation errors, and five compliance risks facing life-science firms.

The end of the year often means looking back at key events that have occurred. Take the top 10 stories of 2009, for example. For music listeners there’s this year’s top 40 music countdown. For healthcare packagers, here are two far more practical “top” lists:

• “Top 10 Common Mistakes Companies Make When Developing and Validating Packaging Systems.” In Part 1, the Medical Device Package Testing Blog, authored by DDL Inc., lists loss of sterile integrity, cutting too many corners, package and product are not prequalified for compatibility, ignoring the worst-case scenario, and no time to develop protocols as the top five errors. Part 2 discusses mistakes six through 10. They include having the wrong sample size, using the wrong package type/material, squeezing oversized pouches into cartons, Tyvek separation is not recognized as a false positive, and accelerated aging is performed at high test temperature.

• On a broader note, the “Top Five Compliance Risks Facing Life Sciences Companies” is a report from Ernst & Young that brings a regulatory perspective that incorporates U.S. healthcare reform, the economic outlook, and risk management. An interesting kernel here: “Off-label use of medications is common in clinical practice and approximately one-fifth of all drugs are prescribed off-label.” The report recognizes that “companies are reducing staff and cutting costs,” yet concludes, “Companies that fail to adapt to the changing risk environment are sure to pay the price, whether it be in the form of penalties, legal judgments or reputational harm.” That equates to accomplishing more with less. Sound familiar?

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