July 2013

For Quality Companies

Disaster Recovery and Validation

by: Louis Rutledge, MasterControl Inc.

Disaster! Today’s business world shudders at the word. With the current random occurrences of hurricanes, super storms, earthquakes, blizzards, fires, flooding and sustained power outages, it is a wonder how companies can recover to survive all of the natural or modern threats to their daily business operations and collection of business data. Today’s business world is dependent on the data created and stored for many aspects of daily operations: financial data; product specifications; designs; testing records; and quality management systems (QMS) data are only a few examples. How can you protect your precious data in the face of all these threats?

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Ways to Ensure Supplier Compliance

by: Cindy Fazzi, MasterControl Inc.

Your suppliers are critical to your success. They can increase your company’s efficiency—in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

For example, Epimed International, a medical device company, received a warning letter from the U.S. FDA for quality violations involving its supplier. The FDA said in a 2012 warning letter that Epimed conducts acceptance testing on the radio frequency of thermocouple electrodes without knowledge of the device manufacturer’s original specifications from the initial manufacturer, or how changes made to the device (e.g., sterilization cycles) will affect the device.

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FDA GMP Inspectors Cite 70% of Dietary Supplement Firms

by: Josh Long, Natural Products Insider

During a three-year period, federal inspectors have cited seven out of 10 facilities that make dietary supplements for violating regulations intended to ensure products are safe and contain the ingredients that are listed on the labels.

A total 444 out of 626 inspections for cGMPs (current Good Manufacturing Practices) resulted in the issuance of a "Form 483," according to data Natural Products INSIDER obtained through a Freedom of Information Act (FOIA) request.

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