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Featured Articles

February 2011

Why Baldrige Works

by Rose Almon-Martin
VP Performance Excellence, MEDRAD, Warrendale, Pa.

There's no doubt that the Baldrige Criteria drive excellent performance. Of course, the perennial question for any improvement approach is "What's the return on my investment?" Cargill, a $107 billion company that produces and markets food, agricultural, financial and industrial products and services, says Baldrige is a huge return on investment. Their divisions that use the Criteria achieve 130 percent of their earnings targets versus divisions not using the Criteria, who achieve about 82 percent of target.

MEDRAD, a global market leader in radiology and interventional cardiology, measures success through our corporate Scorecard, which are five benchmarked goals that drive exceptional performance for our three stakeholders: customers, employees and our parent company, Bayer. The Baldrige Criteria helped MEDRAD consistently deliver results to stakeholders during times of growth and during tough times.

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Jason Clegg

Effective Nonconformance Management Key to FDA and ISO Compliance

by Jason Clegg
Marketing Director, MasterControl Inc.

A product's quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved. This is particularly critical in products that have direct impact on public health and safety, such as medicines, medical devices, cars, household appliances, and other consumer goods.

For this reason, the proper handling of nonconforming products is incorporated in Food and Drug Administration (FDA) regulations covering drugs, medical devices and biologics. The proper handling of nonconforming products is also incorporated in ISO international standards which apply to manufacturers that produce a wide range of consumer goods.

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RAPS Annual Conference and Exhibition
October 23-26, 2011, Indianapolis, IN

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On January 25th the FDA published a new guidance: "Process Validation: General Principles and Practices." The Guidance provides the pharmaceutical industry with valuable information regarding process validation for human and animal drug manufacturing. The guidance also provides information regarding the manufacture of biological products and the manufacture of APIs (active pharmaceutical ingredients).
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