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A 50 percent increase in drug recalls in the past year is raising fears over the quality of drug manufacturing in the US. Read more...

With critics questioning whether regulators give medical devices enough scrutiny before approving them for patients, University of Minnesota law Prof. Ralph Hall pored over seemingly obscure regulatory data to determine whether the allegations are true. Read more...

The recent economic challenges have led many companies to revisit their view of risk management. Among other areas of risk, many had to rethink their approach to low-cost country sourcing. Read more...

The federal transparency campaign is reshaping drug research, production, regulation, and marketing on multiple fronts. Read more...

The structure and content of ICH Q11 on drug substance development and manufacturing is taking shape as the Expert Working Group (EWG) resolves the challenging issues around the guidelines breadth and depth and its relationship to the other guidelines in the ICH quality family Read more...

Infusion pumps rank in the top ten of both the FDA’s medical device adverse event list and the medical device recall list. But 87 recalls in the last five years have not produced the next generation of devices. Read more...

Without a quality system, quality assurance is at best a guess, with no basis for continuous quality improvement. Read more...

The FDA has made some big changes in the final version of their Frequently Asked Questions (FAQ), Statement of the Investigator (Form FDA 1572) Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (May 2010). Read more...

No regulated business wants to receive an FDA Warning Letter (or Form-483) of Inspectional Observations. In such controlled industries as food, agriculture and pharmaceutical, receiving a list of deficiencies can feel like a heavy blow to your quality system. Read more...

Before discussing company-wide Quality Management systems, it is necessary to define the definition of Quality Management (QM). Many organizations and other groups of individual people have attempted to define QM. There are several different operational definitions of quality that are commonly used in many industries. Read more...

Quality Management Systems, such as ISO 9001, serve as the foundational building blocks for an organization and provide well defined and documented procedures which improve the consistency of outputs. Yet, the Quality Management System alone cannot accomplish a system of closed loop corrective actions and instituted lessons learned. Read more...

While supplier audits are not new, many companies have conducted more of them in recent years as they sourced more from suppliers in low-cost regions and because of last year's economic downturn, which challenged the financial solvency of some suppliers. Read more...

As seen in the Warning Letter Report issued by the European Compliance Academy (ECA) observations in "Production Record Review" (21 CFR §211.192) are among the most frequent GMP deviations cited by the U.S. Food & Drug Administration (FDA). Read more...

The FDA announced the launch of its newest initiative, FDA-TRACK, this week. The initiative is designed to help measure the agency’s performance through using a series of quantifiable benchmarks that would give congressional appropriators a clear understanding of how well the FDA uses its money. Read more...