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DID YOU KNOW...

That substantial growth in clinical research has dramatically increased the volume of clinical data and the need for quality management software that meets FDA regulations?
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Especially for Pharmaceuticals

Malcolm J. Bertoni is establishing the FDA?s strategic vision for transforming regulatory operations, with its emphasis on the importance of electronic submissions. This is a hot topic for his department and for the life sciences industry.
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Especially for Pharmaceuticals


Especially for Medical Devices

After a record number of medical device recalls last year, the FDA is urging all device companies to double-check corrective and preventive action systems. Here are five tips that can help your company simplify CAPA documentation.
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Especially for Medical Devices



Especially for Blood / Biologics

FDA and blood community representatives recently met to discuss topics of mutual concern in the areas of donor and patient safety. The two groups presented and reviewed issues pertinent to their operations.
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Especially for Blood / Biologics



Ten Most Common Reasons for FDA 483 Observations and Warning Letter Citations

Most FDA 483 observations and warning letter citations involve one of the following:

  • Not having a quality control system that contains procedures that conform to FDA regulations;

  • Having a quality control system that contains procedures that conform to FDA regulations, but not following them; or

  • Having a quality control system that contains procedures that conform to FDA regulations AND following them, but not having adequate documentation to show that you?re following them.

By sending an FDA 483 Obs. or Warning Letter, the FDA is communicating to a medical device company that its procedures are (or may be) inadequate in a specific area for one of the above reasons and, therefore, that an FDA inspection is (or may be) necessary to ensure FDA compliance.

At a recent Intermountain Biomedical Association workshop held in Lehi, Utah, Barbara Cassens, Director of the FDA?s San Francisco District Office, identified ten specific FDA regulations for which medical device companies (as of July 30, 2007) most commonly receive FDA 483 Observations and Warning Letter citations indicating the possible need for an inspection in order to ensure FDA compliance.

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Five Top Deviation Management Challenges

During the research and development phases of a product’s life cycle, pharmaceutical companies that use paper-based or hybrid systems can wind up paying many times more than what it would have cost to install a centralized, electronic system for managing product discrepancies. According to an article titled, “Deviation Controls in Pharmaceutical R&D” (printed on the Genetic Engineering and Biotechnology News website):

There are numerous examples of products that took many years to research, develop, get approved, and finally, marketed, due in part to inadequate controls during the R&D phases. Products have been approved but could not be marketed because they could not be manufactured reproducibly according to the conditions of approval. Review of data from preclinical, clinical, and other product studies and investigations into discrepant results from laboratory and clinical studies revealed wide variations in product formulation, handling, manufacturing, and testing [italics inserted]. 1

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Upcoming Events

Check out conferences, trade shows, and other events for life science professionals.

AAPS Annual Meeting
(Nov. 11-15, 2007)

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Editorial Staff

Know the difference between IDE and IND? Between a 483 and a Warning Letter? How about GMP versus GTP?
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GxP Lifeline welcomes articles that are informative, interesting, and useful to life science professionals.
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