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July 2009

Legal Risks Affecting Blood Banks

Blood establishments should make CGMP compliance a top priority because the risks associated with systemic or persistent non-compliance are significant. FDA has an array of options: the agency can subject an establishment to repeated inspections, issue warning letters, seize product and sue for injunctive relief. If an establishment's compliance problems are particularly egregious, there is also the risk of criminal liability.

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Designing a Winning CAPA System

Various sub-system elements of a Quality System (QS), business and manufacturing processes produce nonconformances. All relevant QS sub-systems must be designed to identify and correct their nonconformances. These QS sub-systems are also expected to operate within a state of "control." These QS sub-systems are unique and separate entities from the CAPA System, which is also a QS sub-system. There is, however, a hierarchical relationship between these QS sub-systems. QS sub-systems that produce nonconformances must have the ability to analyze and appropriately escalate nonconformances that are identified as either "high risk" or are the result of "out of control" process conditions.

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AABB Annual Meeting & TXPO 2009
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GMP & FDA Compliant Quality & Doc Systems 2009
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Did you know that a high percentage of the FDA's 483s notices are directly related to CAPA issues? Did you also know that your CAPA system relies almost entirely--at least initially--on the effective management of events such as nonconformances and deviations?

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