VIEWS: 200 PAGES: 4 CATEGORY: Health & Safety POSTED ON: 7/18/2011
Corrective & Preventive Action (CAPA) systems have been in existence since the dawn of time. When a negative event occurs, one of the first questions is how and why did it happen? Depending on the impact of the event, there is an analysis or investigation of the event to determine all aspects of the "Why" and the "How". Although quite informal, this is a rudimentary CAPA system.Sometimes, no matter how well controlled, the input of the process fails to produce the expected output. A deviation or nonconformance has occurred. A deviation is defined as a departure from the expected input, in other words, a procedure was not followed, or a specification requirement was not met. A nonconformance, according to Part 820, means the non-fulfillment of a specified requirement. This requirement, like that of a deviation, indicates a procedure was not followed or a specification requirement was not met. When deviations/nonconformities occur, a system must be in place for evaluating the impact on quality, conducting an investigation to determine root cause, and following up to verify the root cause was properly identified .A Corrective and Preventative Action(CAPA) system must be in place to track these events until closeout of the event is completed.Medical product problems require a stringent and formal CAPA system. The original GMP regulations for devices & drugs were embedded within the regulations. CAPA systems were first formalized for devices in the "Quality Systems Regulation" and for drugs in ICH Q-10, "Pharmaceutical Quality Systems"The principles of handling deviations and nonconformities are the same for devices and drugs. For devices, the process is well outlined in the regulations. However, for drugs, the requirements are not so defined.
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