Difference between specification and limit in pharmaceuticals
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Specification limits are the targets set for the process/product by customer or market performance or internal target. In short it is the intended result on the metric that is measured.
Control limits on the other hand are the indicators of the variation in the performance of the process. It is the actual values that the process is operating on. It is the real time value.
Control limits on the other hand are the indicators of the variation in the performance of the process. It is the actual values that the process is operating on. It is the real time value.
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The below diagram shows how, Specification limits and Control limits can vary:
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