Once a test method or manufacturing process has been validated there is a continuing need to demonstrate that the procedure continues to operate in a manner that meets the validation requirements.
The recent guidance document on process validation has indicated that the Food and Drug Administration is expecting to see continuous process verification employed over the working life of a test method or manufacturing process. Statistical Process Control (SPC) charting has long been recognized as a method for monitoring processes of all types. This Video will discuss the application of SPC to attribute data, and present the rules used in the interpretation of the charts.
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Statistics for Quality Control and Process Validation Statistical Process Control SPC for Attribute | NatokHD