Story update 12/13/2011: Additional information was added to the first paragraph pointing out the connection between FDA requirements and statistical tools.

According to a September 2010 interview of Rick Friedman, director of the manufacturing and product quality division at the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, "There has been an uptick in the number of warning letters for [good manufacturing practices (GMP)] violations sent out over the last year." The FDA provides guidance that is supposed to help companies meet requirements, but the increase in warning letters suggests that companies are still struggling to create and document good process validation procedures. Without extensive statistical knowledge, the requirements for GMP can be mysterious and intimidating

Fortunately, many of the requirements that the FDA has relate to common statistical tools. In this article, I’ll introduce some of the common statistical tools you can use to meet FDA requirements:
• Measurement Systems Analysis
• Control Charting
• Capability
• Acceptance Sampling
• Stability Analysis

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