GXP

Understanding the New Focus on Statistical Process Control | IVT

At IVT's 2nd Annual Validation Week Canada, Eugenie Webster (Khblenikova) presented on the new regulatory focus on statistical process control (SPC). The regulatory expectations were discussed, including the purpose of the regulatory requirements, determining which processes need monitoring and control, and understanding manufacturing process variations. The basics of statistical process control were also taught, with focus on the benefits of SPC charts, the difference between common and special variation, different types of control charts and their uses, interpreting and reacting to SPC data, and correctly calculating process variability.

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