White Paper: The Power of Control Charting

Measurements are taken at many points throughout the process of pharmaceutical manufacturing. This begins with incoming raw materials and continues through the batching and packaging operations. Concentration of active ingredients, ll weights, container weights, closure torques, and metered dosing are all critical parameters that must be measured. Each of these measurements exhibit variation due to both special causes and normal statistical fluctuations. It is therefore desirable to monitor this variation in order to detect trends or failures in the system that lead to unacceptable product quality.

There are many types of control charts that can be employed, and the choice of which chart to use depends on sample sizes, the type of data collected (i.e., attribute vs. variable), and the information that is desired. Two common charts that are utilized in industry are the X̅ -R Chart and the I-MR Chart. Each of these charts will be covered in detail below.