Using Applied Statistics to Study a Pharmaceutical Manufacturing Process

Tiani, John P

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Using Applied Statistics to Study a Pharmaceutical Manufacturing Process

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The pharmaceutical manufacturing process of interest produces a suspension for inhalation. Currently, the product is manufactured on two lines. A third and fourth line are in the process of being commissioned and plans are currently in place to construct three additional lines. The manufacturing lines operate independently of one another. Each manufacturing line consists of two actives compounding tanks so their utilization can be rotated to improve manufacturing capacity. The objective of this project was to study the content uniformity assay values for the 0.25 mg/mL (0.5 mg) manufacturing process through the application of statistical techniques. The study focused on three separate topics: 1. Monitoring process behavior for content uniformity assay values 2. Ascertaining the equivalence of batches manufactured on Line 1 vs Line 2. 3. Monitoring the signal to noise ratio of the content uniformity assay values In order to accomplish the three tasks above, the following statistical techniques were applied: 1. Control chart techniques were applied to the data, including standard control chart techniques (x-bar and S), individuals control chart techniques, and modified limits. 2. An equivalence test for the means of the two processes was conducted. 3. A new control chart, the SNR chart, was developed and implemented. The results/conclusions of the application of statistical techniques were: 1. The content uniformity assay values were in statistical process control with respect to modified limit control chart techniques. 2. The Line 1 and 2 data were statistically equivalent. 3. The quantity (x-bar / s) was in statistical process control. The SNR control chart displayed superior performance to the Individuals control chart.

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