A short note on the application of ANOVA Technique in the Pharma Industry
A pharma client wanted to ascertain if the newly developed process for a new generic drug product is consistent and resulting in product with drug content uniform throughout the batch. As part of the validation exercise, several samples were withdrawn at different intervals of time and the client wanted to ascertain if the test results analysed at different times are with no significant difference.
The data for 150 samples drawn at 5 different times on an hourly basis was given by the client. The problem was to conduct statistical tests and provide inference. This problem converts to comparison of the means of the drug levels taken during the 5 different times. ANOVA(Analysis of Variance) technique was applied to the problem to check the equality of the means and Tukey’s Honest Significance Test was applied to identify the inconsistency of a specific group using Python.
From the ANOVA test, it was concluded that the drug content across the 5 different groups were not consistent. Also, the exact point of inconsistency was identified by using the Tukey Test.
It was recommended that the pharma client needs to revisit the manufacturing process to improve uniformity and consistency of product across the entire run of the batch. The pharma client took into account the solution provided and decided to revisit the manufacturing process. This recommendation greatly helped them in concluding on the suitability of the developed process.
