Reducing batch-to-batch variability using the Umetrics® Suite
Tasly, a leading Chinese provider of botanical drug products, has implemented SIMCA® and SIMCA®-online in order to control batch-to-batch process variability and to monitor the manufacturing process in real-time. After the implementation, the company is able to identify deviations from an ideal process and proactively take corrective steps, thereby ensuring consistent product quality.
All the process variables including the process parameters, quality attribute parameters, and equipment operating parameters were collected automatically and stored in a real-time database for six months. SIMCA® was used to generate a batch evolution model based on multivariate data analysis (MVDA). Then, after first using the model to study and understand the effect of variations in raw materials and operating conditions on quality parameters, the “good” data were selected as a basis for a “golden batch” model.
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