I gave the following talk at Discovery Shenzhen 2019. This is on how Pharmacutical Companies can make data driven decisions using JMP Tools. I discuss two specific topics: Stability Analysis for degredation and setting expiration dates, and also assessing consistency in manufacturing, tracking and trending for products and processes. You can download my slides here too.
JMP Tools for Pharmaceutical Companies: Stability Analysis and Assessing Consistency in Manufacturing
Laura A. Higgins, Ph.D.
JMP Global Technical Enablement Engineer
JMP has multiple tools for to help Pharmaceutical companies achieve their goals. I will discuss two common challenges in the Pharmaceutical industry and show how to use JMP for analysis and decision making for two of these: Stability Analysis and Consistency in Manufacturing. For Stability Analysis, JMP has built in statistical tests for determining batch pooling using the ICH Guidelines. When data in non-linear, there are options for transforming data that allow for standard analysis. JMP also has a non-linear platform for fitting complex non-linear models and equivalence testing. JMP tools for monitoring and assessing consistency in a manufacturing process allow tracking and trending of operations and products. Interactive tools such as Control Chart Builder and Distributions facilitate deep understanding of single processes or products, including metrics to understand if specification limits are being met. Process Screening and Process Capability scale up to investigating multiple product or processes simultaneously. There are additional tools in JMP for identifying root causes when problems arise, as well as innovative tools for identifying drift in processes.