Drug stability analysis and consistency analysis of production processes_Laura HigginsSpeaker: Laura A. Higgins , JMP Global Senior Technical Engineer
Speech topic: Drug stability analysis and production process consistency analysis
summary:
JMP has many tools to help pharmaceutical companies achieve their goals. In this presentation, Laura will introduce two common challenges in the pharmaceutical industry and show how to use JMP for analysis and decision-making to achieve stability analysis of drugs and consistency analysis of production processes in the manufacturing field. In terms of stability analysis, JMP's built-in statistical test platform can determine batch pooling using ICH guidelines. For nonlinear data, data transformation can be performed in JMP before standard analysis. The nonlinear platform in JMP is used to fit complex nonlinear models and perform equivalence tests. By using JMP to monitor and evaluate the consistency of manufacturing processes, operations and products can be tracked and trended. Interactive platforms such as control chart generators and distributions help to gain a deeper understanding of products or individual processes, including indicators for understanding whether specification limits are met. Process screening and process capability platforms can investigate multiple products or processes at the same time. JMP provides some tools to determine the root cause of problems, as well as other innovative platforms for identifying fluctuations in processes.
