Drug Stability Analysis and Consistency Analysis of Manufacturing Processes_Laura HigginsSpeaker: Laura A. Higgins , JMP Global Senior Technical Engineer
the speech topic: Drug stability analysis and consistency analysis of the manufacturing process
Summary:
JMP has many tools to help pharmaceutical companies achieve their goals. In this talk, Laura will introduce two common challenges in the pharmaceutical industry and show how to use JMP for analysis and decision making in the field of pharmaceutical stability analysis and production process consistency analysis. In terms of stability analysis, JMP's built-in statistical testing platform can use ICH guidelines to determine batch pooling. For nonlinear data, standard analysis can be performed after data transformation in JMP. A nonlinear platform in JMP for fitting complex nonlinear models and performing equivalence tests. By using JMP to monitor and assess the consistency of the manufacturing process, operations and products can be tracked and trended. Interactive platforms, such as control chart generators and distributions, provide insight into a product or individual process, including metrics for understanding whether specification limits are met. The Process Screening and Process Capability platform can investigate multiple products or processes simultaneously. JMP provides some tools to determine the root cause of problems, and other innovative platforms that can be used to identify fluctuations in the process.
ConsistencyControl Chart BuilderDegradationEquivalence testingProcess CapabilityProcess ScreeningStability Analysis
