Causal Product & Process Mapping
Regulatory initiatives and frameworks such as ICH Q8, Q9, Q10 and effective product life cycle management have highlighted the need for a science-based causal and mechanistic understanding of all upstream and downstream processes to ensure safe and effective product.
The InSysteA's Causal Process & Product Mapping (CPPM) methodology allows for scientific mapping of the process structure while capturing multivariate cause-and-effect relationships between Process Parameters (PP), Material Attributes (MA) and Product Quality Attributes (QA) with observance of process feedbacks and dynamic process behavior and under consideration of all relevant circumstances (contexts).
The result are InSysteA's unique causal and mechanistic product & process models (CPPM Model).
The CPPM Model covers meaningfull contexts:prior knowledge & experience (refine, capture and make it available in a general accessible format), data and genealogy (upstream / downstream correlations, unit operations, CQA’s evolution, data structure), batches (sensitivity and variations) and sites (technology, equipment, operation & control spaces).
The applied tool (System Dynamics Vensim) allows any user to master multivariate process complexity in a practical and easy understandable way (sensitivity analysis and diagnosis, ...).
Consequently user (customer) will be in a position to master sources and multivariate relationships of variability of the product and process and associated risks with capability to predict their impact on product quality.
As a result, the user (customer) will be able to:
- identify the Critical to Quality parameters and enhance the definition of the process control strategy
- provide knowledge and risk based process design and development
- provide more effective tech transfer and process validation
- maintain a pro-active Product and Process Life Cycle Management
InSysteA posses consolidated knowledge and practical experiences with multivariate application of CPPM methodology through numerous successfully executed applications.
For more information, please contact us.