Process Optimization Services
Enhancing Pharmaceutical Processes From Design and Development Through Validation and Commercialization
Regulatory guidelines are clear that a manufacturer must ensure patient safety across the product lifecycle via the establishment of quality processes. Successful validation of complex manufacturing processes requires a thorough understanding of all process inputs. Poor understanding of a manufacturing process can lead to poor performance, excessive waste, significant regulatory risk, and, most critically, manufacturing delays. Process optimization establishes confidence that manufacturing processes are stable and capable.
ProPharma Group’s process optimization methodology is tailored to enhance our clients’ understanding of their manufacturing processes to ensure a smooth transition from design and development through validation and commercialization. We work with you to understand the resources you have invested and to utilize that as the foundation for our plan of action. Using a risk-based approach, we translate your risk tolerance into action plans that focus on the vital few inputs and controls, where risk is understood and managed across the organization in sync with regulatory expectations. Whether you need confidence in your Phase I clinical supplies or need to resolve an issue that may be threatening the continuity of your commercial supply, ProPharma Group has the expertise to optimize your manufacturing processes at any point in the product lifecycle.