A Consistent and Reliable Approach to Analytical R&D
Methods for characterizing new drug substances and intermediates, as well as methods for monitoring chemical processes used to make new drug substances, are identified and developed in Analytical R&D. Such analytical methods ensure that samples of new drug substances used for preclinical and clinical evaluation meet requisite quality benchmarks.
Inference for QbD provides Analytical R&D teams with the following benefits (categorized by team member role):
Analytical Scientists
- enjoy a consistent approach to identification of analytical parameters critical to analytical method performance in analytical methods using the standardized and validated Inference for QbD function library
- employ a reliable approach to identifications, visualization, documentation and verification of analytical method design space using the Inference for QbD template library
- gain valuable analytical method understanding from low-value analytical data using machine learning methods
- save time by automating repetitive QbD tasks, e.g. creating standard analyses reports and capturing them in an electronic lab notebook
- save time by rapidly prototyping, testing and deploying new data-analysis methods for QbD applications
- shorten turn-around time for delivery of custom analytical reports by enabling the scientists to perform data pipelining and documentation directly in Inference Word
- easily find and reuse prior QbD information from a global searchable database of QbD data-analysis methods for assembly into SOPs
Analytical Managers
- deploy a consistent approach to implementing QbD goals across Analytical R&D
- ensure consistent, accurate and traceable Analytical QbD records and reports
- shorten time-to-decision and improve efficiency by providing streamlined, regulatory compliant Analytical workflows
- improve Analytical R&D’s capability to share and collaborate on QbD projects
- leverage and exploit an underutilized asset: QbD information from prior Analytical projects
- collect a broadly accessible, enterprise wide analytical R&D knowledge base for training new employees and initiating future QbD projects
- improve decision quality and reduce time-to-decision by supplying facts-based predictive modeling of analytical methods to entire R&D team
- shorten QbD training by using templates and leveraging familiarity with Microsoft Office
Adjoining Development Functions
- clearly communicate QbD project status, uncertainties and development strategy to senior stakeholders and the entire development team
- enable adjoining development functions involved in QbD project to have real-time access to relevant analytical R&D information
- support regulatory by maintaining QbD study data in a searchable 21 CFR Part 11 compliant centralized repository with full audit trails
- enable regulatory and CMC project teams to easily assemble standardized QbD results for CMC filing
- support process engineering during scale-up and validation by enabling direct access to analytical QbD information
- support IT by providing: a single platform that spans the full development organization; a standards-based architecture that is scalable to thousands of users; and a set of core applications that requires minimal training and support built on familiar Microsoft Office