A Consistent and Reliable Approach to Pharmaceutical R&D
Drug candidate dosage forms (e.g., tablet, capsule) are developed through Pharmaceutical R&D. Extensive and thorough physico-chemical and mechanical characterization of drug active and formulated dosage form is required to produce a drug candidate that is suitably bioavailable and stable for use during clinical evaluation.
To obtain the characterizations needed, Pharmaceutical R&D employs preformulation studies (material characterization, morphic form identification, salt selection, compressibility testing, process and material compatibility testing) and formulation development (formula selection, process selection, optimization and the formulation cycle, intermediate and product characterization, stability testing for regulatory purposes). Proper integration of these phases is essential to achieve “Quality by Design” because data from each phase is used to control the next step in the development process.
Inference for QbD provides Pharmaceutical R&D teams with the following benefits (categorized by team member role):
Pharmaceutical Scientists and Engineers
- enjoy a consistent approach to identification of pharmaceutical material and process parameters that are critical to product quality using the standardized and validated Inference for QbD function library
- employ a reliable approach to identifications, visualization, documentation and verification of formulation material and process design space using the Inference for QbD template library
- gain valuable formulation process understanding from low-value formulation material and process attributes data using machine learning methods
- save time by automating repetitive QbD tasks, e.g. creating standard dissolution 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 formulation development 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 formulation process methods for assembly into SOPs
Pharmaceutical Managers
deploy a consistent approach to implementing QbD goals across Pharmaceutical R&D
ensure consistent, accurate and traceable formulation development QbD records and reports
shorten time-to-decision and improve efficiency by providing streamlined, regulatory compliant formulation process workflows
improve Pharmaceutical R&D’s capability to share and collaborate on QbD projects
leverage and exploit an underutilized asset: QbD information from prior formulation development projects
collect a broadly accessible, enterprise wide Pharmaceutical 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 formulation 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 formulation Pharmaceutical 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 formulation development 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