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Quality by Design (QbD)

Quality by Design (QbD). Myth : An expensive development tool ! Fact : A tool that makes product development and commercial scale manufacturing simple ! Actually saves money ! How ?. Outline. FDA initiatives for quality The desired state Quality by design (QbD) and design space (ICH Q8)

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Quality by Design (QbD)

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  1. Quality by Design (QbD) Myth : An expensive development tool ! Fact : A tool that makes product development and commercial scale manufacturing simple ! Actually saves money ! How ?

  2. Outline • FDA initiatives for quality • The desired state • Quality by design (QbD) and design space (ICH Q8) • Application of statistical tools in QbD • Design of experiments • Model building & evaluation • Statistical process control • How can Innoworks assist you?

  3. FDA’s Initiative on Quality by Design • In a Quality-by-Design system: • The product is designed to meet patient requirements • The process is designed to consistently meet product critical quality attributes • The impact of formulation components and process parameters on product quality is understood • Critical sources of process variability are identified and controlled • The process is continually monitored and updated to assure consistent quality over time

  4. Process Understanding Continuous Improvement Product Knowledge Product Quality Attributes Process Controls Process Parameters Product Specifications Product Design Unit operations, control strategy, etc. Process Design Desired Product Performance Dosage form, stability, formulation, etc. Process Performance Cpk, robustness, etc. Quality by Design

  5. Design Space (ICH Q8) • Definition: The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality • Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. • Design space is proposed by the applicant and is subject to regulatory assessment and approval

  6. Current vs. QbD Approach to Pharmaceutical Development

  7. Pharmaceutical Development & Product Lifecycle Product Design & Development Process Design & Development Manufacturing Development Continuous Improvement ProductApproval Candidate Selection

  8. Pharmaceutical Development & Product Lifecycle Statistical Tool Design of Experiments (DOE) Product Design & Development: Initial Scoping Product Characterization Product Optimization Model Building And Evaluation Process Design & Development:Initial Scoping Process Characterization Process Optimization Process Robustness StatisticalProcess Control Manufacturing Development and Continuous Improvement: Develop Control Systems Scale-up Prediction Tracking and trending

  9. Design of Experiments (DOE) • Structured, organized method for determining the relationship between factors affecting a process and the response of that process • Application of DOEs: • Scope out initial formulation or process design • Optimize product or process • Determine design space, including multivariate relationships

  10. DOE Methodology (2) Conduct randomized experiments (1) Choose experimental design (e.g., full factorial, d-optimal) A B C (3) Analyze data (4) Create multidimensional surface model (for optimization or control) www.minitab.com

  11. Model Building & Evaluation - Examples • Models for process development • Kinetic models – rates of reaction or degradation • Transport models – movement and mixing of mass or heat • Models for manufacturing development • Computational fluid dynamics • Scale-up correlations • Models for process monitoring or control • Chemometric models • Control models • All models require verification through statistical analysis

  12. Model Building & Evaluation - Chemometrics • Chemometrics is the science of relating measurements made on a chemical system or process to the state of the system via application of mathematical or statistical methods (ICS definition) • Aspects of chemometric analysis: • Empirical method • Relates multivariate data to single or multiple responses • Utilizes multiple linear regressions • Applicable to any multivariate data: • Spectroscopic data • Manufacturing data

  13. Quality by Design & Statistics • Statistical analysis has multiple roles in the Quality by Design approach • Statistically designed experiments (DOEs) • Model building & evaluation • Statistical process control • Sampling plans

  14. How can Innoworks assist you? • We can help you every step of the way in implementing Quality- by- Design in your work processes. • Contact us :drshrutibhat@gmail.com

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