Quality by design

quality by design for formulation and development

1. Quality by Design ( QbD ) For Formulation And Development Presented by:- SUHASINI . V M.Pharm 1 st year (Pharmaceutics)

2. Ref.: ICH Q8 (R2)

3. SIGNIFICANCE OF QbD : Quality by Design means –designing and developing formulations and manufacturing processes to ensure a predefined quality Quality by Design requires – understanding how formulation and manufacturing process variables influence product quality . Quality by Design ensures – Product quality with effective control strategy

4. BENEFITS OF QBD: QbD is good Business Eliminate batch failures Minimize deviations and costly investigations Avoid regulatory compliance problems Organizational learning is an investment in the future QbD is good Science Better development decisions Empowerment of technical staff

5. IMPORTABT OF OBD FOR FORMULATION AND DEVELOPMENT Quality target product profile (QTPP) Critical quality attribute (CQAs) Initial risk assessment for drug substance attributes Initial risk assessment for drug formulation attributes Selection of excipients Excipients compatibility studies Development of Q& Q formula for initial formulation development

6. Design development strategies DOE for optimization of formulation Initial risk assessment for manufacturing process Pilot bioequivalence studies Well defined control strategy Scale up from lab to pilot scale and then commercial scale Container and closure system Development studies to be supported with stability studies

7. Initial risk assessment for drug formulation attributes

8. “A planned set of controls, derived from current product and process understanding that ensures process performance and product quality…..” ICH Q8 (R2) & Q10 Control Strategy includes following elements (but not limited to): Input material attributes (e.g. drug substance, excipients , container closure) Equipment operating conditions In-process controls Finished product specifications Controls for each unit operations Methods and frequency of monitoring and control. Control Strategy

9. Pilot bioequivalence studies A pilot study in a small number of subjects can be carried out before proceeding with a full bioequivalence study. The study can be used to validate analytical methodology, assess variability, optimize sample collection time intervals, and provide other information. Example : Pilot bioequivalence studies can help determine the sampling schedule to assess lag time and dose dumping.

10. Scale up from lab to pilot scale and then commercial scale It is the part of the pharmaceutical industry where a lab scale formula is transformed into a viable product by development of liable practical procedure of manufacturing. Evaluating the results of laboratory studies and making product and process corrections and improvements

11. Container and closure system Suitable container closure system to achieve the target shelf life and to ensure product integrity during shipping primary packaging components & secondary packaging components, if the latter are intended to provide additional protection to the drug product . Packaging aspects must be considered during the development of product . The packaging process parameters may affect the final product quality.

12. Development studies to be supported with stability studies "…… to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity & light, & enables recommended storage conditions, re-test periods & shelf lives to be established” Long Term Intermediate Accelerated

13. Advantages of QbD Benefits for Industry: Better understanding of the process. Less batch failure. More efficient and effective control Return on investment / cost savings. Allows for implementation of new technology to improve manufacturing Improves interaction with FDA –deal on a science level instead of on a process level Allows for continuous improvements in products and manufacturing process.

14. Guidance for Industry: Q8(R2) Pharmaceutical Development Guidance for Industry: Q9 Quality Risk Management Guidance for Industry: Q10 Pharmaceutical Quality System http : // www.drug regulation .org

15. THANK YOU