QUALITY BY DESIGN

The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.

1. Present By- Manpreet Ghai Tanaya Palit M.Pharm (Pharmaceutics) 2 nd sem

2. Content Quality quality by design How can we achieve Quality by Design ? What is ICH Q8 ? Objective of ICH guidelines Pharmaceutical Development Q8 Examples of QbD Approaches Regulatory Agency and Industry views on QbD Conclusion Reference

3. What is Quality ?

4. Quality by Design

5. Means Designing and developing formulations and manufacturing process to ensure a predefined quality Requires Understanding how formulations and manufacturing process variables influence product quality Ensure Product quality with effective control strategy So.. What is the quality design ?

6. How can we achieve Q uality by Design ?

7. What is ICH Q8 ? Guidelines for the descriptions what is in P2 Describe the minimal standard for P2 Opens door to get closer to the “ Described State ” - Science based - Includes risk management - Continuous improvement - Real Times Release

8. Objective of ICH guidelines to review and study ICH guidelines Q8 to understand the concept of ICH guidelines Q8 to know the importance and study the benefits of ICH guidelines Q8

9. Pharmaceutical Development Q8 Describes science and risk-based approaches for pharmaceutical product and manufacturing process development. Introduced concepts of design space and flexible regulatory approaches. introduced concept of Quality by Design ( QbD ) and provided examples of QbD development approaches and design space.

10. Examples of QbD Approaches Quality Target Product Profile (QTPP) Determine ‘potential’ critical quality attributes (CQAs) Link raw material attributes and process parameters CQAs and perform risk assessment. D evelopment a design space (Optional and no required). Design and implement a control strategy. Manage product lifecycle.

11. Regulatory Agency and Industry views on QbD Industry Regulatory Agency Integrate across business units(e.g. R&D, manufacturing quality) Integrate review inspection and compliance Integration across disciplines (e.g. chemist,engineer,statisticians) Incorporate multidisciplinary CMC review(e.g. chemist,engineer,statisticians) Incorporate quality system to manage the new approach Implement Quality Management system

12. C onclusion Why we use quality by Design ? Provides a proactive approaches to product development potential to reduce queries and review time to quickly get to the root cause and resolution of any deviations. Allows for continues improvements in product and manufacturing. Allows for better understanding how APIs and excipients affects manufacturing. increase manufacturing efficiency , reduce cost and waste

13. Reference Computer-aided applications in pharmaceutical technology, published by Woodhead publishing Limited,2013,Quality-by-design in pharmaceutical development, page no. 1-15 World Journal of Pharmaceutical Research ,volume 2, Issue 5,1409-1422, ISSN 2277-7105,Quality by Design-Novelty In Pharmaceuticals,Shajeeya,Amren.SK *, ViswanathA.Srinivasa Babu P.