Regulatory and industrial view on Quality by design ..CADD

Aspect which concerned with regulatory bodies and industry.some rules and guidelines which is followed by Qbd

1. CHHATRAPATI SHAHUJ I MAHARAJ UNIVERSITY, KANPUR SCHOOL OF PHARMACEUTICALUNIVERSITY PRESENTATION ON REGULATORY AND INDUSTRY VIEWS ON QbD PRESENTED BY RIYA GUPTA M. PHARM 2 nd sem.(Pharmaceutics)

2. INTRODUCTION REGULATORY VIEWS ON QbD QbD FACILITIES INDUSTRY VIEWS ON QbD QbD INDUSTRY AND REGULATORY BODIES 13 CONTENT:

3. Introduction The pharmaceutical quantity by design is a systemic approach to development that begins with predefined objectives and emphasizes product and process understanding and process, control based on sound science and quantity risk management. F QbD has been adopted by U.S. FDA. For the discovery, development and manufacturing of drugs. According to ICH Q8 (R1) QbD is Defined as: A Systemic approach to development that begins with predefined objectives. Aim of QbD : Design a quality product quality of mfg. process product should meet patients need product development may very between products 3

4. Regulatory views on QbD: As defined by an FDA official “ The QbD concept represents product and process performance characteristics scientifically designed to meet specific objectives not merely empirically derived from performance of test batches . QbD facilities: Innovation Increase manufacturing efficiency Reduce cost/projects cost Minimize/ eliminate potential compliance actions Enhance opportunities for first cycle approval Streamline post approval changes and regulatory process Enable more focused inspection

5. Industry views on QbD: 5 Pfizer was one of the first companies to implement QbD and PAT concept. Trough these concepts the company gained enhanced process understanding higher process capability better product quality and increased flexibility to implement continuous improvement changes. Industry Regulatory agency Development of scientific understanding of critical process and product process Scientifically based assessment of product and manufacturing process design and development. Controls and testing are designed based on limit of scientific understanding are development stage Evaluation and approval of product quality specification in light to established standards purity, stability, content uniformity Utilization of knowledge gained over the products lifecycle for continuous improvement Evaluation of post approval changes based on risk and science.

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