Quality by-design-(-qbd)-converted

Quality by Design ppt

1. 1 Presented by- Vijay verma M.Pharm 2 nd Semester Roll No. 8561013 University Institute Of Pharmacy Quality by Design

2. Introduction to Quality Quality by Design (QbD) Significance of Quality by Design QbD frame (in ICH docs) Use of QbD approach Target product quality profile Critical quality attributes Material attributes Process parameter Design space & determination C ontrol strategy Risk assessment Importance of QbD for Formulation and Development Conclusion References Content 2

3. The suitability of either a drug substance or a drug product for its intended use. The term include such attributes as the identity, strength & purity It also refer to product free of contamination and reproducibly delivers the therapeutic benefit promised in the label to consumer Quality 3

4. A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on science and quality risk management Quality by Design is emerging to enhance the assurance of safe, effective drug supply to consumer and also offer promise to significantly improve manufacturing quality performance. Quality by Design 4

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17. Quality target product profile Critical quality attributes Initial risk assessment for drug formulation Selection of Excipients Excipients compatibility studies Development of formula for initial formulation development Design development strategies Scale up from lab to pilot scale and then commercial scale Importance of QbD for Formulation and Development 17

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