Basic understanding on QbD.
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This document discusses Quality by Design (QbD) and Design of Experiments (DoE) principles for drug product development. It aims to develop formulations that reliably deliver the desired pharmacological effects without increasing side effects or losing stability or performance over time. QbD uses a risk-based and knowledge-driven approach to understand critical quality attributes and process parameters that affect product quality. DoE is used to characterize processes and identify sources of variability to ensure consistent manufacturing. The document outlines key ICH guidelines for QbD and DoE and stresses that the goal is achieving a predictable therapeutic response through reproducible, large-scale manufacturing.
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Basic understanding on QbD.
- 1. QbD and DoE’s Basics DR PRASHANT KHEMARIYA
- 2. Objective(s) To achieve a predictable therapeutic response to a drug included in a formulation which is capable of large scale manufacture with reproducible product quality. To turn a drug substance into a viable medicinal product which delivers the drug to the right place at the right time in the right quantity to exert the desired effect, by… Ensuring that the drug product is sufficiently stable that it reproducibly and reliably affects the desired pharmacological response- no loss of activity. no loss of performance. no increase in side effects.
- 3. Understanding about QbD and DoE A Quality System for managing a product's life cycle. Risk and knowledge based decisions. Multifunctional exercise. A regulatory expectation. Systemic approach for products and process thereby decrease patient risk.
- 4. QbD and DoE ICH Q8-Q11 Risk management QTPP (Quality Target Product Profile Critical Attribute Critical Process Parameters Critical Material attribute Analytical control strategy. Process Characterization and continued process verification. Technology transfer Validation protocol, process validation scheme Validation.
- 5. What is out of the box approach ? Common approachOut of the BOX approach
- 6. 10's rule of research Concept Trial Batch Pilot Batch Stability Study Production TIME COST * 1$ * 10 $ * 100 $ * 1,000 $ * 10,000 $ Traditional approach * 10,000 $ Novelization in developmentHigh Low * 100 $ Cost of making changes Ability of implement changes
- 7. Product’s quality during validation Product’s Characteristics Target Upper limit Lower limit Ask yourself which product do you want Which product have poorest quality 1 2 3 4 What is your opinion on product 2 and 3 Confused ? Let me help Costofthequality Got it ? So If I say QUALITY = Compliance With Specification Right or wrong ? Sometimes process increases the cost QUALITY = ON TARGET WITH MINIMUM VARRIATION 1, 2, 3, 4 are products Now What is your opinion on product 2 and 3
- 9. And Finely
- 10. Conclusion The success of bringing a new medicine to the market is the result of a complementary and equally important contribution of scientists working in different scientific fields. As Formulation Development is part of the process of bringing every new drug to the market, the quality of formulation contribution is very critical in the success of new drugs.
- 11. Thanks