Presentation on Quality by Design<br />‘Pharmaceutical GMPs <br />  for the 21st  Century’ <br />By: Akhilesh Kumar Dwived...
QUALITY BY DESIGN<br />processes<br />products<br />
HISTORY: <br />Quality by Design (QbD) is a concept first outlined by well-known quality expert Joseph M. Juran in various...
What is Quality?<br />Quality<br />Requirements<br />= need or   expectations<br />Target Product<br />Quality Profile<br ...
The quality mantra<br />   “Quality can not be tested into  products; it has to be built in  by design”<br />“Quality is n...
How can we modernize our industry?<br />More knowledge of our products and processes, allowing better design and more cont...
The knowledge pyramid<br />Desired State<br />Knowledge based decisions<br />First<br />Principles <br />Why?<br />MECHANI...
The New Quality Paradigm – The Evolving Regulatory Framework<br />Product Life Cycle<br />Product<br />Design<br />       ...
Definition: Quality by Design<br />Quality by Design is<br />a systematic approach to development<br />that begins with pr...
Quality by Design approach can be used for<br /><ul><li>Simple dosage forms
Advanced drug delivery systems
Devices
Combination products
Active pharmaceutical ingredients
Materials incl excipients
Analytics</li></li></ul><li>Impact of QbD<br /><ul><li>Companies re-organize their science
Universities change their curriculum
Health authorities change their assessment and inspection</li></li></ul><li>QUALITY BY DESIGN<br />Step 1. Agree on the Ta...
What are the steps in aQuality by Design approach?<br />2. CRITICAL <br />QUALITY <br />ATTRIBUTES<br />3. LINK <br />MAs ...
Step 1. Agree on the Target Product Profile<br />Consider:<br />dosage form<br />route of administration<br />strength<br ...
CRITICAL QUALITY ATTRIBUTES - definition<br />A critical quality attribute (CQA) is a - physical, chemical, biological, or...
Step 4. Define the Design Space<br /><ul><li>The linkage between - the process inputs (input variables and process       p...
can be described in the design space.</li></li></ul><li>
Definition of Design Space<br />Roll pressure<br />Gap width<br />Screen Size<br /><ul><li>The material attributes and pro...
The multidimensionalcombination and interaction of input variables (e.g. material attributes) and process parameters that ...
Step 5. Define the Control Strategy<br />The control strategy should describe and justify how<br /><ul><li>in-process cont...
the controls of        - input materials          (drug substance and excipients),        - container closure system,     ...
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Qb D Akhilesh Dwivedi

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Quality by Design

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Qb D Akhilesh Dwivedi

  1. 1. Presentation on Quality by Design<br />‘Pharmaceutical GMPs <br /> for the 21st Century’ <br />By: Akhilesh Kumar Dwivedi<br />Dr. Reddy’s Labs. F.T.O-III<br />Date: 18 Jan 2011<br />QUALITY BY DESIGN<br />
  2. 2. QUALITY BY DESIGN<br />processes<br />products<br />
  3. 3. HISTORY: <br />Quality by Design (QbD) is a concept first outlined by well-known quality expert Joseph M. Juran in various publications, most notably Juran on Quality by Design. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned in the first place.<br />QUALITY BY DESIGN<br />
  4. 4. What is Quality?<br />Quality<br />Requirements<br />= need or expectations<br />Target Product<br />Quality Profile<br /> Patient<br />(or surrogate)<br />“Good pharmaceutical quality represents <br />an acceptably low risk of failing to achieve <br />the desired clinical attributes.”<br />
  5. 5. The quality mantra<br /> “Quality can not be tested into products; it has to be built in by design”<br />“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.” <br />
  6. 6. How can we modernize our industry?<br />More knowledge of our products and processes, allowing better design and more control<br />Better management:- introduction of quality risk management- expansion of GMP to more extensive pharmaceutical quality system<br />
  7. 7. The knowledge pyramid<br />Desired State<br />Knowledge based decisions<br />First<br />Principles <br />Why?<br />MECHANISTIC<br />KNOWLEDGE<br />How?<br />“CAUSAL" KNOWLEDGE<br />What “Causes” What?<br />Need for regulatory oversight<br />CORRELATIVE KNOWLEDGE<br />What Is Correlated to What?<br />Current State<br />DESCRIPTIVE KNOWLEDGE: <br />What?<br />
  8. 8. The New Quality Paradigm – The Evolving Regulatory Framework<br />Product Life Cycle<br />Product<br />Design<br /> Process<br /> Design<br />Scale-up &<br />Transfer<br /> Commercial<br /> Manufacture<br />Product<br />ICH Q8/Q8(R) - Pharmaceutical Development<br />PAT Guidance<br />ICH Q9 – Quality Risk Management<br />ICH Q10 – Pharmaceutical Quality Systems<br />
  9. 9. Definition: Quality by Design<br />Quality by Design is<br />a systematic approach to development<br />that begins with predefined objectives<br />and emphasizes - product and process understanding - and process control,<br />based on sound science and quality risk management.<br />
  10. 10. Quality by Design approach can be used for<br /><ul><li>Simple dosage forms
  11. 11. Advanced drug delivery systems
  12. 12. Devices
  13. 13. Combination products
  14. 14. Active pharmaceutical ingredients
  15. 15. Materials incl excipients
  16. 16. Analytics</li></li></ul><li>Impact of QbD<br /><ul><li>Companies re-organize their science
  17. 17. Universities change their curriculum
  18. 18. Health authorities change their assessment and inspection</li></li></ul><li>QUALITY BY DESIGN<br />Step 1. Agree on the Target Product Profile<br />Step 2. Determine the Critical Quality Attributes (CQAs)<br />Step 3. Link the drug and excipient attributes and the process parameters to the CQAs<br />Step 4. Define the Design Space<br />Step 5. Define the Control Strategy<br />Step 6. Prepare QbD registration file<br />Step 7. Product lifecycle management and continual improvement<br />
  19. 19. What are the steps in aQuality by Design approach?<br />2. CRITICAL <br />QUALITY <br />ATTRIBUTES<br />3. LINK <br />MAs AND PPs <br />TO CQAS<br />1. TARGET<br />PRODUCT <br />PROFILE<br />4. ESTABLISH<br />DESIGN <br />SPACE<br />6. PRODUCT <br />LIFECYCLE <br />MNGMNT<br />5. ESTABLISH<br />CONTROL <br />STRATEGY<br />
  20. 20. Step 1. Agree on the Target Product Profile<br />Consider:<br />dosage form<br />route of administration<br />strength<br />release / delivery of the drug<br />pharmacokinetic characteristics(e.g., dissolution; aerodynamic performance)<br />drug product quality criteria(e.g., sterility, purity).<br />Target Product Profile:- a prospective and dynamic summary of the quality characteristics of a drug product - that ideally will be achieved to ensure that the desired quality, and hence the safety and efficacy, of a drug product is realized. <br />The TPP forms the basis of design of the product.<br />
  21. 21.
  22. 22. CRITICAL QUALITY ATTRIBUTES - definition<br />A critical quality attribute (CQA) is a - physical, chemical, biological, or microbiological property or characteristic - that should be within an appropriate limit, range, or distribution - to ensure the desired product quality.<br />
  23. 23.
  24. 24.
  25. 25.
  26. 26.
  27. 27.
  28. 28.
  29. 29. Step 4. Define the Design Space<br /><ul><li>The linkage between - the process inputs (input variables and process parameters) and - the critical quality attributes
  30. 30. can be described in the design space.</li></li></ul><li>
  31. 31. Definition of Design Space<br />Roll pressure<br />Gap width<br />Screen Size<br /><ul><li>The material attributes and process parameters that assure quality.
  32. 32. The multidimensionalcombination and interaction of input variables (e.g. material attributes) and process parameters that have beendemonstrated to provide assurance of quality. </li></li></ul><li>
  33. 33.
  34. 34. Step 5. Define the Control Strategy<br />The control strategy should describe and justify how<br /><ul><li>in-process controls and
  35. 35. the controls of - input materials (drug substance and excipients), - container closure system, - intermediates and
  36. 36. the controls of end products </li></ul>contribute to the final product quality<br />
  37. 37. 5. CONTROL STRATEGY<br />Elements of a control strategy can include, but are not limited to, the following:<br />• Control of input material attributes (e.g., drug substance, adhesive polymer, primary packaging materials) based on an understanding of their impact on processability or product quality<br />• Product specification(s)<br />• Controls for unit operations that have an impact on downstream processing or end-product quality (e.g., the impact of solvent on degradation)<br />• In-process or real-time release in lieu of end-product testing<br />• A monitoring program (e.g., full product testing at regular intervals) for verifying multivariate prediction models.<br />
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