Quality by Design.pptx

The Pharmaceutical Quality by Design 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.

Quality cannot be tested into products; it has to be built in by design.

1. QUALITY BY DESIGN NAME : BHUMIN N. JAIN M. PHARM FIRST YEAR DEPARTMENT OF PHARMACEUTICS GUIDED BY – DR. H. S. MAHAJAN SIR 1

2. CONTENTS : Introduction Definition Objectives Advantages ICH guidelines Elements of QbD QbD Tools Applications Conclusion 2

3. INTRODUCTION : Quality: “Quality cannot be tested into products; it has to be built in by design” Quality by design is a concept first outlined by Joseph M. Juran . 3

4. Definition : The Pharmaceutical Quality by Design 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. 4

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6. OBJECTIVES OF PHARMACEUTICAL QbD: To achieve meaningful product quality specifications that are based on clinical performances. To increase process capability and reduce product variability. To increase product development and manufacturing efficiencies. To enhance root cause analysis and post approval change management. To prevent regulatory compliance issues. Increase the efficiency of production, lower costs, avoid waste. 6

7. ADVANTAGES OF QBD: Benefits for Industry: Better understanding of the process Less batch failure More efficient and effective control of change Return on investment or cost savings 7

8. ADVANTAGES OF QBD: Additional opportunities: Reduction of post-approval submissions More efficient technology transfer to manufacturing Risk-based approach and identification Innovative process validation approaches 8

9. ICH Guidelines : Q8: Pharmaceutical Development Q9: Quality Risk Management Q10: Pharmaceutical Quality System 9

10. Elements of QbD: 10

11. 1. QUALITY TARGET PRODUCT PROFILE (QTPP) QTPP is defined as quality that ideally will be achieved to ensure that the desired quality,safety and efficacy of drug product. Considerations for inclusion in QTPP could include the following: Dosage form Route of administration Pharmacokinetic characteristics Strength Release rate 11

12. 2. CRITICAL QUALITY ATTRIBUTE (CQA) CQA is defined as a physical,chemical,biological or microbiological property that should be with in an appropriate limit or range to ensure the desired product quality. CQAs are generally- Drug substance Excipients Intermediates Drug product 12

13. 3.CRITICAL PROCESS PARAMETER (CPP) A process parameter whose variability has an impact on CQA and therefore should be monitor or controlled to ensure process produces the desired quality. CPPs have a direct impact on CQAs. Process parameter can be measured and controlled. Examples of CPP- temperature, cooling rate, rotation speed, pH. 13

14. 4. Quality Risk Management (QRM) As per the ICH Q9 Guidelines, QRM provides a structure to start and follow a risk management process. QRM is a systematic process for assessment, control, communicate and review the risk related to the quality of drug product. Principle of QRM: The evaluation of risk to quality should be based on scientific knowledge and link to protection of the patient. 14

15. 5. DESIGN SPACE As per ICH Q8 Guidelines, aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of product. It is a multidimensional combination and interaction of input variables and process parameter established to provide quality assurance. Design space is proposed by applicant and is subjected to regulatory assessment and approval. 15

16. 6. CONTROL STRATEGY As per ICH Q10 Guidelines, it is a management system to direct and control a pharmaceutical company with regard to quality. A control strategy is designed to ensure that a product of required quality will be produced consistently. The elements of control which contribute to final product quality include In process controls Control of input materials eg. Excipient and drug substance Container closure system 16

17. QUALITY BY DESIGN TOOLS 17

18. 1. DESIGN OF EXPERIMENTS (DOE) DOE is structured ,organized method for determining relationship between factors affecting a process and the response of that process. DOE is effective in design of different dosage forms and unit operations. Guarantee high research efficiency and improved product quality. The DOE also reveals between input factors and output responses. 18

19. DOE METHODOLOGY 19

20. A series of structured tests are designed in which planned changes are made to the input variables of a process or system The effect of these changes on a predefined output are then assessed. DOE is important as a formal way of maximizing information gained and minimizing resources required. 20

21. 2.RISK ASSESSMENT Risk: Risk is defined as the combination of the probability of occurrence of form and severity of that form. Risk assessment : A systematic process of organizing information to support a risk decision to be made with in risk management process. It consists of identification of hazards analysis and evaluation of risk associated with those hazards. 21

22. 3. PROCESS ANALYTICAL TECHNOLOGY (PAT) A system for designing, analysing, and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and in process materials and process with goal of ensuring final product quality. 22

23. APPLICATIONS OF QUALITY BY DESIGN (QBD) In pharmaceutical development. To design a quality product and a manufacturing process to consistently deliver the intended performance of product. In life cycle management. 23

24. CONCLUSION- QbD is increasingly becoming an important and widely used technique in pharmaceutical product development. Implementing QbD concept in product development provide quality medicines to patients, and production improvements to manufacturers with reduced batch failures and drug regulatory bodies will have greater confidence in robust quality of product. As such QbD is becoming a promising scientific tool in quality assurance in pharmaceutical industry. 24

25. References- 1. Woodcock J. The Concept of Pharmaceutical Quality. 7th ed. American Pharmaceutical Review; 2004. (6), 1010-1015. 2. Nadpara NP, Thumar RV, Kalola VN, Patel PB. Quality by design (QBD): A complete review. Int J Pharm Sci Rev Res. 2012;17(2):20-8. 3. Juran JM, Godfrey AB. Juran's Quality Handbook. 5th ed. McGraw Hill; 1998, 29.1 4. Zhang L, Mao S. Application of quality by design in the current drug development. Asian journal of pharmaceutical sciences. 2017 Jan 1;12(1):1-8. 5. Kadam VR, Patil MP, Pawar VV, Kshirsagar S. A review on: Quality by design (QbD). Asian J. Res. Pharm. Sci. 2017 Dec 24;7(4):197-204. 25

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