ICH pharmaceutical development Q8

A brief introduction of ich guideline detailed information on Q8 quality by design

1. Seminar By : Raveena Udhani M.Pharm 1 st Semester Pharmaceutical Quality Assurance Department Guided By:- Dr. Rajesh Parikh Director of Graduate school of Pharmacy Graduate School Of Pharmacy,Gandhinagar

2. Presentation outline Introduction of ICH OBJECTIVE OF ICH ICH LOCATION GOAL OF ICH MEMBERS OF ICH ICH Q8 GUIDLINE INTRODUCTION Q8 annexure Quality by design Example References 2 RAVEENA.UDHANI

3. What is ICH…..? “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceutical for Human use” 3 RAVEENA.UDHANI

4. 4 RAVEENA.UDHANI

5. mission 5 RAVEENA.UDHANI

6. ICH 6 RAVEENA.UDHANI

7. Objectives :- To make recommendation for achieving greater harmonization in the interpretation and application of technical guideline and requirement for product registration. To reduce the need to duplicate the testing carried out during the research and development. To use human animal and material resources economically . To eliminate unnecessary delay in the global development and availability of new medicine. To decrease cost of health care to decrease the cost of cost R&D and to meet the public expectation so that there should be a minimum delay in making safe and efficacious treatment. RAVEENA.UDHANI 7

8. ICH located The ICH secretariat in Geneva, Switzerland. The biennial meetings and conferences of the ICH Steering Committee rotate between the EU, Japan and the USA. 8 RAVEENA.UDHANI

9. Members of ICH ICH is comprised of representatives and research-bases industry in the European Union , Japan USA . In Japan , the members are the Ministry of Health, Labor and Welfare(MHLW) and Japan Pharmaceutical Manufacturers Association(JPMA). In Europe , the members are European Union(EU), and the European Federation of Pharmaceutical Industries and Associations(EFPIA). In USA the members are the Food and Drug Administration(FDA). And the Pharmaceutical Research and Manufactures of America( PhRMA ) . Additional members include Observers from the world Health organization(WHO), European Free Trade Association(EFTA), and Canada. The Observers represent non-ICH Countries and regions. 9 RAVEENA.UDHANI

10. Ich structure 10 RAVEENA.UDHANI

11. ICH structure The ICH structure consists of the ICH stearing Committee ICH Coordinators, Ich Secretariat ICH Working Groups . ICH Steering Committee The Steering Committee is the body that governs the ICH, determines the policies and procedures for ICH, selects topics for harmonization and monitors the progress of harmonization initiatives, each of the ICH parties has two seat on the ICH Steering Committee. ICH Coordinators The Coordinators are fundamental to the smooth running of the ICH and are nominated by each of the parties. An ICH Coordinator acts as the ICH Secretariat. 11 RAVEENA.UDHANI

12. Process of harmonization 12 RAVEENA.UDHANI

13. 13 RAVEENA.UDHANI

14. “Quality” topic : i.e. relating to chemical and pharmaceutical quality Assurance (Stability Testing , Impurity Testing, Etc.) “Efficacy ”Topic: i.e. Those Relating To Clinical studies in human subject(Dose Response Studies, Good Clinical Practices,Ect.) “ Safety”Topic , : i.e., those relating to in vitro and in vivo pre- clinical,studies (Carcinogenicity Testing,Genotoxicity Testing,Etc.) “ Multidisciplinary”topics , i.e., cross-cutting Topics Which do not fit uniquely into one of the above categories. 14 RAVEENA.UDHANI

15. Quality mantra Quality can not be tested in product it has to be built in by design. 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 alternative. 15 RAVEENA.UDHANI

16. Quality 16 RAVEENA.UDHANI

17. safety 17 RAVEENA.UDHANI

18. efficacy 18 RAVEENA.UDHANI

19. multidisciplinary 19 RAVEENA.UDHANI

20. ICHQ8(R2):Pharmaceutical Devlopment Guideline It is emphasized that the quality of a pharmaceutical product should be built in by Design rather than by testing alone. The ICH Q8 guideline describes Good Practices for pharmaceutical product Development. The pharmaceutical industry is one of the most strictly regulated and its products are of excellent quality. Qbd assures the quality of a pharmaceutical product through scientific development and risk management tools and will eventually enable real-time release .regardless of the formulation type. 20 RAVEENA.UDHANI

21. ICH (Q8) Pharmaceutical development 21 RAVEENA.UDHANI

22. 22 RAVEENA.UDHANI

23. Drug substances 23 RAVEENA.UDHANI

24. excipients 24 RAVEENA.UDHANI

25. 25 RAVEENA.UDHANI

26. Formulation development 26 RAVEENA.UDHANI

27. overages 27 RAVEENA.UDHANI

28. Physiochemical & biological properties 28 RAVEENA.UDHANI

29. Container closure system 29 RAVEENA.UDHANI

30. Microbiological attributes 30 RAVEENA.UDHANI

31. compatibility 31 RAVEENA.UDHANI

32. 32 RAVEENA.UDHANI

33. Quality by design 33 RAVEENA.UDHANI

34. Quality by design approach can be used for 34 RAVEENA.UDHANI

35. Why qbd ? 35 RAVEENA.UDHANI

36. Layout of quality by design 36 RAVEENA.UDHANI

37. Target product quality profile 37 RAVEENA.UDHANI

38. Critical quality attributes 38 RAVEENA.UDHANI

39. Material attributes 39 RAVEENA.UDHANI

40. Design space 40 RAVEENA.UDHANI

41. Risk assessment 41 RAVEENA.UDHANI

42. control strategy 42 RAVEENA.UDHANI

43. enhanced development approach 43 RAVEENA.UDHANI

44. Minimal( traditonal )& enhanced development approach 44 RAVEENA.UDHANI

45. Minimal( traditonal )& enhanced devlopment approach 45 RAVEENA.UDHANI

46. What are some barriers to qBD ? 46 RAVEENA.UDHANI

47. process flow: 47 RAVEENA.UDHANI

48. conclusion 48 RAVEENA.UDHANI

49. references 49 RAVEENA.UDHANI

50. 50 RAVEENA.UDHANI