1. GMP system implementation and certification to manufacture seawater ampoules as a dietary supplement under ISO 5 air quality María Pellín Amorós 1

2. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 2

3. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 3

4. Who are we? ● Seawater products – Dietary supplements – Cosmetics – Medical devices 4

5. Who are we? ● Rene Quinton, Biology and Physiology. ● 78 different elements in seawater. 5

6. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 6

7. Advance Quinton Protocol 7

8. ● Salt concentration of the product – 3,3% Hypertonic (only seawater) – 2,1% Hypertonic (seawater + spring water) – 0,9% Isotonic (seawater + spring water) 8

9. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 9

10. GMP dietary supplements If these are dietary supplements, what GMP did you apply? 10

11. GMP dietary supplements http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111 11

12. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 12

13. Application during process ● Raw materials. 13

14. Application during process ● Raw materials. How do we apply the GMP in this case? 14

15. Application during process ● Raw materials. – Transport – Sample – Storage (3-8 ºC) 15

16. Application during process 16

17. Application during process Weigh and mix raw material in 1000L reactor Weigh and mix raw material in 1000L reactor Microfiltration 0,22um Clean water (Bioburden free) 17

18. Application during process Dry hot oven 120ºC 6h 18

19. Application during process Bioburden free water Sterilize vials ISO 5 air quality Sterilize vials Bioburden free water 19

20. Application during process ● Filling process. How do we apply the GMP in this case? 20

21. Application during process ● Annual calibration of the reactor. ● Annual clean room validation. 21

22. Application during process ● Filtration. – Sterilize the filters – Bubble point after manufacture 22

23. Application during process ● Oven validated annually 23

24. Application during process ● Final product validation 24

25. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 25

26. Audit and non-conformities 26

27. Audit and non-conformities 27

28. Index ● Who are we? ● Advance Quinton Protocol ● GMP dietary supplements – Applications during the process ● Audit and non-conformities ● Conclusion 28

29. Conclusion 29

30. Conclusion 30

31. Thanks for your attention María Pellín Amorós mpellin@quinton.es 31