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GMP system implementation and certification to manufacture seawater ampoules as a dietary supplement under ISO 5 air quality María Pellín Amorós. Index. Who are we ? Advance Quinton Protocol GMP dietary supplements Applications during the process Audit and non- conformities

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Index

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  1. GMP systemimplementation and certificationto manufacture seawaterampoules as a dietarysupplementunder ISO 5 air quality María Pellín Amorós

  2. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  3. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  4. Whoare we? • Seawaterproducts • Dietarysupplements • Cosmetics • Medical devices

  5. Whoare we? • Rene Quinton, Biology and Physiology. • 78 differentelements in seawater.

  6. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  7. Advance Quinton Protocol

  8. Advance Quinton Protocol • Salt concentration of theproduct • 3,3% Hypertonic (onlyseawater) • 2,1% Hypertonic (seawater + springwater) • 0,9% Isotonic (seawater + springwater)

  9. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  10. GMP dietarysupplements Ifthese are dietarysupplements, what GMP didyouapply?

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

  12. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  13. Applicationduringprocess • Rawmaterials.

  14. Applicationduringprocess • Rawmaterials. How do weapplythe GMP in this case?

  15. Applicationduringprocess • Rawmaterials. • Transport • Sample • Storage (3-8 ºC)

  16. Applicationduringprocess

  17. Applicationduringprocess Weigh and mix raw material in 1000L reactor Cleanwater (Bioburden free) Microfiltration 0,22um

  18. Applicationduringprocess Dryhot oven 120ºC 6h

  19. Applicationduringprocess Bioburden free water ISO 5 air Bioburden free water ISO 5 air quality Sterilizevials Sterilizevials

  20. Applicationduringprocess • Fillingprocess. How do weapplythe GMP in this case?

  21. Applicationduringprocess • Annualcalibration of the reactor. • Annualcleanroomvalidation.

  22. Applicationduringprocess • Filtration. • Sterilizethefilters • Bubblepointafter manufacture

  23. Applicationduringprocess • Oven validatedannually

  24. Applicationduringprocess • Finalproduct validation

  25. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  26. Audit and non-conformities

  27. Audit and non-conformities

  28. Index Whoare we? Advance Quinton Protocol GMP dietarysupplements Applicationsduringtheprocess Audit and non-conformities Conclusion

  29. Conclusion GMP Whatisnotwrittenisnotfact SOP’s RecordsTraining

  30. Conclusion

  31. Thanksforyourattention María Pellín Amorós mpellin@quinton.es

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