GMP system implementation and certification to manufacture

seawater ampoules as a dietary supplement under ISO 5 air quality

María Pellín Amorós 1

Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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Who are we?

● Seawater products

–Dietary supplements

–Cosmetics

–Medical devices

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Who are we?

● Rene Quinton, Biology and Physiology.● 78 different elements in seawater.

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Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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Advance Quinton Protocol

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Advance Quinton Protocol

● Salt concentration of the product

– 3,3% Hypertonic (only seawater)

– 2,1% Hypertonic (seawater + spring water)

– 0,9% Isotonic (seawater + spring water)

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Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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GMP dietary supplements

If these are dietary

supplements, what GMP did

you apply?

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GMP dietary supplements

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

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Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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Application during process● Raw materials.

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Application during process● Raw materials.

How do we apply the GMP in this case?

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Application during process

● Raw materials.

– Transport

– Sample

– Storage (3-8 ºC)

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Application during process

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Application during process

Weigh and mix raw material in1000L reactor

Microfiltration 0,22um

Clean water

(Bioburden free)

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Application during process

Dry hot oven 120ºC 6h

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Application during process

Bioburden free water

Sterilize vials

ISO 5 air quality

ISO 5 air

Sterilize vials

Bioburden free water

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Application during process● Filling process.

How do we apply the GMP in this case?

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Application during process● Annual calibration of the

reactor.

● Annual clean room validation.

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Application during process● Filtration.

– Sterilize the filters– Bubble point after

manufacture

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Application during process● Oven validated annually

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Application during process● Final product

validation

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Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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Audit and non-conformities

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Audit and non-conformities

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Index● Who are we?● Advance Quinton Protocol● GMP dietary supplements

–Applications during the process

● Audit and non-conformities● Conclusion

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Conclusion

GMP

What is not written is not fact

SOP’s Records Training

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Conclusion

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Thanks for your attention

María Pellín Amorós

mpellin@quinton.es

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