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This presentation talks about the cosmetics good manufacturing practice (GMP) and standard ISO 22716, which cosmetic manufacturers have to follow if they want to put their products on the EU market.
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COSMETIC GOOD MANUFACTURING
PRACTICE – ISO 22716EU REGULATION 1223/2009
& ISO 22716
© CE.way Regulatory Consultants Ltd
© CE.way Regulatory Consultants Ltd
LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing directive 76/768/EC)
• Applicable: July 2013 onwards
© CE.way Regulatory Consultants Ltd
COSMETIC GMP – ISO 22716
• One of the pillars of the EU cosmetics Regulation • To ensure their safety, cosmetic products placed on the
EU market should be produced according to good manufacturing practice (GMP)
• Compliance with GMP is presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union ISO 22716:2007
© CE.way Regulatory Consultants Ltd
COSMETIC GMP – ISO 22716
• ISO 22716 also has direct links to many other cosmetic regulations in place around the world Regulators in several countries and regions have adopted this
standard• ISO 22716 gives guidance for the production, control, storage
and shipment of cosmetic products. It deals with all aspects of the supply chain of cosmetic products
• It covers the quality aspects of the products, but it does not cover: Safety aspects for the personnel engaged in the plant Protection of the environment Not applicable to research and development activities
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COSMETIC GMP – ISO 22716
ISO 22716 provides guidance in a number of areas, which can be broadly divided into 5 categories:• Personnel• Premises and equipment• Production• Quality control• Quality systems
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ISO 22716 – PERSONNEL
• Organization• Key responsibilities• Training• Hygiene
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ISO 22716 – PREMISES AND EQUIPMENT
• Proper design• Cleaning and sanitization• Maintenance• Calibration
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ISO 22716 – PRODUCTION
Materials management
Manufacturing operations
Packaging operationsStorage
Shipment
• Purchasing• Receipt• Identificati
on and status
• Release• Storage• Re-
evaluation
• Documentation• Start-up checks• In-process
controls• Storage• Shipment• Returns
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ISO 22716 – QUALITY CONTROLS
• Sampling• Specifications• Testing• Out of specification investigation• Release
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ISO 22716 – QUALITY SYSTEMS
Documentation control
Deviations
Complaints & recallsInternal audit
Change control
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