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.

1. EU REGULATION 1223/2009
& ISO 22716
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2. LEGISLATION
• EU cosmetic regulation 1223/2009 (replacing
directive 76/768/EC)
• Applicable: July 2013 onwards
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3. 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
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4. 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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5. 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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6. ISO 22716 – PERSONNEL
• Organization
• Key responsibilities
• Training
• Hygiene
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7. ISO 22716 – PREMISES AND EQUIPMENT
• Proper design
• Cleaning and sanitization
• Maintenance
• Calibration
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8. ISO 22716 – PRODUCTION
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Materials
management
Manufacturing
operations
Packaging
operations
Storage
Shipment
• Purchasing
• Receipt
• Identificati
on and
status
• Release
• Storage
• Re-
evaluation
• Documentation
• Start-up checks
• In-process
controls
• Storage
• Shipment
• Returns

9. ISO 22716 – QUALITY CONTROLS
• Sampling
• Specifications
• Testing
• Out of specification
investigation
• Release
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10. ISO 22716 – QUALITY SYSTEMS
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Documentation
control
Deviations
Complaints &
recalls
Internal audit
Change control

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info@ceway.eu
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