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This provides an introduction to Good Manufacturing Practice (GMP) for cosmetic product manufacture and also covers the requirements of ISO 22716. More details can be found on www.cosmetic-gmp.co.uk
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CG Good Manufacturing Practice for Cosmetics
Induction Training
COSMETIC GMP
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© cosmetic-gmp.co.uk COSMETIC GMP
What is GMP?
• Required by European Cosmetic Regulations
– Must comply to sell product in Europe
• It is part of quality management and is a way of working to
make sure that all products are:
– consistently manufactured
– to a quality appropriate for intended use
– the product you have manufactured is fit for purpose
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© cosmetic-gmp.co.uk COSMETIC GMP
What is ‘Fitness for Purpose’?
• Is safe
• Meets / exceeds customer expectation
• Correct product
• Correct material
• Not deteriorated or broken down
• Is in the proper, correctly labelled container
• Is securely sealed
• Free from contamination
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© cosmetic-gmp.co.uk COSMETIC GMP
GMP – What could go wrong?
• Mix up of raw materials, bulk products, packaging & finished
product
• Wrong quantity of ingredients added during making the bulk
• Contamination from people, equipment and the buildings in
which we make cosmetics
• Risk of product deterioration from improper handling and
transfer
• Risk in management of returned products
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© cosmetic-gmp.co.uk COSMETIC GMP
What is Quality & Quality Management?
• Quality – we meet the required specification for product we
make
• Quality Control – we test a small sample of product to tell us
that product meets specification
• Quality Management – systems of working that help us to
make product that is fit for purpose
Good Manufacturing Practice is part of Quality Management
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© cosmetic-gmp.co.uk COSMETIC GMP
Why do we need GMP?
At a company near you…
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© cosmetic-gmp.co.uk COSMETIC GMP
ISO 22716 Guide to GMP for Cosmetics
• Personnel
• Premises
• Equipment
• Raw materials and
packaging
• Production
• Finished product
• Quality control
• Out of specification
product
• Waste
• Subcontract operations
• Deviations
• Complaints & recall
• Change control
• Internal audit
• Documentation
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© cosmetic-gmp.co.uk COSMETIC GMP
1. People
Organisation
Chart & Clear
Responsibilities
Training Program
(Including GMP)
Health &
Hygiene Policy
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© cosmetic-gmp.co.uk COSMETIC GMP
2. Premises
Protect Product
Easy to Clean
Prevent Mix Ups
Floors
Pipe work
Dust & Dirt
Contamination
© Grey World
© Adam Clyde
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© cosmetic-gmp.co.uk COSMETIC GMP
3. Equipment Designed to
Prevent
Contamination
Calibration &
Maintenance
Cleaning &
Sanitisation
© Orange County Archive
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© cosmetic-gmp.co.uk COSMETIC GMP
4. Design & Development
Product &
Process Risk
Assessment
Stability
ProgrammeArt Work
Controls
Risk Based
Challenge
Testing
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© cosmetic-gmp.co.uk COSMETIC GMP
5. Starting Materials
Supplier
Evaluation
Goods Receipt
Process
Supplier
Improvement
Water System
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© cosmetic-gmp.co.uk COSMETIC GMP
6. Production (Manufacture & Pack)
Process Issues &
Improvement
Documentation
Start up & Other
Critical Process
Controls
Bulk & WIP
Storage
© Maria Morri
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© cosmetic-gmp.co.uk COSMETIC GMP
7. Finished Products
Process Issues &
Improvement
Storage &
Release
Procedures
(Validated)
Traceability &
Recall
Returns &
Complaints
Procedure
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© cosmetic-gmp.co.uk COSMETIC GMP
8. Quality Control
Out of Spec &
Improvement
Procedures &
Validated
Methods
Statistically
Based Sampling
Plans
Risk Based
Release Criteria
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© cosmetic-gmp.co.uk COSMETIC GMP
9. Subcontract Operations
Part of YOUR
Quality System
An extension of
your own
organisation
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© cosmetic-gmp.co.uk COSMETIC GMP
10. Improvement
Process Issues
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© cosmetic-gmp.co.uk COSMETIC GMP
Do we comply?
Next Steps…
• Review where your are working…do we comply to ISO 22716
• Report any issues so we can fix these and improve
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© cosmetic-gmp.co.uk COSMETIC GMP
Thank you for using our GMP Training Pack
call us: +44 (0) 800 7720398
email us: [email protected]
COSMETIC GMP