Post on 10-Apr-2020
FPS HEALTH, FOOD CHAIN SAFETY AND ENVIRONMENT
Good Manufacturing Practice for
Cosmetics - Audit
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Els Vrindts
Inspection Service Consumption Products
Federal Public Service for Health, Food Chain Safety
and Environment
Belgium
FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
How to prepare for a GMP audit
Approach to audit of GMP for cosmetics
From materials to finished product
Be prepared – internal check
tips from the field
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Good Manufacturing Practices
Production suitable to ensure the desired quality of
product - Quality assurance
Looking at the whole production process, taking care of
every step
Knowing the critical points
Collecting information and learning
Correcting where necessary
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Good Manufacturing Practices - themes
• Organisation
• People
• Buildings and infrastructure
• Materials
• Procedures
• Documentation
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
Is this site suitable for the type and quantity of
cosmetics produced ?
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
An approach to audit
1. General view of the site • number of people
• Type of products, yearly production
• History of the site(s)
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
An approach to audit
1. General view of the site • Organigram
• Education / qualification of production and
quality control persons
• New worker programs, including hygiene
• continued training of personnel
• Production site & material flows (plan)
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
2. Materials
Ingredients, packaging materials
• Specifications, Quality checks, Certificate of analysis
• Labeling and tracebility of materials
• quarantaine
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
2. Materials
• WATER
• specific quality, treatment, monitoring
• Stock & shipment
• Climate, pest control
• Keeping the quality of stock (closed containers, … )
• stock management
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
3. Quality control - laboratory
• Procedures• Checks of ingredients, packaging, bulk, final product
• > (communication of) release of batches
• Lab equipment, calibration
• Documentation
• Sampling
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
4. Production
Wheighing, mixing, filling
• walls & floors, pest control, material/product flows
• equipment
• procedures
• cleaning, clear line, production, …
• documentation
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
4. Production
Wheighing, mixing, filling
• Tracebility
What if the bulk product looks/smells funny ?
Personnel knows what to do in case of a problem ?
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
Problems & complaints
• Procedures in place for recall
Subcontracting
• specifications !
• Subcontractor : able to meet requirements?
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Approach to GMP audit
Proper treatment of wastes
Return of products > identified, properly stored
Labeling of products
Product Information File
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Be prepared
Self test: is my firm following the GMP?Procedures are in place?
clear and understood?
Instructions are respected?
Internal audit
Ask external view, before official audit
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
Be prepared
Documentation
Records available and up to date?
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
tips
Ingredient specifications, including impurities
! changes in supplier or quality of ingredient
Procedure adapted to site
formula/production methods yield different results in
different sites
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FPS HEALTH, FOOD CHAIN SAFETY and ENVIRONMENT
tips
Quality control adapted to product and consumer
profile
! hospitals, health care > consumers with lower
immune defense; adapted testing of microbial
quality
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