ISO 22716 Cosmetic Good Manufacturing Practices, ISO 22716 requirements, ISO 22716 GMP understanding
ISO 22716 requirements are focussed towards implementing Good Manufacturing Practices in cosmetic industries.
Every Cosmetic Product circulating onto the European Market will have to be produced according to the Good Manufacturing Practices. This applies to goods processed in the EU-27 countries as well as for all imported cosmetics.
Other requirements include an increased responsibility of producers and distributors, particularly regarding ingredients toxicity, product labelling, a more comprehensive product file and compulsory notification of new product introduction to the European Commission.
Some of the requirements of the ISO 22716: 2007 standard are
1 Scope
2 Terms and Definition
3. Personnel
3.2 Key Responsibilities
3.3.1 Management Responsibilities
3.4 Training
3.4.1 Training and Skills
3.5 Personnel Hygiene and Health
3.6 Visitors and untrained personnel
4 Premises
4.1 Principle
4.2 Types of Area
4.3 Space
4.4 Flow
4.5 Floors, Walls, Ceilings, Windows
4.6 Washing and Toilet facilities
4.7 Lighting
4.8 Ventilation
4.9 Pipe work drains and ducts
4.10 Cleaning and sanitization
4.11 Maintenance
4.12 Consumables
4.13 Pest Control
5 Equipment
5.2 Equipment Design
5.3 Installation
5.4 Calibration
5.5 Cleaning and Sanitization
5.6 Maintenance
5.7 Consumables
5.8 Authorizations
5.9 Back up systems
6 Raw Materials and packaging materials
6.1 The guiding principle
6.2 Purchasing
6.3 Critical and Non-critical raw material
7 Production
7.1 Guiding Principle
7.2 Manufacturing Operations
7.2.1 Availability of relevant document
7.2.2 Startup Checks
7.2.3 Assignment of a batch number
7.2.4 Identification and in process Operations
7.2.5 In process Controls
7.2.6 Bulk Product Storage
7.2.7 Restocking and Raw Materials
7.3 Packaging Operations
7.3.1 Availability of relevant documents
7.3.2 Startup checks
7.3.3 Assignment of Batch number
7.3.4 Packing Line Identification
7.3.5 Checks of on line Control Equipment
7.3.6 In-process
7.3.7 Re-stocking of packaging materials
7.3.8 Identifications
8 Finished products
8.1 Guiding Principle
8.2 Release
8.3 Storage
8.4 Shipment
8.5 Returns
9 Quality Control calibrations
9.1 Guiding Principle
9.2 Test Methods
9.3 Acceptance Criteria
9.4 Results
9.5 Out of specification results
9.6 Reagents, solutions, reference standards, culture, media
9.7 Sampling
9.8 Retain Sample
10 Treatment of product that is out of specification
10.1 Rejected finished products, bulk products, raw materials and packaging
11 Waste Management
11.1 Guiding Principle
11.2 Types of waste
11.3 Food
11.4 Containers
11.5 Disposal
12 Sub contracting
12.2 Types of Subcontract
Manufacturing
Packaging
Analysis
Equipment
Pest Control
12.3 Contract given
12.4 Contract Acceptor
12.5 Written contract agreement
13 Handling of Deviations
14 Complaints and Recalls
14.2 Product complaints
14.3 Product recalls
15 Change Control
16 Internal Audit
17 Documentation
17.2 Types of document
Procedures—Instructions, specifications, protocols, reports
Other countries where the Cosmetics Market is well developed are also on the way to implement Good Manufacturing Practices as a compulsory requirement to enter their market.
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