Introduction to ISO 22716

ISO 22716 is an international standard that defines Good Manufacturing Practices (GMP) for cosmetic products.
This standard provides guidelines to ensure the quality and safety of cosmetics throughout the entire manufacturing process -- from raw material procurement to the final product shipment.
ISO 22716 is a globally recognized GMP standard in the cosmetics industry and is recommended for compliance by various regulatory authorities, including the EU (EU GMP), the United States (FDA), and Japan (J-GMP).
The standard is applicable to cosmetic manufacturers as well as related supply chain entities, including raw material suppliers, packaging and distribution providers. It can also be integrated with other management systems such as ISO 9001 (Quality Management System) and ISO 22000 (Food Safety Management System).

Benefits of ISO 22716

Organizations implementing ISO 22716 can expect the following benefits:

Assurance of Cosmetic Product Quality and Safety
● Strengthens quality and hygiene management across all stages: raw materials, manufacturing, packaging, storage, and distribution
● Prevents product contamination and quality degradation

Compliance with International Cosmetic Regulations
● Aligns with GMP requirements of the EU, FDA (USA), MHLW (Japan), and NMPA (China)
● Fulfills essential regulatory requirements for global market access

Enhanced Consumer Trust and Brand Value
● Ensures safe product supply, increasing customer satisfaction and brand credibility
● Minimizes the likelihood of product recalls and quality-related issues

Establishment of Risk Prevention and Management Systems
● Prevents contamination and cross-contamination in the manufacturing environment
● Supports risk assessment and management processes related to product safety

Improved Process Efficiency and Cost Reduction
● Enhances production efficiency through standardized operating procedures
● Reduces defect rates and rework costs

Scope of Application for ISO 22716

This standard can be applied across the entire cosmetics manufacturing and supply chain, including:
● Cosmetic manufacturers (e.g., skincare, makeup, hair care, personal care products)
● Suppliers of cosmetic ingredients (e.g., functional ingredients, fragrances, preservatives)
● Packaging and container manufacturers
● Cosmetic distribution and logistics providers (e.g., wholesalers, retailers, e-commerce)
● ODM and OEM manufacturers (outsourced production partners)

Summary of Key Features of ISO 22716

● Ensures safety and quality across cosmetic manufacturing processes
● Enables compliance with internationally recognized GMP standards
● Addresses regulatory requirements of authorities such as the EU, FDA, and J-GMP
● Can be integrated with HACCP and ISO 9001 systems
● Serves as a critical certification for entry into global cosmetic markets

Table of Requirements - ISO 22716:2007 (Cosmetic GMP)

3. Personnel

3.1 Principles

3.2 Organization

3.3 Key Responsibilities

3.4 Training

3.5 Employee Hygiene and Health

3.6 Visitors and Untrained Personnel

4. Premises

4.1 Principles

4.2 Layout of Areas

4.3 Space

4.4 Flow (of materials, personnel, products)

4.5 Floors, Walls, Ceilings, and Windows

4.6 Washing and Sanitary Facilities

4.7 Lighting

4.8 Ventilation

4.9 Piping, Drainage, and Ducts

4.10 Cleaning and Sanitation

4.11 Maintenance

4.12 Consumables

4.13 Pest Control

5. Equipment

5.1 Principles

5.2 Design of Equipment

5.3 Installation

5.4 Calibration

5.5 Cleaning and Sanitation

5.6 Maintenance

5.7 Consumables

5.8 Authorization

5.9 Backup Systems

6. Raw Materials and Packaging Materials

6.1 Principles

6.2 Purchasing

6.3 Receipt

6.4 Checking and Status

6.5 Release

6.6 Storage

6.7 Re-evaluation

6.8 Quality of Water Used in Production

7. Production

7.1 Principles

7.2 Manufacturing Operations

7.3 Packaging Operations

8. Finished Products

8.1 Principles

8.2 Release

8.3 Storage

8.4 Shipment

8.5 Product Recall and Return

9. Quality Control

9.1 Principles

9.2 Testing Methods

9.3 Acceptance Criteria

9.4 Results

9.5 Out-of-Specification Results

9.6 Reagents, Solutions, Standards, and Culture Media

9.7 Sampling

9.8 Retained Samples

10. Handling of Deviated Products

10.1 Nonconforming Products, Finished Goods, Bulk Products, Raw Materials, and Packaging Materials

10.2 Reworked Finished Goods and Bulk Products

11. Waste

11.1 Principles

11.2 Types of Waste

11.3 Flow

11.4 Containers

11.5 Disposal

12. Subcontracting

12.1 Principles

12.2 Types of Subcontracting

12.3 Contract Giver

12.4 Contract Acceptor

12.5 Contract

13. Deviations

14. Complaints and Recalls

14.1 Principles

14.2 Product Complaints

14.3 Product Recalls

15. Change Control

16. Internal Audit

16.1 Principles

16.2 Approach

16.3 Traceability

17. Documentation

17.1 Principles

17.2 Types of Documents

17.3 Document Preparation, Approval, and Distribution

17.4 Revisions

17.5 Document Retention

Conclusion

ISO 22716 is an essential standard for ensuring the safety and quality of cosmetic products, helping organizations comply with internationally recognized GMP requirements.
By implementing this standard, companies can enhance the reliability of their manufacturing processes, build consumer trust, and strengthen their competitiveness in the global cosmetics market.