Saturday, July 13 2024

What are the recommendations of the ISO 22716 standard?

ISO 22716 is an international standard for good manufacturing practices (GMP) for cosmetic products. The standard defines specific recommendations for cosmetic products, such as:

  • Safety of cosmetic products
  • Compliance with regulatory requirements
  • Risk management

 

The ISO 22716 standard is divided into 17 chapters (clauses). The 311 recommendations (requirements) are in chapters 4 to 17. The chapters cover the following areas:

1. Scope

The standard specifies recommendations (guidelines) for good manufacturing practices applicable to organizations involved in the manufacturing, packaging, storage and distribution of cosmetic products.

2. Terms and definitions

The standard defines terms used in the context of ISO 22716.

3. Personnel

Principle: Personnel should have appropriate training.

The recommendations concern:

  • The organization
  • Key responsibilities
  • Training
  • Personnel hygiene and health
  • Visitors

 

4. Premises

Principle: The premises should be suitable:

  • product protection is ensured
  • maintenance and cleaning are carried out
  • the risk of mixing products, raw materials and packaging items is minimal

 

The recommendations concern:

  • Types of zones
  • Space
  • The flow
  • Floors, walls, ceilings and windows
  • Washing and toilets facilities
  • Lighting
  • Ventilation
  • Pipework, drains and ducts
  • Cleaning and sanitization
  • Maintenance
  • Consumables
  • Pest control

 

5. Equipment

Principle: Equipment should be adapted, cleaned and sanitized.

The recommendations concern:

  • Equipment design
  • Installation
  • Calibration
  • Cleaning and sanitization
  • Maintenance
  • Consumables
  • Authorizations
  • Back-up systems

 

6. Raw materials

Principle: Raw materials and packaging items should be appropriate for the quality of the finished products.

The recommendations concern:

  • Purchasing
  • receipt
  • Identification and status
  • Release
  • Storage
  • re-evaluation
  • Water quality

 

7. Production

Principle: Measures should be taken to ensure that finished products correspond to the defined characteristics.

The recommendations concern:

  • Manufacturing operations
  • Packaging operations

 

8. Finished products

Principle: Finished products should correspond to the defined acceptance criteria.

The recommendations concern:

  • Release
  • Storage
  • Shipment
  • Returns

 

9. Laboratory

Principle: The principles on personnel, premises, equipment, subcontracting and documentation should apply to the quality control laboratory.

The recommendations concern:

  • Test methods
  • Acceptance criteria
  • Results
  • Out-of-specification results
  • Reagents, solutions, standards and culture media
  • Sampling
  • Retain sample

 

10. Treatment of out-of-specification products

The recommendations concern:

  • Raw materials, packaging items, and rejected products
  • Bulk products and reprocessed finished products

 

11. Waste

Principle: Waste should be disposed of at the appropriate time and using appropriate systems.

The recommendations concern:

  • Type of waste
  • Flow
  • Containers
  • Disposal

 

12 Subcontracting

Principle: A contract should be established for subcontracting activities.

The recommendations concern:

  • Types of subcontracting
  • Contract giver
  • Contract acceptor
  • Contract

 

13. Deviations

The recommendations concern:

  • Specified requirements
  • Corrective actions

 

14. Complaints and recalls

Principle: Complaints should be handled appropriately.

The recommendations concern:

  • Product complaints
  • Product recalls

 

15. Change control

Principle: Changes should be handled by authorized personnel.

16. Internal audit

Principle: Internal audit should be used to monitor the application of Good Manufacturing Practices.

The recommendations concern:

  • Approach
  • Follow-up

 

17. Documentation

Principle: Each company should apply its own appropriate documentation system.

The recommendations concern:

  • Type of document
  • Writing, approval and distribution
  • Revision
  • Archiving

 

Chapter 18 of the training covers the regulatory requirements linked to the marketing of cosmetic products.

 

Organizations that can demonstrate compliance with the recommendations of ISO 22716 can obtain ISO 22716 certification.

ISO 22716 certification has numerous benefits for organizations involved in the cosmetics industry, including:

  • Safety of cosmetic products
  • Compliance with regulatory requirements
  • Improving customer satisfaction
  • Simplifying access to markets
  • Reducing the risk of recalls
  • Cost reduction
  • Improving competitiveness