Cosmetics GMP, ISO 22716 Certification

What is ISO 22716 Certification?

ISO 22716 Certification gives the right method of production, storage, control and shipment. This will orient you to good manufacturing practices which must be complied by all employees regardless of the position. It also includes the research and development of cosmetics that can benefit the consumers health.

Standards of ISO 22716 Certification

ISO 22716 Requirements cover:

  1. Organization
  2. Risk Assessment of the proceses
  3. Infrastructure and Equipments
  4. Training and Competency
  5. Good Manufacturing Practices
  6. Hygiene, Cleaning and Sanitization
  7. Maintenance and Calibration
  8. Recall

The requirements of the standard are:

  1. Scope
  2. Terms and Definition
  3. Personnel
    1. Key Responsibilities
    2. Management Responsibilities
    3. Training
      1. Training and Skills
    4. Personnel Hygiene and Health
    5. Visitors and untrained personnel
  4. Premises
    1. Principle
    2. Types of Area
    3. Space
    4. Flow
    5. Floors, Walls, Ceilings, Windows
    6. Washing and Toilet facilities
    7. Lighting
    8. Ventilation
    9. Pipe work drains and ducts
    10. Cleaning and sanitization
    11. Maintenance
    12. Consumables
    13. Pest Control
  5. Equipment
    1. Equipment Design
    2. Installation
    3. Calibration
    4. Cleaning and Sanitization
    5. Maintenance
    6. Consumables
    7. Authorizations
    8. Back up systems
  6. Raw Materials and packaging materials
    1. The guiding principle
    2. Purchasing
    3. Critical and Non-critical raw material
  7. Production
    1. Guiding Principle
    2. Manufacturing Operations
      1. Availability of relevant document
      2. Startup Checks
      3. Assignment of a batch number
      4. Identification and in process Operations
      5. In process Controls
      6. Bulk Product Storage
      7. Restocking and Raw Materials
    3. Packaging Operations
      1. Availability of relevant documents
      2. Startup checks
      3. Assignment of Batch number
      4. Packing Line Identification
      5. Checks of on line Control Equipment
      6. In-process
      7. Re-stocking of packaging materials
      8. Identifications
  8. Finished products
    1. Guiding Principle
    2. Release
    3. Storage
    4. Shipment
    5. Returns
  9. Quality Control calibrations
    1. Guiding Principle
    2. Test Methods
    3. Acceptance Criteria
    4. Results
    5. Out of specification results
    6. Reagents, solutions, reference standards, culture, media
    7. Sampling
    8. Retain Sample
  10. Treatment of product that is out of specification
    1. Rejected finished products, bulk products, raw materials and packaging
  11. Waste Management
    1. Guiding Principle
    2. Types of waste
    3. Food
    4. Containers
    5. Disposal
  12. Sub contracting
    1. Types of Subcontract
    2. Manufacturing
      1. Packaging
      2. Analysis
      3. Equipment
      4. Pest Control
    3. Contract given
    4. Contract Acceptor
    5. Written contract agreement
  13. Handling of Deviations
  14. Complaints and Recalls
    1. Product complaint
    2. Product recalls
  15. Change Control
  16. Internal Audit
  17. Documentation
    1. Types of document (Procedures—Instructions, specifications, protocols, reports)