What is ISO 22716?
ISO 22716 is an international standard that outlines Good Manufacturing Practices (GMP) specifically for the cosmetics industry. Published in 2007, it provides comprehensive guidelines for the production, control, storage, and shipment of cosmetic products. The standard aims to ensure that cosmetics are manufactured safely and meet quality requirements, thereby protecting consumer health.
Key Guidelines of ISO 22716
ISO 22716 encompasses several critical guidelines to ensure the efficacy of cosmetic products:
- Personnel and Premises: Ensures that employees are adequately trained and that facilities maintain high standards of cleanliness to minimize contamination risks.
- Equipment and Materials: Stipulates that all equipment must be suitable for its intended purpose, properly maintained, and that raw materials are well-organized and labeled.
- Production and Quality Control: Emphasizes the importance of following established procedures throughout the production process to maintain product quality.
- Complaints and Recalls: Requires companies to have systematic procedures for addressing complaints and conducting recalls if necessary.
Details of ISO 22716 Clauses
| Clause Number | Title | Product Description |
| Clause 1 | Scope | Determines where the standard applies. |
| Clause 2 | Terms and Definitions | Provides definitions of key terms. |
| Clause 3 | Personnel | Focuses on staff competence and cleanliness. |
| Clause 4 | Facilities | Establishes facility standards for cleanliness. |
| Clause 5 | Equipment | Ensures suitability and cleanliness of equipment. |
| Clause 6 | Raw Materials and Packaging | Guarantees quality and storage. |
| Clause 7 | Production | Covers production controls and conditions. |
| Clause 8 | Finished Products | Ensures product quality before release. |
| Clause 9 | Quality Control Laboratory | Specifies laboratory requirements. |
| Clause 10 | Handling Non-Compliant Products | Deals with below-standard products. |
| Clause 11 | Deviations | Addresses deviations from standard procedures. |
| Clause 12 | Complaints and Recalls | Guidelines for handling complaints and recalls. |
| Clause 13 | Change Control | Manages changes to processes or materials. |
| Clause 14 | Internal Audit | Details internal audit procedures. |
| Clause 15 | Documentation | Requires comprehensive record-keeping. |
| Clause 16 | Subcontracting | Guidelines for managing subcontractors. |
| Clause 17 | Deviation Management | Addresses systematic handling of deviations. |
Benefits of Implementing ISO 22716
Adopting ISO 22716 can provide numerous advantages for cosmetic manufacturers:
- Enhanced Product Safety: By reducing hazards associated with cosmetic products, companies can ensure a higher level of safety for consumers.
- Market Recognition: Achieving ISO certification signifies a commitment to quality, enhancing brand loyalty and marketability.
- Risk Management: The standard aids in identifying and controlling risks throughout the supply chain, promoting continuous improvement.
- Integration with Other Standards: ISO 22716 can be integrated with other management systems such as ISO 9001 (Quality Management) and ISO 14001 (Environmental Management), facilitating a holistic approach to compliance and quality control
INSIGHTOF, Your Partner in Cosmetic Registration
At INSIGHTOF Consulting Indonesia, we specialize in helping businesses navigate the regulatory landscape for cosmetic product registration in Indonesia. While we do not provide ISO certification services, we offer essential support in the registration process that requires ISO certification. Our services include:
- Guidance on Regulatory Compliance: We help businesses understand and fulfill the necessary requirements for cosmetic registration, including adherence to ISO standards.
- Documentation Support: Assistance in preparing the required documentation for regulatory submissions, ensuring compliance with Indonesian regulations.
- Expert Consultation: Our team provides expert advice on best practices in GMP, helping companies implement effective quality management systems.
Access ISO 22716 Here: https://www.iso.org/obp/ui/en/#iso:std:iso:22716:ed-1:v2:en
