ISO 22716:2007
Good Manufacturing Practices for cosmetics
Introduction
ISO 22716:2007 is the internationally recognised standard for Good Manufacturing Practices (GMP) in the cosmetics industry.
It provides guidelines for the production, control, storage, and shipment of cosmetic products, ensuring that they are consistently manufactured to meet safety, quality, and regulatory requirements. The standard is designed to align with both international regulations and industry best practices, helping cosmetic manufacturers maintain high standards in product safety and traceability.
ISO 22716 applies to all organisations involved in the cosmetics supply chain, including manufacturers, suppliers, and distributors. Certification demonstrates a company’s commitment to quality, regulatory compliance, and consumer safety, making it essential for businesses aiming to operate in global markets.
ISO 22716 applies to all organisations involved in the cosmetics supply chain, including manufacturers, suppliers, and distributors. Certification demonstrates a company’s commitment to quality, regulatory compliance, and consumer safety, making it essential for businesses aiming to operate in global markets.
Why ISO 22716 Matters?
Ensuring Product Safety and Quality
The standard establishes a systematic approach to minimising contamination risks and quality inconsistencies during cosmetic product manufacturing, ensuring consumer safety.
Risk Management and Traceability
The standard ensures that every step of the manufacturing process is documented and traceable. This allows organisations to quickly identify and address any product safety issues, reducing the risk of non-compliance.
Improved Manufacturing Processes
By implementing GMP guidelines, companies can enhance their production efficiency, reduce defects, and ensure the consistent quality of their products. This leads to fewer recalls and customer complaints.
Stronger Market Access and Competitive Advantage
Many retailers, distributors, and regulatory agencies prefer or mandate working with ISO 22716-certified manufacturers. Certification enhances credibility, supports international trade, and facilitates market entry.
Compliance with Regulatory Requirements
Many regulatory bodies, including the European Union’s Cosmetic Regulation (EC) No 1223/2009, require cosmetic manufacturers to follow GMP principles outlined in ISO 22716. Certification helps organisations comply with international legal and regulatory requirements.
Integration with
Other Management Systems
ISO 22716 can be integrated with other standards such as ISO 9001 (Quality Management) and ISO 14001 (Environmental Management), improving overall business operations and efficiency.
Key Requirements of ISO 22716
ISO 22716 sets guidelines for Good Manufacturing Practices (GMP) in cosmetics production, covering all aspects of the supply chain. The main focus areas include:
-
Quality Management and Documentation
Organisations must establish clear quality management policies and document all procedures related to production, quality control, storage, and distribution. Proper documentation ensures consistency, traceability, and compliance with regulations. -
Personnel and Training
Employees involved in manufacturing must be trained in hygiene, safety, and GMP principles. Regular training sessions ensure that staff understand their roles in maintaining quality and preventing contamination. -
Premises and Equipment
Facilities must be designed to prevent contamination and allow for efficient cleaning and maintenance. Equipment used in production, packaging, and testing must be regularly maintained and calibrated to ensure product quality. -
Raw Material and Packaging Control
Organisations must implement strict controls on the selection, storage, and handling of raw materials and packaging components to prevent contamination and quality issues. All suppliers should be evaluated to ensure they meet GMP requirements. -
Production and Process Control
Manufacturers must follow defined procedures for production, ensuring that all processes, from formulation to packaging, are carried out under controlled conditions. Each batch must be monitored, recorded, and verified for compliance with quality standards. -
Quality Control and Testing
Regular quality checks and laboratory testing must be conducted to ensure products meet safety and performance standards before release. Any deviations from specifications must be addressed through corrective actions. -
Storage and Distribution
Finished products must be stored under appropriate conditions to maintain stability and safety. Organisations must implement procedures to prevent contamination, deterioration, or mix-ups during storage and distribution. -
Handling of Deviations, Complaints, and Recalls
The standard requires a system for handling product deviations, customer complaints, and recalls. In case of a safety issue, organisations must have clear procedures for investigating, correcting, and communicating problems to relevant authorities and stakeholders.
Who Needs ISO 22716?
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Cosmetic Manufacturers
Ensuring safe and high-quality production of skincare, haircare, makeup, and personal care products. -
Raw Material and Ingredient Suppliers
Ensuring that raw materials meet GMP requirements and are safe for use in cosmetic formulations. -
Packaging and Labelling Companies
Preventing contamination and ensuring the quality of packaging materials used in cosmetic products. -
Distributors and Retailers
Strengthening supply chain integrity and ensuring that products meet regulatory and consumer safety requirements.
Certification Process
To achieve ISO 22716 certification, organisations must follow a structured implementation process:
1
Gap Analysis and Initial Assessment
The organisation evaluates its current manufacturing practices against ISO 22716 requirements to identify areas for improvement before certification.
2
Development of GMP
Procedures and Documentation
Procedures and Documentation
The company establishes standard operating procedures (SOPs) for production, quality control, and distribution. These procedures must be documented and aligned with GMP requirements.
3
Implementation and
Employee Training
Employee Training
Staff receive training on GMP principles, hygiene protocols, and quality control measures. Ensuring that employees understand their roles in maintaining product safety is critical for compliance.
4
Internal Audits and
Management Review
Management Review
An internal audit is conducted to evaluate compliance with ISO 22716. Management reviews audit findings and implements corrective actions to address any non-conformities.
5
Certification Audit
An independent certification body conducts an audit to assess the organisation’s compliance with ISO 22716. This includes a review of documentation, production processes, quality controls, and risk management procedures. If all requirements are met, the organisation receives ISO 22716 certification.
6
Ongoing Compliance
and Recertification
and Recertification
After certification, regular surveillance audits are conducted to ensure continued adherence to GMP guidelines. Recertification is required every three years to maintain ISO 22716 compliance.