ISO 22716:2007
What is ISO 22716 Certification – Cosmetics GMP
An ISO 22716 Good Manufacturing Practices (GMP) certification audit assesses your manufacturing practices across cosmetic product production, control, storage and shipment.
ISO 22716 provides GMP guidance for the cosmetics industry, describing the basic principles for applying GMP in finished cosmetics manufacturing plants. The standard offers guidance on personnel, technology and administrative management that will affect product quality in related organizations and practices. It is not applicable to research and development activities and distribution of finished products.
Our experienced network of auditors can support and assess your compliance with ISO 22716.
Why choose an ISO 22716 certification audit from GlobalCert?
We assess your manufacturing practices against the certification guidance, enabling you to:
- Confirm compliance with ISO 22716 GMP requirements
- Produce products that meet quality requirements and safety regulations
- Reduce the risk of pollution and errors
- Enhance partnerships with international leading brands
- Improve consumer trust
- Break through international trade barriers
Aligning with the UN Sustainable Development Goals (SDGs)
ISO 22716 contributes to UN Sustainable Development Goals three and eight.
Trusted ISO 22716 GMP certification audits from a world leader
As the world’s leading certification, testing, verification and inspection company, we provide in-depth expertise in ISO 22716 GMP requirements.
We also provide a range of complementary services, including basic, internal auditor and standard clause interpretation training courses.
The purpose of ISO 22716 Certification is to ensure the safe, hygienic, and consistent manufacture of cosmetic products through internationally recognized Good Manufacturing Practices, while supporting regulatory compliance, consumer protection, and global market access.
Purpose of ISO 22716 Certification – Cosmetics GMP Certification
ISO 22716:2007 provides guidelines on Good Manufacturing Practices (GMP) for cosmetic products. The main purpose of ISO 22716 Certification is to ensure that cosmetic products are consistently produced and controlled to meet quality and safety requirements, in compliance with applicable regulations.
Below is a clear and professional explanation of its purpose.
1. Ensure Consumer Safety
To minimize risks of:
Microbiological contamination
Chemical and physical contamination
Product mix-ups and labeling errors
To ensure cosmetic products are safe for their intended use.
2. Establish Good Manufacturing Practices (GMP)
To define standardized GMP requirements for:
Personnel hygiene and training
Premises and equipment
Production, packaging, and storage
To promote clean, controlled, and hygienic manufacturing environments.
3. Support Regulatory Compliance
To help organizations comply with:
EU Cosmetics Regulation (EC) No. 1223/2009
ASEAN Cosmetic Directive (ACD)
Other national and international cosmetic regulations
To provide a globally recognized GMP framework for cosmetics.
4. Ensure Consistent Product Quality
To achieve batch-to-batch consistency in cosmetic products.
To control critical processes that affect product quality.
To reduce variability in manufacturing and packaging operations.
5. Strengthen Process Control & Documentation
To ensure:
Proper documentation of procedures and records
Traceability of raw materials, packaging materials, and finished products
To enable effective investigation of deviations and complaints.
6. Enable Effective Product Recall & Complaint Handling
To establish systems for:
Handling customer complaints
Performing product recalls when necessary
To protect consumers and brand reputation.
7. Improve Organizational Discipline & Accountability
To clarify roles and responsibilities in cosmetic manufacturing.
To enhance staff awareness of GMP and quality responsibilities.
8. Build Market & Stakeholder Confidence
To demonstrate commitment to international GMP standards.
To increase trust among:
Regulators
Distributors
Retailers
Consumers
9. Facilitate International Trade
To serve as a common GMP reference accepted globally.
To reduce technical barriers to trade in cosmetic products.
Benefits of ISO 11135:2014 Certification
- Enhanced Product Quality & Safety: Standardizes processes from raw materials to finished goods, minimizing defects and ensuring product safety.
- Increased Consumer & Partner Trust: Shows commitment to quality, building confidence with consumers and international brands.
- Regulatory Compliance: Helps meet legal requirements in different markets, simplifying market entry, especially for the EU (EC 1223/2009).
- Improved Efficiency & Cost Reduction: Streamlines operations, eliminates redundant tasks, and minimizes costly recalls or non-compliance issues.
- Global Market Access: Facilitates international trade by aligning with recognized best practices, reducing barriers.
- Risk Management: Provides a framework to identify and control hazards, preventing quality issues before they escalate.
- Competitive Advantage: Positions your company as a leader, enhancing reputation and retention with key clients.
- Business Improvement Tool: Offers a flexible system applicable to all company sizes, easily integrated with other standards like ISO 9001.
Steps to Certification
Step 1
Complete a Quote Request Form so we can understand you and your business. We will then use this to personally prepare a proposal for your certification and define what is known as your ‘scope of assessment’.
Step 2
We will then contact you to book your assessment with an GlobalCert assessor. It consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been operational for a minimum of three months and has been subject to a management review and a full cycle of internal audits.
Step 3
Following a successful stage two audit, a decision is made. If positive, your certification will be issued by GlobalCert, with both a hard and soft copy of the certificate awarded. Certification is valid for three years and maintained through surveillance audits (years one and two) and a recertification audit in year three.
Why choose ISO 22716 Certification – Cosmetics GMP?
- Choosing ISO 22716 for Cosmetics GMP ensures your products meet global safety and quality standards, builds consumer trust through documented best practices in production, control, storage, and distribution, enhances your brand’s international market access, reduces risks like recalls, and boosts operational efficiency by optimizing processes for quality and compliance. It’s a specific, harmonized standard for the cosmetics industry that complements systems like ISO 9001, demonstrating a serious commitment to product excellence.Key Benefits of ISO 22716 Certification:
- Enhanced Product Safety & Quality: Provides clear guidelines for personnel, premises, equipment, and processes, ensuring safe, consistent, and high-quality products.
- Global Market Access: A globally recognized standard, crucial for exporting, as it assures regulatory bodies and buyers worldwide of your compliance.
- Increased Consumer Trust: Signals a commitment to rigorous standards, fostering customer confidence and loyalty in a competitive market.
- Risk Reduction: Minimizes errors, contamination, and mislabeling, helping to avoid costly recalls and legal issues.
- Improved Efficiency: Streamlines operations and documentation (materials, production, storage, distribution), leading to better management and cost control.
- Regulatory Compliance: Helps meet legal requirements, including those for adverse event reporting (like under MoCRA in the US).
- Competitive Edge: Differentiates your brand by proving adherence to internationally recognized GMP, a significant advantage over non-certified competitors.
What it Covers:- Personnel Training & Hygiene
- Premises & Equipment
- Production & In-Process Controls
- Materials Management
- Storage & Distribution
- Documentation & Records
- Complaint Handling & Recalls
- Internal Audits & Quality Control
