ISO 22716 GMP Compliance for Cosmetics

ISO 22716 is the globally recognized standard for Good Manufacturing Practices (GMP) in the cosmetics industry. Developed by the International Organization for Standardization, it provides a complete set of operational and organizational guidelines to ensure cosmetic products are consistently produced and controlled to meet quality and safety standards.

Unlike regulations designed for food or pharmaceuticals, ISO 22716 addresses the specific risks and processes associated with cosmetic product manufacturing, including:

• Production and in-process control
• Packaging and labeling procedures
• Storage and inventory handling
• Testing and quality review mechanisms

ISO 22716 is widely accepted across jurisdictions. In the European Union, compliance is essential under Regulation (EC) No 1223/2009. Many countries in Asia, Latin America, and the Middle East also reference ISO 22716 in their national cosmetic regulations or harmonization systems like the ASEAN Cosmetic Directive.

For manufacturers, following ISO 22716 helps:

• Prevent contamination, mix-ups, and batch errors
• Provide a documented trail of quality activities
• Build customer and regulatory trust

The standard also supports third-party audits, which serve as credible evidence of GMP implementation during supplier qualification or product certification.

Core Principles of ISO 22716 for Cosmetic Manufacturers

ISO 22716 sets clear expectations across every operational aspect of a cosmetics facility. Its strength lies in detailing how processes should be structured, monitored, and continuously improved to safeguard product quality and consumer safety.

Personnel

• Staff must receive GMP training relevant to their roles
• Hygiene protocols, protective clothing, and controlled movement within production zones are mandatory
• Responsibility and reporting lines must be clearly documented

Premises and Equipment

• Production areas must be designed to reduce contamination risk and allow for systematic cleaning
• Equipment must be suitable for intended use, calibrated regularly, and properly maintained

Raw Materials and Packaging

• Incoming materials require inspection, labeling, and quarantine before release
• Each material must be traceable from receipt to batch use
• Packaging must be appropriate for the product’s nature and shelf-life requirements

Production Controls

• Standard Operating Procedures (SOPs) must govern each step of manufacturing
• Deviations must be logged and investigated, with corrective action documented
• Environmental conditions (temperature, humidity) must be monitored where applicable

Quality Control

• Sampling must follow documented protocols
• Retention samples and stability testing are expected
• Finished product batches require documented release procedures

Documentation

• All activities must be recorded in real-time with version-controlled forms and logs
• Records must be retained for a period based on product shelf-life and regulatory requirements

The standard emphasizes a preventive approach, encouraging manufacturers to identify risks before failures occur. This structured system fosters accountability, transparency, and repeatable quality outcomes.

How Cosmetic Product Inspections Are Conducted Under ISO 22716

Cosmetic GMP inspections are formal evaluations of whether a facility’s practices align with ISO 22716 standards. These can be conducted by internal QA teams, customer auditors, or accredited third-party certifiers.

Pre-Inspection Preparation

• Ensure all SOPs, logs, batch records, and training files are updated
• Review previous audit findings and close any open corrective actions
• Organize the facility and confirm cleanliness, labeling, and zoning integrity

What Inspectors Review

Inspectors generally focus on high-risk areas, including:

• Raw material storage and handling conditions
• Batch manufacturing records, including weighing and mixing logs
• Cleaning validation and equipment maintenance logs
• Change control documents and deviation investigations
• Labeling controls and reconciliation of printed components

They also assess whether:

• Staff understand and follow GMP protocols
• Equipment is operating within validated parameters
• Traceability is maintained from raw material intake to final shipment

Inspections often follow a structured checklist aligned with ISO 22716 clauses. Any findings are classified by severity (e.g., critical, major, minor), and a Corrective and Preventive Action (CAPA) process must be initiated for resolution.

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ISO 22716 provides a practical, enforceable framework for manufacturing cosmetics that meet international safety and quality expectations. Consistent implementation reduces compliance risk, improves production consistency, and enhances brand credibility.

To safeguard your brand and meet regulatory expectations, align your cosmetic operations with ISO 22716 and schedule a professional GMP inspection through ECQA. Our compliance team supports manufacturers with tailored audits, documentation reviews, and system readiness evaluations.