July 25, 2025

ISO 22716: Cosmetic GMP Requirements, Checklist and Compliance Guide

ISO 22716:2007 is the international standard for Good Manufacturing Practices (GMP) for cosmetic products. It provides guidelines for the production, control, storage, and shipment of cosmetics and establishes a structured approach to maintaining product quality throughout manufacturing operations.

The standard covers key areas such as personnel, premises, equipment, raw materials, production, quality control, finished products, complaints and recalls, internal audits, and documentation.

ISO 22716 is applicable to cosmetic manufacturing and remains the current edition of the standard.

What Is ISO 22716?

ISO 22716 provides Good Manufacturing Practice guidelines specifically for the cosmetics industry. It establishes organizational and operational controls that help ensure cosmetic products are manufactured and controlled consistently according to defined quality requirements.

The standard applies to the production, control, storage, and shipment of cosmetic products. It focuses on product quality aspects of GMP and does not cover research and development activities or the distribution of finished products.

ISO 22716 can apply to the manufacture of products such as:

Skincare products
Makeup and color cosmetics
Haircare products
Personal care products
Fragrances
Creams and lotions
Shampoos and conditioners

The exact regulatory classification of a cosmetic product depends on the market where it is supplied.

Why ISO 22716 Is Important for Cosmetic Manufacturing

Cosmetic manufacturing involves raw materials, formulations, production equipment, filling operations, packaging components, storage, and handling. Weak controls at any stage can lead to contamination, material mix-ups, incorrect formulations, packaging errors, or inconsistent product quality.

Implementing ISO 22716 helps establish controls for:

Manufacturing processes
Personnel and hygiene
Facility cleanliness
Equipment maintenance
Raw material handling
Packaging operations
Quality control
Finished product release
Storage and handling
Documentation and traceability
Complaints and recalls

ISO 22716 focuses on manufacturing practices and process controls, while finished cosmetic products may also undergo cosmetic product inspection to verify appearance, fill quantity, packaging, labeling, functionality, and other defined quality requirements before shipment.

ISO 22716 GMP Requirements

ISO 22716 addresses the main operational areas involved in cosmetic manufacturing and quality control.

Personnel

Personnel should have appropriate knowledge, experience, training, and responsibilities for their assigned activities.

Key controls include:

Clearly defined responsibilities
Appropriate GMP training
Personnel hygiene
Suitable protective clothing
Procedures for visitors and untrained personnel

Personnel practices should support hygienic production and reduce the risk of product contamination.

Premises

Cosmetic manufacturing facilities should be designed and maintained to support production, cleaning, storage, and contamination control.

Important considerations include:

Adequate working space
Defined production and storage areas
Appropriate movement of materials and personnel
Cleaning and sanitation
Pest control
Waste management
Prevention of contamination and mix-ups

Production areas should be maintained in a condition suitable for the activities performed.

Equipment

Equipment should be suitable for its intended use and maintained in appropriate working condition.

Controls may include:

Equipment identification
Cleaning
Maintenance
Calibration where appropriate
Authorized use
Equipment condition monitoring

Equipment layout should also allow appropriate cleaning, maintenance, and operation.

Raw Materials and Packaging Materials

Raw materials and packaging components should be controlled from receipt through their use in production.

Typical controls include:

Receiving checks
Material identification
Acceptance criteria
Storage conditions
Release status
Traceability
Inventory management

Packaging materials also require appropriate control because incorrect bottles, containers, closures, labels, or printed components can affect finished product quality and identification.

Production

Cosmetic production should follow defined manufacturing procedures and instructions.

Important controls include:

Approved production documentation
Verification of materials before production
Equipment readiness
Batch identification
In-process controls
Recording of manufacturing activities
Management of deviations
Prevention of contamination and mix-ups

Production records should provide sufficient information to trace relevant manufacturing activities for each batch.

Finished Products

Finished cosmetic products should meet defined acceptance criteria before release.

Controls may include:

Product identification
Batch status
Product specifications
Release procedures
Storage conditions
Traceability
Stock management

Products awaiting release, approved products, and rejected products should be appropriately identified and controlled.

Quality Control

Quality control activities are used to verify whether materials and products meet established specifications.

These activities may include:

Sampling
Testing
Defined specifications
Test methods
Recording results
Product release decisions
Retention samples where applicable

Sampling and testing procedures should be appropriate to the materials and cosmetic products being evaluated.

Treatment of Non-Conforming Products

Materials or products that do not meet established specifications should be identified and controlled.

Procedures should address:

Identification
Segregation
Investigation
Evaluation
Reprocessing where appropriate
Final disposition
Documentation

These controls help prevent rejected or non-conforming materials from being unintentionally used or released.

Complaints and Recalls

Procedures should be established for handling quality complaints and product recalls.

The system should support:

Complaint recording
Investigation
Batch identification
Evaluation of quality problems
Corrective action
Recall procedures
Traceability

Complaint information should be reviewed where appropriate to identify recurring quality problems.

Internal Audits

Internal audits help evaluate whether GMP activities are properly implemented and maintained.

Audit findings should be documented, and identified deficiencies should be followed by appropriate corrective actions.

Documentation

Documentation provides instructions for manufacturing and quality activities and records evidence that required procedures have been followed.

Typical GMP documentation includes:

Standard Operating Procedures (SOPs)
Manufacturing instructions
Batch records
Equipment records
Cleaning records
Material records
Quality control records
Deviation records
Complaint and recall records
Internal audit records

Documents should be controlled, current, identifiable, and available where required.

ISO 22716 Checklist for Cosmetic GMP

An ISO 22716 checklist can help evaluate whether important GMP controls are implemented across a cosmetic manufacturing facility.

GMP Area	Key Checks
Personnel	Responsibilities, hygiene, training
Premises	Cleanliness, layout, pest control, contamination prevention
Equipment	Suitability, cleaning, maintenance, calibration where applicable
Raw Materials	Receipt, identification, storage, acceptance, traceability
Packaging Materials	Identification, storage, handling, printed component controls
Production	Manufacturing instructions, batch identification, in-process controls
Finished Products	Specifications, identification, release, storage
Quality Control	Sampling, testing, specifications, records
Non-Conforming Products	Identification, segregation, investigation, disposition
Complaints and Recalls	Investigation, traceability, documented procedures
Internal Audits	Audit findings and corrective actions
Documentation	SOPs, records, document control

The checklist should be adapted to the facility, products, manufacturing processes, and applicable regulatory requirements.

Common ISO 22716 Non-Conformities

GMP audits may identify deficiencies in production controls, facility management, material handling, documentation, or quality systems.

Common findings include:

Non-Conformity	Example
Incomplete Records	Missing dates, signatures, batch information, or required entries
Poor Material Identification	Material status or identity is unclear
Cleaning Control Issues	Cleaning procedures or records are incomplete
Equipment Maintenance Gaps	Required maintenance is overdue or undocumented
Weak Traceability	Materials cannot be clearly traced to production batches
Inadequate Segregation	Rejected materials are not properly separated
Uncontrolled Documents	Obsolete procedures remain available for use
Production Deviations	Deviations are not adequately documented or investigated
Packaging Control Issues	Incorrect or uncontrolled printed packaging components
Complaint Investigation Gaps	Quality complaints are not adequately investigated

Corrective actions should address the identified problem and provide appropriate evidence that the required controls have been implemented.

ISO 22716 Internal Audit and GMP Inspection

An ISO 22716 GMP audit evaluates whether the manufacturing facility has established and implemented appropriate cosmetic GMP controls.

Depending on the audit scope, the assessment may review:

Facility and production conditions
Hygiene practices
Raw material controls
Equipment condition and maintenance
Production procedures
Batch manufacturing records
Packaging operations
Quality control procedures
Finished product release
Storage conditions
Traceability
Complaint and recall procedures
Internal audit records
Document control

Auditors may also trace selected batches through different stages of production to determine whether materials, manufacturing activities, testing, packaging, and release records can be linked effectively.

Any identified non-conformities should be documented and followed by appropriate corrective action.

ISO 22716 Certification: Is It Required?

ISO 22716 implementation and ISO 22716 certification are separate considerations.

A cosmetic manufacturer can implement the GMP guidelines established by ISO 22716. An independent audit or certification may then be used to provide additional evidence that the facility’s GMP system conforms to defined requirements.

Whether formal certification is required depends on the applicable regulatory requirements, destination market, customer requirements, and commercial arrangements.

This distinction is important because a regulatory requirement to follow cosmetic GMP does not automatically mean that every cosmetic manufacturer must hold an ISO 22716 certificate.

ISO 22716 and EU Cosmetics Regulation

Good Manufacturing Practice is a legal requirement for cosmetic manufacturing under Regulation (EC) No 1223/2009 on cosmetic products.

Article 8 requires the manufacture of cosmetic products to comply with GMP. Compliance with GMP is presumed where manufacturing follows the relevant harmonised standards whose references have been published in the Official Journal of the European Union.

ISO 22716 provides the recognized GMP framework covering areas such as:

Manufacturing controls
Personnel and premises
Equipment
Raw materials
Production
Quality control
Finished products
Documentation
Complaints and recalls

GMP forms one part of EU cosmetic compliance. Other requirements under the Cosmetics Regulation address areas such as product safety assessment, the Cosmetic Product Safety Report (CPSR), Product Information File (PIF), responsible person obligations, notification, ingredients, and labeling.

Best Practices for Cosmetic GMP Compliance

Maintaining cosmetic GMP requires consistent control throughout manufacturing operations.

Recommended practices include:

Maintain clear and current SOPs
Establish defined raw material acceptance procedures
Control material and product status throughout production
Monitor facility cleaning and sanitation
Maintain manufacturing equipment according to defined schedules
Complete batch records accurately
Verify packaging materials before use
Investigate production deviations
Maintain batch traceability
Review quality complaints
Conduct periodic internal audits
Track corrective actions through closure

GMP controls should reflect actual manufacturing practices and remain consistent with the products and processes used at the facility.

ISO 22716 provides a structured framework for controlling the production, quality control, storage, and shipment of cosmetic products. Effective implementation requires clear procedures, controlled manufacturing processes, reliable records, material traceability, and regular review of GMP activities.