ISO 22716 Certification in China: The Cosmetics GMP Guide Every Brand Should Know
China's cosmetics market includes manufacturers, OEM and ODM factories, private-label brands, ingredient suppliers, exporters, and international companies sourcing products from Chinese facilities. With so many parties involved in the cosmetic supply chain, maintaining consistent manufacturing and quality controls is essential.
ISO 22716 Certification in China provides a structured approach to Good Manufacturing Practices (GMP) for cosmetics. It focuses on how cosmetic products are produced, controlled, stored, and shipped, helping organizations establish consistent processes and maintain product quality. ISO states that ISO 22716:2007 remains the current edition and was last reviewed and confirmed in 2022.
However, companies operating in China should understand an important distinction: ISO 22716 is not a replacement for China's cosmetics regulatory requirements. China's National Medical Products Administration (NMPA) has its own Cosmetics Good Manufacturing Practice requirements, as well as registration, filing, manufacturing licensing, and other regulatory obligations.
For cosmetic brands and manufacturers, the real objective is therefore not simply obtaining a certificate. It is building manufacturing controls that can work in everyday production while meeting applicable Chinese and international requirements.
What Is ISO 22716 Certification?
ISO 22716 is an international guideline for Good Manufacturing Practices for cosmetic products.
It provides guidance covering areas such as:
Production
Quality control
Storage
Shipment
Personnel
Equipment
Raw materials
Packaging materials
Manufacturing operations
Documentation
Handling of nonconforming products
Complaints and recalls
The standard is designed around the quality aspects of cosmetic production. ISO specifically notes that it does not cover occupational safety or environmental protection, and it does not apply to research and development activities or the distribution of finished products.
For a Chinese cosmetics manufacturer, ISO 22716 can therefore provide a structured framework for controlling the activities that directly affect product quality.
Why Is ISO 22716 Important for Cosmetics Companies in China?
Cosmetic manufacturing involves many interconnected activities.
A formulation may be approved correctly, but problems can still occur if:
The wrong raw material is released into production.
Packaging components are not properly identified.
Cleaning procedures are inconsistently followed.
Production records are incomplete.
Equipment is not maintained appropriately.
Finished products are released without sufficient checks.
Employees are not adequately trained.
Complaints are recorded but not investigated effectively.
ISO 22716 addresses these types of operational controls by establishing a systematic GMP approach.
For companies supplying international brands, the framework can also help demonstrate that manufacturing processes are organized and controlled according to an internationally recognized cosmetics GMP guideline.
Who Needs ISO 22716 in China?
ISO 22716 can be relevant to a wide range of businesses involved in cosmetic manufacturing.
Chinese Cosmetic Manufacturers
Manufacturers producing skincare, haircare, personal-care, makeup, and other cosmetic products can use ISO 22716 to strengthen manufacturing and quality processes.
OEM and ODM Cosmetics Factories
OEM and ODM manufacturers often produce products for multiple brands. Consistent procedures become especially important when different formulations, packaging requirements, customer specifications, and production batches are managed at the same facility.
International Brands Sourcing From China
A brand may not operate its own factory in China but may depend heavily on a Chinese contract manufacturer.
In this situation, ISO 22716 can be useful when evaluating the manufacturer's GMP practices and quality controls.
Private-Label Cosmetic Businesses
Private-label companies working with Chinese manufacturers can use GMP requirements as part of their supplier evaluation and quality assurance approach.
Export-Oriented Manufacturers
Chinese cosmetic manufacturers supplying customers in different international markets may use ISO 22716 to demonstrate a structured approach to cosmetics GMP.
What Does ISO 22716 Cover?
ISO 22716 is broader than simply checking the cleanliness of a production room.
A practical implementation looks at the complete manufacturing environment.
1. Personnel
Employees should understand their responsibilities and receive appropriate training for the activities they perform.
This can include:
Hygiene practices
Job-specific training
GMP awareness
Production procedures
Quality responsibilities
Handling of materials
Documentation requirements
A company may have excellent procedures on paper, but they will not provide much value if employees do not understand how to apply them.
2. Premises and Facilities
The manufacturing environment should support controlled production.
Companies should consider:
Facility layout
Cleanliness
Material flow
Personnel movement
Storage areas
Production areas
Hygiene controls
Prevention of contamination
The objective is to reduce conditions that could negatively affect product quality.
3. Equipment
Equipment used during manufacturing should be suitable for its intended purpose and appropriately maintained.
Companies may need procedures covering:
Cleaning
Maintenance
Calibration where applicable
Equipment identification
Operating conditions
Records
For example, a manufacturer should be able to demonstrate that critical measuring equipment is maintained and controlled rather than simply assuming that it remains accurate.
4. Raw Materials and Packaging Materials
Cosmetic quality begins before production starts.
Manufacturers need controls for incoming materials, including appropriate identification, storage, inspection, and release.
Examples include:
Ingredients
Bulk materials
Containers
Caps
Labels
Cartons
Packaging components
Supplier controls are also important because poor-quality incoming materials can create problems that appear later in production.
5. Production Controls
Production should follow approved procedures rather than relying entirely on employee experience.
Controls can cover:
Batch preparation
Weighing
Mixing
Filling
Packaging
In-process checks
Identification of materials
Batch documentation
Clear production records help establish what was manufactured, when it was manufactured, which materials were used, and who performed key activities.
6. Quality Control
Quality control should be integrated into the manufacturing process.
Depending on the product and company's procedures, this can involve:
Sampling
Testing
Inspection
Acceptance criteria
Product release
Handling of rejected materials
Laboratory records
The purpose is to ensure that products are assessed against established requirements before release.
7. Storage
Finished products and materials need suitable storage conditions.
A manufacturer should have controls for:
Storage locations
Identification
Stock rotation
Temperature or other applicable conditions
Separation of approved and rejected materials
Prevention of damage or contamination
Poor storage controls can undermine otherwise well-controlled manufacturing processes.
8. Documentation and Records
Documentation is one of the areas where GMP systems can become difficult if procedures are created without considering actual operations.
Useful documentation may include:
Procedures
Work instructions
Specifications
Batch records
Inspection records
Cleaning records
Maintenance records
Training records
Complaint records
Deviation or nonconformity records
The important point is consistency between the documented procedure and what employees actually do.
ISO 22716 Certification vs China's Cosmetics GMP
This distinction is particularly important for businesses operating in China.
ISO 22716 is an international cosmetics GMP guideline covering the quality aspects of cosmetic production, control, storage, and shipment.
China also has a Good Manufacturing Practice for Cosmetics issued by the NMPA. The Chinese GMP requirements entered into force on July 1, 2022, and apply to cosmetics registrants, filing applicants, and entrusted manufacturers.
China's regulatory provisions also require cosmetics manufacturers to establish and maintain a quality management system and require cosmetics manufacturing to operate under the applicable GMP requirements. Manufacturing is subject to licensing requirements.
Therefore, a company should not assume:
ISO 22716 certificate = Chinese cosmetics regulatory approval.
They serve different purposes and should be considered together when developing a compliance strategy.
ISO 22716 and NMPA Requirements in China
The NMPA framework covers regulatory responsibilities beyond an ISO 22716 certification project.
For example, China's cosmetics registration and filing provisions establish requirements for cosmetic registration and filing activities. Applicants and filing persons must have an appropriate quality management system and the ability to monitor and evaluate adverse reactions.
China's manufacturing and marketing provisions also address traceability, quality management, adverse reactions, risk control, recalls, manufacturing licensing, and GMP compliance.
This means a cosmetic company entering the Chinese market may need to consider several areas at the same time:
ISO 22716 implementation
China's cosmetics GMP requirements
NMPA registration or filing
Cosmetics Manufacturing License requirements
Product safety and technical documentation
Ingredient requirements
Labeling requirements
Traceability
Complaint and adverse-reaction management
The exact obligations depend on the company's role, product type, manufacturing arrangement, and market activities.
What Does an ISO 22716 Audit Look At?
An audit is not simply a document review.
An auditor may look at whether the company's documented GMP system is actually being implemented.
For example, an auditor may ask:
Are employees following approved procedures?
Are raw materials properly identified and controlled?
Are production records complete?
Are cleaning activities documented?
Are equipment maintenance records available?
Are nonconforming products clearly controlled?
Are complaints investigated?
Are corrective actions followed through?
Are employees trained for their assigned responsibilities?
Are storage controls working in practice?
This is where the difference between having a GMP manual and operating a GMP system becomes important.
A Practical Example: Chinese Skincare Manufacturer
Consider a Chinese manufacturer producing facial creams for several international brands.
The company has:
Written production procedures
Employee training records
Raw material specifications
Quality-control procedures
Cleaning instructions
On paper, the system appears complete.
During an internal review, however, the company discovers that:
One production work instruction does not reflect the current mixing process.
Some batch records have incomplete operator signatures.
A supplier's latest evaluation has not been completed.
Cleaning records do not consistently identify the equipment cleaned.
A recurring customer complaint has been recorded but the root cause has not been properly investigated.
None of these issues can be solved simply by creating another policy.
The manufacturer needs to connect its documentation with actual factory operations.
That is the practical value of implementing GMP systematically.
How to Prepare for ISO 22716 Certification in China
A company preparing for certification should start with its current operations rather than immediately creating large amounts of documentation.
Step 1: Understand the Applicable Requirements
Identify which ISO 22716 requirements apply to the organization's activities and separately identify the Chinese regulatory obligations relevant to the products and manufacturing model.
Step 2: Conduct a Gap Assessment
Compare current practices with the required GMP controls.
Look at:
People
Facilities
Equipment
Materials
Production
Quality control
Documentation
Storage
Complaints
Recalls
Supplier controls
Step 3: Improve the Actual Processes
Close gaps in day-to-day operations before focusing only on audit documentation.
For example, if cleaning records are incomplete, improve the cleaning process and recordkeeping rather than simply adding another procedure.
Step 4: Train Employees
Employees should understand what has changed and why.
Training can focus on their actual responsibilities instead of giving everyone the same generic GMP presentation.
Step 5: Conduct an Internal Audit
An internal audit can identify weaknesses before an external certification audit.
The review should examine both documentation and implementation.
Step 6: Correct Findings
Problems identified during the internal audit should be investigated and corrected.
Where necessary, the company should determine the root cause rather than repeatedly fixing the same symptom.
Step 7: Prepare for the Certification Audit
Once the system is operating consistently, the company can proceed with the certification process through the applicable certification arrangements.
How Long Does ISO 22716 Certification Take in China?
There is no single timeline that applies to every organization.
The timeframe can depend on:
Factory size
Number of production lines
Existing GMP controls
Number of employees
Product range
Facility condition
Documentation maturity
Existing certifications
Number of manufacturing locations
Regulatory requirements
A company that already has a mature quality system may need less preparation than a manufacturer starting from the beginning.
The key factor is not simply how quickly documents can be written. The organization needs enough time to implement, train, operate, review, and improve the system.
What Documents Are Commonly Needed?
Documentation depends on the organization's activities, but a cosmetics GMP system may include:
GMP procedures
Quality procedures
Manufacturing procedures
Cleaning procedures
Equipment maintenance records
Training records
Supplier evaluation records
Raw material specifications
Packaging specifications
Batch manufacturing records
Quality-control records
Product release records
Complaint records
Recall procedures
Internal audit records
Corrective-action records
The exact documentation should reflect the company's real processes rather than creating unnecessary paperwork.
Common ISO 22716 Problems in Chinese Cosmetic Factories
Some recurring weaknesses can appear when a company focuses more on documentation than implementation.
Procedures Do Not Match Actual Work
An SOP may describe one process while employees use a newer process on the production floor.
Incomplete Records
A company may perform the activity correctly but fail to maintain sufficient evidence.
Weak Supplier Controls
Supplier approval may exist as a formality without meaningful evaluation or ongoing monitoring.
Inconsistent Employee Training
New employees may be trained initially but not receive appropriate refresher or job-specific training.
Poor Complaint Investigation
Complaints may be recorded without identifying why the problem occurred or whether similar batches are affected.
Weak Traceability
The company may struggle to quickly identify which raw materials, packaging components, production records, and finished batches are connected.
These weaknesses can create difficulties during customer audits, regulatory inspections, and certification assessments.
How MaxiCert Supports ISO 22716 Certification in China
For a cosmetics company, implementing ISO 22716 is not simply about preparing a manual and arranging an audit. The system needs to work across production, quality control, documentation, employee responsibilities, and supplier management.
MaxiCert can support businesses through the preparation and implementation stages of the certification process.
Our support can include:
Understanding the organization's current GMP practices
Conducting a gap assessment
Identifying weaknesses in documentation and implementation
Supporting the development and improvement of required procedures
Helping employees understand their GMP responsibilities
Supporting internal audit preparation
Reviewing readiness before the certification audit
Helping organizations address identified gaps
MaxiCert brings experience in supporting organizations with international compliance and certification requirements, with stated experience across multiple countries and industries.
For a Chinese cosmetics manufacturer, the focus should be on building a practical GMP system that employees can consistently follow—not simply preparing documents for an audit.
What Should a Cosmetics Brand Check Before Choosing a Chinese Manufacturer?
If you are an international cosmetics brand sourcing from China, ISO 22716 certification can be one useful part of supplier evaluation.
However, it should not be the only question.
Consider asking the manufacturer about:
GMP certification or compliance status
Manufacturing license
Production facilities
Quality-control processes
Raw material controls
Supplier qualification
Batch traceability
Product testing
Complaint handling
Recall procedures
Employee training
Internal audits
Regulatory responsibilities
Experience with your target markets
A certificate provides useful information, but a supplier assessment should also consider how the facility actually operates.
Is ISO 22716 Certification Required for Every Cosmetic Company in China?
ISO 22716 and China's mandatory cosmetics GMP requirements should not be treated as the same requirement.
China's NMPA has established its own Good Manufacturing Practice requirements for cosmetics, and applicable manufacturers must comply with the Chinese regulatory framework.
ISO 22716 is an international GMP guideline that can provide an additional structured framework for cosmetic manufacturing quality.
Whether a particular company needs ISO 22716 certification depends on its business model, customer requirements, target markets, contractual expectations, and regulatory situation.
Why ISO 22716 Matters Beyond the Certificate
A cosmetics GMP system should not exist only because an audit is scheduled.
When properly implemented, it can help a manufacturer create greater consistency across:
Raw materials → Production → Quality control → Storage → Release → Shipment → Complaints → Improvement
This connected approach is particularly useful for Chinese manufacturers serving multiple brands or international markets.
The certificate may demonstrate conformity with the applicable certification requirements, but the day-to-day value comes from the processes behind it.
Conclusion
ISO 22716 certification in China can help cosmetics manufacturers establish a structured approach to Good Manufacturing Practices across production, quality control, storage, documentation, and shipment.
But companies should understand the difference between ISO 22716 and China's own cosmetics regulatory framework. NMPA requirements cover areas such as cosmetics GMP, manufacturing licensing, registration and filing, traceability, and other regulatory responsibilities.
For manufacturers, OEM and ODM factories, private-label businesses, and international brands sourcing cosmetics from China, the strongest approach is to look beyond the certificate and examine how GMP controls work in actual operations.
A well-designed system should make it easier to control materials, train employees, maintain production records, investigate problems, trace products, and respond when something goes wrong.
That is what turns cosmetics GMP from a compliance exercise into a practical quality-management system.
FAQs
1. What is ISO 22716 certification in China?
ISO 22716 certification demonstrates conformity with an international cosmetics GMP framework covering areas such as production, quality control, storage, and shipment.
2. Is ISO 22716 the same as China's NMPA cosmetics GMP?
No. ISO 22716 is an international cosmetics GMP guideline, while China has its own regulatory Good Manufacturing Practice requirements administered under the country's cosmetics regulatory framework.
3. Who can benefit from ISO 22716 in China?
Chinese cosmetic manufacturers, OEM and ODM factories, private-label manufacturers, exporters, and international brands working with Chinese manufacturing partners can benefit from a structured ISO 22716 GMP approach.
4. How can MaxiCert help with ISO 22716 certification in China?
MaxiCert can support organizations with gap assessment, GMP documentation, implementation support, employee preparation, internal audit readiness, and preparation for the certification process.
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