For skincare brands and importers, ISO 22716 and FDA GMP are the two most commonly mentioned terms among numerous certifications, and choosing a manufacturer that meets these international standards is key to ensuring product safety and smooth access to global markets. But what exactly do these two certifications mean, and which is more important for your brand?
This article provides an in-depth analysis of their core differences, scope of application, and commercial value, helping you make a more informed decision when selecting a manufacturing partner.
Quick Comparison
Before diving into the details, the table below highlights the key differences between ISO 22716 and FDA GMP:
| Comparison Criteria | ISO 22716 | FDA GMP |
| Nature | International voluntary standard | U.S. regulatory requirements (non-mandatory guidelines) |
| Issuing Body | International Organization for Standardization (ISO) | U.S. Food and Drug Administration (FDA) |
| Scope of Application | Globally applicable | Mainly targeting the US market |
| Core Content | Guidelines for Good Manufacturing Practice for Cosmetics | Guidance for Cosmetic Good Manufacturing Practice Inspections |
| Legal Effect | Certification standard, third-party certification available | Regulatory requirements, FDA may inspect implementation. |
| Market Recognition | Adopted by more than 140 countries, including the EU and ASEAN. | Foundation for US market access |
| Relationship with MoCRA | Adopted as the GMP standard by many countries. | MoCRA requires compliance with GMP regulations. |
Ⅰ.What is ISO 22716?
ISO 22716 is the Good Manufacturing Practice (GMP) guideline for cosmetics issued by the International Organization for Standardization. It provides the cosmetics industry with a complete quality management framework from raw material procurement to finished product distribution. This standard covers all aspects including personnel, premises, equipment, raw materials, production, quality control, packaging, storage and distribution.
Core Features of ISO 22716
1.International Applicability
ISO 22716 is the cosmetic GMP standard recognized by more than 140 countries worldwide. The EU designated it as the officially required cosmetic GMP standard as early as 2013, and ASEAN also regards ISO 22716 as an equivalent document complying with its GMP guidelines.
2. Systematic Framework
ISO 22716 is not merely a checklist but a complete management system. It emphasizes how to organize and control the manufacturing process, rather than a series of simple pass/fail tests. This includes:
- Personnel and Training: Clear role allocation, requiring targeted training and proof of competence.
- Premises and Environment: Control of personnel and material flow to prevent mix-ups and cross-contamination.
- Equipment and Maintenance: Definition of the equipment lifecycle and maintenance of calibration status.
- Raw Material Management: Implementation of supplier control, incoming material inspection, and release procedures.
- Production Control: Full process control from weighing, mixing to filling.
- Quality Control: Laboratory testing, stability studies, and retention sample management.
3.Certifiability
Unlike FDA GMP, ISO 22716 can be audited and certified by third-party certification bodies. This provides enterprises with verifiable compliance proof and enhances trust among partners and consumers.
Commercial Value of ISO 22716
Obtaining ISO 22716 certification brings multiple advantages to enterprises:
- Ensures product safety: A systematic quality management system reduces product safety risks.
- Improves management level: Standardized processes enhance operational efficiency.
- Internationally recognized: Serves as a passport for international trade, helping products enter global markets.
- Enhances competitiveness: The certification itself provides strong endorsement for brand reputation.
II. What is FDA GMP?
FDA GMP refers to the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist for Cosmetics issued by the U.S. Food and Drug Administration (FDA).Originally published in 1997, this guideline was revised in 2008 and integrated relevant requirements from ISO 22716 in 2013.
Core Characteristics of FDA GMP
1. Regulatory Background
Under the Federal Food, Drug, and Cosmetic Act, it is prohibited to introduce adulterated or misbranded cosmetics into interstate commerce. Cosmetics may be considered adulterated if they:
- Contain harmful substances that may cause injury to users
- Contain filth or putrid substances
- Contain unapproved color additives
- Are manufactured or stored under unsanitary conditions
2. Nature of the Inspection Guidance
FDA GMP guidelines are essentially inspection checklists used by FDA inspectors during cosmetic facility inspections. They do not impose legally enforceable requirements and are regarded as recommendations.
However, this does not mean manufacturers can ignore them. Serious violations found during FDA inspections may still result in products being detained or refused entry into the U.S. market.
3. Key Inspection Points
The FDA GMP guidelines cover eight major areas:
- Buildings and Facilities: Inspection of plant design, cleaning and maintenance, lighting and ventilation, sanitary facilities, etc.
- Equipment: Inspection of equipment design, cleaning and disinfection, maintenance status, etc.
- Personnel: Inspection of personnel qualifications, hygiene practices, training, etc.
- Raw Materials: Inspection of raw material storage, labeling, sampling and testing, non-conforming material control, etc.
- Production: Inspection of manufacturing instructions, equipment cleaning, material verification, label management, etc.
- Laboratory Controls: Inspection of raw material and finished product testing, retention sample management, water quality testing, etc.
- Records: Inspection of records for raw materials, production, finished products, distribution, and other processes.
- Labeling: Inspection of whether the label information on the principal display panel and information panel complies with requirements.
FDA GMP and MoCRA
The Cosmetic Regulatory Modernization Act (MoCRA), enacted in 2022, represents the most significant reform of cosmetics regulation in the United States since 1938.
MoCRA explicitly requires cosmetic companies to comply with GMP regulations and grants the FDA greater enforcement authority.
This means that GMP compliance has shifted from recommended to mandatory.
III. Core Differences Between ISO 22716 and FDA GMP
1.Nature and Legal Status
ISO 22716 is an international voluntary standard, and enterprises may obtain certification through third-party bodies. FDA GMP guidelines are recommendatory in nature, but following the implementation of MoCRA, compliance with GMP has become a legal obligation for the U.S. market.
2.Scope of Application
ISO 22716 is adopted or recognized by more than 140 countries, including the EU, ASEAN, Japan, and South Korea, serving as a common standard for cosmetic exports worldwide. FDA GMP is mainly targeted at the U.S. market and acts as a guidance document for FDA inspectors.
3.Implementation Approach
ISO 22716 requires the establishment of a complete quality management system, including systematic elements such as document control, training matrices, deviation management, and corrective and preventive actions. FDA GMP guidelines focus more on checklist-based compliance requirements.
4.Data Integrity Requirements
ISO 22716 emphasizes the ALCOA+ principles for electronic records (Attributable, Legible, Contemporaneous, Original, Accurate), requiring audit trails, unique user logins, and controlled retention. The FDA also sets requirements for electronic records under 21 CFR Part 11, but these are less covered in the FDA GMP guidelines themselves.
5.Relationship with MoCRA
MoCRA mandates that companies comply with GMP regulations. Although the FDA has not yet issued its final GMP rule, ISO 22716 is widely regarded as a viable pathway to meet MoCRA GMP requirements. In fact, the content of ISO 22716 has already been integrated into the FDA’s GMP guidelines.
IV. New GMP Compliance Requirements Under the MoCRA Framework
The implementation of MoCRA brings new challenges and requirements for cosmetic GMP compliance.
1.Facility Registration and Product Listing
Under MoCRA, all facilities that manufacture or process cosmetics sold in the United States must register with the FDA and renew registration every two years. Meanwhile, each product must be listed.
2.Safety Substantiation
MoCRA requires responsible persons to maintain records sufficient to substantiate product safety, including:
- Toxicological Risk Assessment: Calculate Margin of Safety (MoS) and incorporate local regulatory requirements
- Clinical Safety Tests: HRIPT, skin irritation testing, etc.
- Analytical Testing: Testing for risky substances such as PFAS, heavy metals, 1,4-dioxane
- Microbiological Testing: Preservative Efficacy Testing
- Stability Evaluation: Real-time, accelerated and challenge testing
3.Adverse Event Reporting
Serious adverse events must be reported to the FDA within 15 business days, and an annual summary of adverse events must be submitted.
4.Mandatory Recall Authority
MoCRA grants the FDA statutory authority to initiate mandatory recalls of cosmetics for the first time.
V. Which One Is Most Important for Your Brand?
Back to the original question: ISO 22716 and FDA GMP — which is more important for your brand? The answer depends on your target market and stage of development.
If your target market is…
1. Focused on the U.S. Market
If you mainly target the United States, FDA GMP compliance is a mandatory regulatory requirement.
Following the implementation of MoCRA, FDA enforcement of GMP will be significantly strengthened.
Choosing a manufacturer with FDA registration and cGMP compliance can greatly reduce customs risks and compliance costs.
2. EU and Global Markets
If your products plan to enter global markets such as the EU, ASEAN, Japan, etc.,
ISO 22716 certification is the core market access credential.
The EU has mandated ISO 22716 for cosmetic manufacturers since 2013, and ASEAN also recognizes ISO 22716 as an equivalent standard.
3. Multi-Market Strategy
For brands aiming at the global market, the ideal choice is a manufacturer that complies with both ISO 22716 and FDA GMP.
The systematic framework of ISO 22716 can serve as a common foundation to meet GMP requirements in various countries.
How to Verify Manufacturer Compliance
Whichever certification you choose, it is critical to verify the manufacturer’s genuine compliance:
- Request official certificates: Ask for official documents such as ISO 22716 certificates, FDA registration numbers, etc.
- Verify certification bodies: Check if the certification body is authoritative and recognized (e.g., SGS, TÜV, etc.).
- Review audit reports: Request recent third-party audit reports.
- On-site or virtual visits: Inspect the factory’s actual operations and sanitary conditions.
Summary
ISO 22716 and FDA GMP are complementary compliance frameworks: the former serves as a universal passport to global markets, while the latter provides the regulatory foundation for accessing the U.S. market. For brands aiming for a global layout, the optimal choice is a manufacturer that meets both standards.
If you are looking for such a manufacturing partner, DESIFINE, with German management standards, GMPC and ISO 22716 certifications, and an FDA-registered factory, can provide solid support for your brand to enter the global market. Choosing a compliant partner is the most critical step toward brand success.
