ISO 22716:2007
Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices
Standard Introduction
ISO 22716:2007 is an published — confirmed in 2022 standard published by International Organization for Standardization (ISO). It is commonly used across Cosmetics & Skincare, Manufacturing, Retail, Chemical & Materials and applies in Global, European Union, European Economic Area, United Kingdom.
Use this page to review the official documentation, current status, and the certification or assessment bodies most commonly associated with ISO 22716:2007.
Cosmetics Manufacturing GMP
Covers the quality practices used in the production, control, storage and shipment of cosmetic products, including skincare products.
International Baseline
A voluntary international standard that is also used as a regulatory GMP reference in markets including the EU and Great Britain.
Lifecycle Evidence
Turns facilities, people, materials, equipment, production, quality control, complaints, recalls and documentation into an auditable operating system.
list_alt Implementation Focus
- Personnel roles, hygiene and training
- Suitable premises and contamination controls
- Qualified equipment and maintenance
- Controlled raw-material and packaging receipt
- Documented production and packaging operations
- Quality-control sampling, testing and release
- Deviation, complaint, return and recall handling
- Change control, internal audit and document retention
Who Needs to Comply?
Cosmetic and skincare manufacturers, contract manufacturers, fillers, packers, quality-control laboratories and brand owners that need a controlled manufacturing process or evidence of cosmetic GMP for a target market. The standard does not cover research and development or distribution of finished products.
Key Requirements
Control People and Premises
Define responsibilities, train personnel and maintain hygienic, orderly premises designed to reduce mix-ups and contamination.
Control Materials and Equipment
Approve suppliers and specifications, identify and store materials appropriately, and keep production and test equipment suitable, clean and maintained.
Control Production and Release
Use approved instructions, batch identification, in-process controls, sampling, testing and authorized release so each lot is traceable.
Control Problems and Change
Investigate deviations, out-of-specification results, complaints and returns; manage changes, corrective actions and recalls with documented decisions.
Keep Verifiable Records
Maintain current procedures, specifications, batch records, test results, training, cleaning, maintenance and audit evidence for the required retention period.
Implementation Roadmap
Confirm scope and market obligations
Map every manufacturing, filling, packing, testing, storage and shipment activity; identify legal GMP obligations by target market; assign quality authority and product-release responsibility.
Build the controlled operating system
Approve personnel, hygiene, premises, equipment, material, production, quality-control, subcontracting and documentation procedures. Establish specifications, status controls and batch traceability.
Qualify and generate evidence
Train personnel, qualify suppliers and equipment, verify cleaning and water controls, execute representative batches and confirm that quality-control methods and release records work as designed.
Audit, correct and sustain
Run internal audits, investigate deviations and complaints, test recall traceability, trend quality data and control changes. Keep the system current when formulas, suppliers, equipment, sites or market rules change.
Compliance Checklist
checklist People, premises and equipment
checklist Materials and production
checklist Quality and release
checklist Post-production and assurance
Cosmetic Quality Standards: Which One Does What?
These standards answer different questions and are commonly used together for skincare products.
| Standard | Primary question | Typical evidence | Boundary |
|---|---|---|---|
| ISO 22716:2007 | Is the product manufactured under controlled cosmetic GMP? | Procedures, batch records, release, deviations, complaints, audits | Manufacturing quality system; not a complete safety assessment |
| ISO 11930:2019 | Is antimicrobial protection adequate during intended use? | Risk assessment or challenge-test protocol, data and conclusion | Preservation efficacy; not general GMP |
| ISO 17516:2014 | Does finished-product microbiological quality meet justified limits? | Risk classification, methods and release results | Microbiological limits; Edition 2 is in publication |
| ISO 22715:2006 | Is cosmetic packaging and labelling structured to the standard? | Approved artwork and label review | Does not replace national labelling law |
Common Misconceptions
An ISO 22716 certificate means a skincare product is approved for sale worldwide.
The standard addresses manufacturing GMP. Each market still applies its own responsible-person, safety, ingredient, notification, claims and labelling rules.
A brand can outsource GMP responsibility completely to its contract manufacturer.
Manufacturing may be outsourced, but the brand or legally responsible person still needs defined oversight, agreements and evidence that the product is made and released under appropriate controls.
Passing finished-product tests is enough to demonstrate GMP.
GMP depends on controlled people, facilities, materials, processes, records and problem handling. End-product testing alone cannot prove that the process remained controlled.
Penalties & Enforcement
ISO 22716 is voluntary and ISO does not certify organizations. Consequences arise from the applicable market law or contract. In the EU, cosmetic manufacture must follow GMP and EN ISO 22716 provides a presumption of conformity; regulators may restrict, withdraw or recall non-compliant products under the cosmetics regime.
Frequently Asked Questions
Is ISO 22716 mandatory for skincare manufacturers?
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ISO 22716 is a voluntary international standard, but target-market law can make cosmetic GMP mandatory or give the standard a specific legal role. In the EU, Article 8 of Regulation (EC) No 1223/2009 requires GMP and compliance is presumed when manufacture follows the cited harmonised standard EN ISO 22716:2007. Great Britain also recognizes ISO 22716 as a way to demonstrate cosmetic GMP.
Can a company be ISO 22716 certified?
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Third parties may audit or certify against ISO 22716, but ISO itself does not certify organizations and the standard does not require a certificate. A certificate does not replace product safety, notification, responsible-person, labelling or other market-specific duties.
Does ISO 22716 cover product safety testing?
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It covers the quality aspects of production, control, storage and shipment. ISO's scope says it does not, as a whole, cover plant-personnel safety or environmental protection. It also does not replace the cosmetic safety assessment, ingredient restrictions, microbiological risk assessment, preservation efficacy testing or market-specific substantiation requirements.
Does ISO 22716 apply to research and development?
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No. ISO's published scope states that the guidelines do not apply to research and development activities or to distribution of finished products. Technology transfer into routine manufacture and the manufacturing, storage and shipment controls are within the practical GMP boundary.
What evidence should a skincare brand request from a contract manufacturer?
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Request the site's GMP scope, current audit evidence, quality agreement, responsible roles, material and supplier controls, batch and release records, deviation and change controls, complaint and recall process, subcontractor controls and records showing that the specific product and site are covered.
Does ISO 22716 by itself satisfy U.S. MoCRA GMP requirements?
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No. As of 20 October 2026, FDA states that it has no final cosmetic GMP regulation and that MoCRA requires FDA to establish one. ISO 22716 can support a quality system, but it does not replace current U.S. statutory duties or a future final FDA GMP rule. U.S. facilities should monitor FDA rulemaking and separately address registration, product listing, safety substantiation, adverse-event reporting and records obligations.
Official Documentation
Official PDF for ISO 22716:2007
Official publication or summary for ISO 22716:2007
Official online resource
International Organization for Standardization (ISO) guidance and reference material
Implementation toolkit
Templates, guidance, or companion resources for ISO 22716:2007