For cosmetic manufacturers, the ISO 22716 guideline is the most important standard to comply with. ISO 22716 is the international guideline for Good Manufacturing Practices, or GMP, for cosmetics.
What does ISO 22716 include?
In plain terms, it sets out how cosmetic products should be produced, controlled, stored, and shipped so quality is managed consistently. ISO itself is clear about the scope: the standard covers production, control, storage, and shipment of cosmetic products, and it does not cover personnel safety, environmental protection, research and development, or finished-product distribution.
For cosmetics manufacturers today, ISO 22716 has become a practical benchmark, as regulators, importers, retailers, and other stakeholders increasingly value credible, well-controlled manufacturing facilities.
ISO 22716 General Requirements
Here’s a practical ISO 22716 requirements covering production, control, storage, and shipment of cosmetic products.
| Area | Detailed ISO 22716 standard requirement | Evidence required |
| Quality management / GMP system | The site should run under a defined GMP system that consistently delivers product meeting defined quality characteristics. Roles, responsibilities, controls, and review mechanisms should be clear and documented. | Quality manual or equivalent, org chart, GMP policy, management responsibility matrix, site procedures, review records. |
| Personnel | Staff involved in production, control, storage, and shipment should be competent for their roles through training, experience, or both. Hygiene expectations should be defined and enforced. | Job descriptions, GMP training records, onboarding matrix, refresher training logs, hygiene/gowning rules, visitor/contractor controls. |
| Premises | Buildings and rooms should be suitable in size, layout, and condition to allow orderly operations, cleaning, maintenance, and prevention of mix-ups or contamination. Environmental conditions should be controlled where they matter to product quality. | Facility layout, zoning/flow diagrams, cleaning schedules, maintenance logs, pest control records, temp/humidity monitoring where relevant. |
| Equipment | Equipment and utensils should be designed, installed, maintained, cleaned, and, where needed, calibrated so they do not contaminate product or create quality drift. | Equipment list, preventive maintenance, cleaning SOPs, cleaning logs, calibration certificates, use-status labels. |
| Raw materials | Raw materials should be approved, identified, stored correctly, protected from contamination or deterioration, and prevented from accidental use before release. Rejected material should be controlled. | Approved supplier list, receiving checks, material specs, COAs, quarantine/release/reject labels, sampling and inspection records. |
| Packaging materials | Primary and other packaging materials should be handled with the same control discipline as raw materials so identity errors, contamination, and mix-ups are prevented. | Packaging specs, approved artwork/version control, line clearance records, label reconciliation, storage segregation. |
| Production control | Manufacturing steps should follow written instructions. In-process checks, weighing, measuring, line identification, and cleanliness controls should be built into the operation. Only approved materials should be used. | Master formula / manufacturing instructions, batch manufacturing records, second-person verification, line clearance, in-process check sheets, status labels on tanks and lines. |
| Prevention of mix-ups and contamination | The system should actively reduce the risk of wrong material use, wrong labeling, carryover, foreign matter, microbial contamination, and cross-contact through layout, cleaning, identification, and process discipline. | Cleaning validation or justification, campaign planning where relevant, segregation controls, closed containers, area clearance, incident history and CAPA. |
| Water and utilities | Water used as an ingredient or process utility should meet defined quality requirements and be monitored at an appropriate frequency. | Water specifications, test plans, microbiological and chemical results, sanitization or maintenance records for water systems. |
| Finished products | Finished products should meet defined acceptance criteria before release. Distribution arrangements should preserve quality through shelf life and allow traceability. | Finished product specifications, release records, retention samples, shipping/storage conditions, distribution traceability logs. |
| Quality control laboratory | Testing and inspection should be suitable to verify identity, conformance to specs, and control of microbiological or chemical risks as appropriate. | Test methods, sampling plans, retained sample program, lab records, OOS investigations, method suitability where applicable. |
| Out-of-specification / nonconforming product | Materials or products that fail requirements should be clearly identified, segregated, investigated, and controlled so they are not used or released by mistake. Rework or reprocessing should be justified and documented. | OOS forms, hold/reject logs, investigation reports, disposition approvals, rework records, CAPA. |
| Waste | Waste should be handled, stored, and removed in a way that does not create contamination, confusion, or housekeeping failures that affect product quality. | Waste procedures, labeled waste containers, removal logs, housekeeping checks. |
| Subcontracting / outsourced activities | Contracted activities that affect product quality should be clearly defined, controlled, and monitored. Responsibilities between the manufacturer and contractor should be formalized. | Quality or technical agreements, contractor qualification, audit records, incoming acceptance criteria, oversight records. |
| Deviations | Unexpected events, process departures, errors, or abnormal results should be documented, assessed for impact, investigated, and followed by corrective action. | Deviation reports, impact assessments, root-cause analysis, CAPA tracking, effectiveness checks. |
| Complaints and recalls | Complaints should be logged and assessed for severity, trend, and possible product defect. There should be a recall or market action process that is fast, documented, and traceable. | Complaint files, adverse event intake, trend analysis, recall SOP, mock recall records, contact lists, investigation outcomes. |
| Change control | Changes that could affect product quality, consistency, labeling, or compliance should be reviewed before implementation and documented with appropriate approvals. | Change control forms, risk assessments, validation/verification of change, updated specs/SOPs/artwork, approval signatures. |
| Internal audit | The company should periodically examine whether the GMP system is actually being followed and remains effective. Findings should lead to corrective action. | Internal audit schedule, checklists, reports, nonconformity log, CAPA closure evidence. |
| Documentation and records | Procedures and records should be controlled, legible, current, retrievable, and sufficient to reconstruct what happened to a batch, material, complaint, or change. | Document control procedure, revision history, batch files, training records, release records, archival/retention controls. |
| Labeling and traceability | Labels should be controlled to prevent wrong-product/wrong-version use, and batches should be traceable through manufacture and distribution. | Label issuance and reconciliation, coded batch numbering, shipment logs, traceability exercises, artwork approval records. |
Is ISO 22716 Mandatory in the United States?
Not as a standalone standard. The FDA’s current public materials still describe cosmetics GMP through guidance and ongoing rulemaking under MoCRA, the Modernization of Cosmetics Regulation Act. FDA says MoCRA requires it to establish GMP requirements for cosmetic product facilities, and FDA’s current GMP materials state that rigorous adherence to GMP helps minimize adulteration or misbranding. FDA has also said, in its draft cosmetics GMP guidance, that it reviewed ISO 22716 and decided whether to incorporate, modify, or exclude specific aspects of that standard when updating its guidance.
So the clean read for the U.S. is this; ISO 22716 certification itself is not the law, but FDA is not ignoring it either. The agency has explicitly engaged with ISO 22716 while shaping modern cosmetics GMP expectations. Any U.S. manufacturer that wants to be taken seriously by regulators, investors, retailers, or global customers should stop asking whether ISO 22716 is “technically required” and start asking whether they can defend their GMP system without it. That is the smarter question.
Should Cosmetics Manufacturers Pursue ISO 22716?
If you are a contract manufacturer, a fast-growing indie brand using third-party production, an exporter, or a facility that wants retailer-ready systems, ISO 22716 is worth treating as a strategic baseline. It gives management discipline, cleaner documentation, stronger audit readiness, and a more credible story when buyers or regulators start asking hard questions.
If you are a very small local operation with limited distribution, the immediate move may not be certification first. The better move may be to build your system to ISO 22716 principles now, close the obvious gaps, and then decide when certification makes commercial sense. But ignoring the framework entirely would be poor judgment.
Get a 22716 Assessment With CGA
If your facility manufactures cosmetics, personal care products, or contract-manufactured beauty products, a 22716 assessment with CGA can help you understand where your GMP system stands before gaps become regulatory, customer, or retailer problems.
Get in touch with an expert by emailing us at admin@caratga.com or calling +1 813 906 8113.
Frequently Asked Questions (FAQs)
Not everywhere. The standard itself is a guideline. But in the EU, compliance with cosmetic GMP is legally required, and ISO 22716 is the recognized harmonized standard used to demonstrate that conformity.
Not as a blanket legal requirement. But FDA has explicitly considered ISO 22716 in its cosmetics GMP guidance work, and MoCRA requires FDA to establish cosmetics GMP requirements.
No. GMP expectations apply across the sector, and smaller manufacturers are not exempt from the need for controlled processes just because they are smaller. FDA’s public GMP discussion even addressed flexibility for facilities of different sizes and types.
No. It supports controlled manufacturing, but it does not replace broader safety, legal, and market-specific compliance obligations.
Can’t find what you’re looking for?
