ISO 22716 Consultant | Certify Consulting

The Standard

What is ISO 22716?

The internationally recognized good manufacturing practice standard designed specifically for the cosmetics industry.

ISO 22716:2007 — Cosmetics: Good Manufacturing Practices (GMP) provides comprehensive guidelines for the production, control, storage, and shipment of cosmetic products. It is the global benchmark for cosmetics manufacturing quality and is recognized by regulatory authorities worldwide.

The standard covers every aspect of cosmetics manufacturing operations — from personnel qualifications and training to premises and equipment requirements, from raw material management to finished product release. It establishes a framework for quality management that ensures products are consistently produced and controlled to the quality standards appropriate for their intended use.

ISO 22716 is referenced by the EU Cosmetics Regulation (EC 1223/2009) as the harmonized standard for demonstrating GMP compliance. It is also increasingly recognized by FDA as a benchmark for cosmetics GMP under the new MoCRA requirements.

Achieving ISO 22716 certification demonstrates your commitment to product quality and consumer safety, strengthens regulatory compliance, and opens doors to international markets.

ISO 22716 at a Glance

Full title: ISO 22716:2007 — Cosmetics: Good Manufacturing Practices (GMP)
Scope: Production, control, storage, and shipment of cosmetic products
Recognition: Referenced by EU Cosmetics Regulation and aligned with FDA MoCRA
Applies to: All organizations involved in cosmetic product manufacturing
Benefit: Global market access, regulatory compliance, consumer safety assurance

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Standard Requirements

ISO 22716 Key Requirements

The standard addresses eight core areas that together form a comprehensive cosmetics GMP system.

Personnel & Training

Organizational structure, responsibilities, competency requirements, hygiene practices, and ongoing training programs for all staff involved in cosmetics manufacturing.

Premises & Facilities

Facility design, construction, layout, and maintenance. Production areas, storage zones, quality control laboratories, and environmental controls.

Equipment

Equipment design, installation, calibration, maintenance, and cleaning. Ensuring equipment is fit for purpose and does not contaminate products.

Raw Materials & Packaging

Purchasing, receiving, identification, storage, and release of raw materials and packaging materials. Supplier qualification and incoming quality checks.

Production

Manufacturing operations, in-process controls, batch numbering, traceability, and procedures for handling deviations during the production process.

Finished Products

Finished product storage, release criteria, shipment controls, and procedures to ensure only conforming products reach the market.

Quality Control Laboratory

Laboratory testing methods, sampling procedures, reference standards, out-of-specification investigations, and retained sample programs.

Documentation & Records

Document control systems, record keeping, batch documentation, change control, and procedures for creating, reviewing, approving, and archiving GMP documents.

Our Proven Process

Our ISO 22716 Process

A structured 8-step methodology specifically adapted for ISO 22716 cosmetics GMP certification.

1

ISO 22716 Gap Analysis

Evaluate your current operations against every clause of ISO 22716. Identify gaps in personnel, premises, equipment, materials, production, QC, and documentation.

2

GMP Documentation

Develop your complete ISO 22716 documentation system — quality manual, SOPs, batch records, specifications, cleaning protocols, and document control procedures.

3

Process Validation

Validate your manufacturing, cleaning, and analytical processes. Demonstrate that your operations consistently produce products meeting defined specifications.

4

Premises & Equipment

Qualify your facility, equipment, and utilities against ISO 22716 requirements. Address layout, material flow, environmental controls, and equipment maintenance.

5

Personnel Training

ISO 22716 awareness and GMP training for all personnel. Covers hygiene, documentation practices, contamination control, and role-specific responsibilities.

6

Quality Controls

Implement quality control systems per ISO 22716 — incoming material testing, in-process checks, finished product release, and stability monitoring programs.

7

Internal Audits

Conduct comprehensive internal audits against ISO 22716. Identify nonconformities, implement corrections, and verify effectiveness before your certification audit.

8

Certification Readiness

Final preparation including mock certification audits, management review, and complete system verification. Go into your audit with confidence and zero surprises.

Regulatory Alignment

ISO 22716 and MoCRA

How ISO 22716 certification positions your company for FDA MoCRA compliance and global market access.

The FDA's Modernization of Cosmetics Regulation Act (MoCRA) requires cosmetics manufacturers to follow Good Manufacturing Practices. While FDA has not formally adopted ISO 22716 as its GMP standard, the principles and requirements of ISO 22716 align closely with what MoCRA expects from cosmetics manufacturers.

Companies that have already implemented ISO 22716 are well-positioned for MoCRA compliance. The standard's requirements for documentation, quality control, personnel training, facility management, and production controls address the core GMP expectations that FDA will enforce under MoCRA.

By pursuing ISO 22716 certification, you are not only meeting international cosmetics GMP requirements but also building a solid foundation for U.S. regulatory compliance — giving your company a competitive advantage in both domestic and international markets.

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Facility Registration

ISO 22716 premises requirements align with MoCRA's facility registration and GMP expectations.

Adverse Event Reporting

ISO 22716 complaint handling and deviation systems provide the foundation for MoCRA adverse event reporting.

Product Safety & Labeling

ISO 22716 quality controls and documentation support MoCRA product listing and safety substantiation requirements.

EU Market Access

ISO 22716 is the EU-harmonized cosmetics GMP standard — one certification serves both U.S. and EU compliance needs.

Common Questions

Frequently Asked Questions

What is the scope of ISO 22716?

ISO 22716 covers the guidelines for good manufacturing practices for cosmetic products. Its scope includes production, control, storage, and shipment of cosmetic products. The standard addresses personnel, premises, equipment, raw materials and packaging materials, production, finished products, quality control laboratory, treatment of out-of-specification products, waste, subcontracting, deviations, complaints and recalls, change control, internal audit, and documentation. It applies to all organizations involved in the manufacturing of cosmetic products.

Is ISO 22716 certification mandatory?

ISO 22716 certification is not universally mandatory, but it is increasingly expected by regulators and business partners. In the EU, ISO 22716 is the harmonized standard referenced by the EU Cosmetics Regulation (EC 1223/2009) for demonstrating GMP compliance. In the U.S., ISO 22716 aligns closely with FDA MoCRA GMP requirements. Many major retailers, distributors, and brand owners require their suppliers to hold ISO 22716 certification as a condition of doing business.

How does ISO 22716 differ from cGMP?

ISO 22716 is specifically designed for the cosmetics industry, while cGMP (current Good Manufacturing Practice) typically refers to FDA pharmaceutical regulations under 21 CFR Parts 210 and 211. ISO 22716 focuses on cosmetics-appropriate controls including production hygiene, personnel training, and quality systems proportionate to cosmetic product risk. Pharmaceutical cGMP requires more rigorous process validation, stability testing, environmental monitoring, and analytical method validation. Both share foundational principles of documentation, quality control, and traceability, but the level of rigor differs based on product risk classification.

Can ISO 22716 help with EU cosmetics regulation compliance?

Yes, ISO 22716 is directly referenced by the EU Cosmetics Regulation (EC 1223/2009) as the harmonized standard for demonstrating GMP compliance. Article 8 of the regulation requires that cosmetics be manufactured in accordance with GMP, and ISO 22716 is presumed to satisfy this requirement. Companies holding ISO 22716 certification can demonstrate EU GMP compliance more easily during regulatory inspections and when preparing Product Information Files (PIFs) for the EU market.

Ready to Get ISO 22716 Certified?

Schedule a free 30-minute consultation. We'll assess your current cosmetics GMP status, outline a clear path to ISO 22716 certification, and answer all your questions — no obligation.

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ISO 22716 Cosmetics GMP