Cosmetics GMP Consultant | Certify Consulting

Regulatory Compliance

Cosmetics GMP Compliance

Good Manufacturing Practices are no longer optional for cosmetics companies operating in the U.S. market.

The FDA's Modernization of Cosmetics Regulation Act (MoCRA) of 2022 represents the most significant update to U.S. cosmetics regulation in over 80 years. For the first time, FDA now requires cosmetics manufacturers to register facilities, list products, report adverse events, and comply with Good Manufacturing Practice requirements.

ISO 22716 is the internationally recognized GMP standard specifically designed for the cosmetics industry. It provides comprehensive guidelines for the production, control, storage, and shipment of cosmetic products. ISO 22716 is referenced by the EU Cosmetics Regulation and increasingly recognized by FDA as a benchmark for cosmetics GMP compliance.

Whether you need to meet MoCRA requirements, achieve ISO 22716 certification, or satisfy international regulatory demands, our experienced consultants guide you through every step of the process. We help you build a GMP system that is practical, sustainable, and audit-ready.

Why Cosmetics GMP Matters Now

MoCRA mandate — FDA now requires GMP compliance for all cosmetics manufacturers
Consumer safety — Protect your customers with consistent, controlled manufacturing
Market access — ISO 22716 certification opens doors to EU and global markets
Retailer requirements — Major retailers increasingly require GMP compliance from suppliers
Brand protection — Reduce recall risk and build trust through certified quality

What We Offer

Our Cosmetics Services

Comprehensive GMP consulting tailored to the cosmetics industry, from ISO 22716 certification to FDA MoCRA compliance.

ISO 22716 Certification

The international GMP standard for cosmetics. We guide you through every requirement — from personnel and premises to production and quality control — to achieve certification.

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FDA MoCRA Compliance

Navigate the new FDA requirements under the Modernization of Cosmetics Regulation Act. We help with facility registration, product listing, adverse event reporting systems, and GMP compliance documentation.

GMP Documentation

Complete documentation packages tailored to cosmetics manufacturing — standard operating procedures (SOPs), batch production records, specification sheets, cleaning and sanitation protocols, and revision-controlled document systems.

Quality System Development

Build a robust quality management system for your cosmetics operation. CAPA (Corrective and Preventive Actions), complaint handling, supplier qualification programs, change control, and management review processes.

Industries We Serve

Who Needs Cosmetics GMP?

If you manufacture, process, or distribute cosmetics products, GMP compliance is essential for regulatory compliance and market access.

Cosmetics Manufacturers

Companies producing makeup, skincare, hair care, fragrances, and personal care products

Skincare & Beauty Brands

Brands developing and marketing skincare, beauty, and personal care product lines

Contract Manufacturers

Third-party manufacturers producing cosmetics on behalf of brand owners and distributors

Private Label Brands

Companies selling cosmetics under their own brand, manufactured by third parties

Raw Material Suppliers

Suppliers of cosmetic ingredients, raw materials, and packaging components

Importers & Distributors

Companies importing or distributing cosmetics products in the U.S. and international markets

Our Proven Process

Our 8-Step Approach

A structured methodology adapted for cosmetics GMP — from initial assessment through certification and ongoing compliance.

1

Gap Assessment

Comprehensive evaluation of your current practices against ISO 22716 and MoCRA GMP requirements. We identify gaps and build a prioritized action plan.

2

GMP Documentation

Develop all required GMP documents — quality manual, SOPs, batch records, specifications, cleaning protocols, and document control systems.

3

Process Validation

Validate manufacturing processes, cleaning procedures, and analytical methods to demonstrate consistent product quality and safety.

4

Facility & Equipment

Qualify your facility layout, equipment, and utilities. Ensure premises meet GMP requirements for production, storage, and quality control areas.

5

Staff Training

GMP awareness and role-specific training for all personnel. Covers hygiene, documentation practices, contamination prevention, and quality responsibilities.

6

Quality Controls

Implement in-process controls, finished product testing, stability programs, and release procedures to ensure every batch meets specifications.

7

Internal Audits

Conduct thorough internal audits to verify GMP compliance across all operations. Identify and resolve nonconformities before your certification audit.

8

Certification Readiness

Final preparation for your certification audit or FDA inspection. Mock audits, management review, and complete readiness verification.

Common Questions

Frequently Asked Questions

What is MoCRA and how does it affect cosmetics companies?

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 is the most significant update to FDA cosmetics regulation in decades. It requires cosmetics facility registration, product listing, adverse event reporting, and GMP compliance. All cosmetics manufacturers and processors marketing products in the U.S. must comply with MoCRA requirements, making GMP implementation essential for continued market access.

Is ISO 22716 mandatory for cosmetics?

ISO 22716 is not universally mandatory, but it is the internationally recognized GMP standard for cosmetics and is referenced by regulators worldwide. In the EU, ISO 22716 is the harmonized standard for cosmetics GMP compliance. In the U.S., FDA's MoCRA GMP requirements align closely with ISO 22716 principles. Many retailers and distributors also require ISO 22716 compliance from their suppliers.

What's the difference between cosmetics GMP and pharmaceutical GMP?

Cosmetics GMP (ISO 22716) and pharmaceutical GMP (cGMP per 21 CFR Parts 210/211) share core principles like documentation, process controls, and quality systems, but differ in scope and rigor. Pharmaceutical GMP requires formal process validation, stability testing, and stricter environmental controls. Cosmetics GMP focuses on production hygiene, personnel training, and product quality controls appropriate for cosmetic products. Companies making both cosmetics and OTC drugs may need to comply with both standards.

How long does it take to implement cosmetics GMP?

Most cosmetics companies can implement a compliant GMP system within 3 to 6 months, depending on company size, existing quality systems, and product complexity. Companies with some quality infrastructure in place can often achieve compliance faster. Our structured 8-step process keeps the timeline predictable and minimizes disruption to your operations.

Ready to Achieve Cosmetics GMP Compliance?

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

Schedule Free Consultation Call 858-240-4353

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