Cosmetics GMP

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Standard Overview

ISO 22716 is a guideline for Good Manufacturing Practices (GMP) in the cosmetics manufacturing industry. It covers all activities on the cosmetics manufacturing floor, including personnel, premises, equipment, raw materials, production, finished products, quality control, and waste handling.

Why is it needed?

Compliance with ISO 22716 is mandatory when registering cosmetics in Europe (CPNP), and major export markets such as the US and Japan also adopt it as a standard. If your goal is to export cosmetics, it is not optional but essential. It is more than 90% similar to the MFDS CGMP, allowing integrated management.

Key Features

Manufacturing Environment

Establishes workplace and equipment hygiene standards to prevent cross-contamination.

Raw Material Management

Rigorously inspects raw materials and packaging from receipt to release.

Process Control

Manages the key parameters of manufacturing, filling, and packaging processes.

Deviation Management

Establishes handling and recurrence-prevention measures for out-of-spec products.

Certification Process

Current-State Diagnosis

Diagnose manufacturing facilities and hygiene standards

Documentation

Prepare the 4 core documents (manufacturing/quality/hygiene/premises)

Implementation

Manufacturing hygiene management and record-keeping

Certification Audit

Audit of GMP compliance on the manufacturing floor

Certification

Earn the essential passport for cosmetics exports

Expected Benefits

Export

Export Essential

Meet entry requirements for advanced cosmetics markets such as Europe and the US

Trust

Credibility

Assure overseas buyers and consumers of product safety

Upgrade

Quality Improvement

Reduce claims and level up quality through systematic quality management

Brand

Position your brand as one with world-class manufacturing facilities

Frequently Asked Questions

What is the difference between ISO 22716 and the MFDS CGMP?

ISO 22716 is a cosmetics GMP guideline established by the International Organization for Standardization (ISO), while the MFDS CGMP is Korea's Cosmetics Good Manufacturing and Quality Control Practice set by the Ministry of Food and Drug Safety. The two standards are roughly 90% or more similar, so preparing for them at the same time is efficient. The MFDS CGMP is required for domestic sales, and ISO 22716 is required for overseas exports.

Is ISO 22716 certification important for OEM/ODM cosmetics manufacturers?

It is very important. Global cosmetics brands often require ISO 22716 certification as a mandatory condition when selecting suppliers. In particular, when filing with the EU's CPNP (Cosmetic Products Notification Portal), GMP-based manufacturing evidence is required to comply with EU Regulation 1223/2009, and ISO 22716 is the fastest way to meet this requirement.

Which items most frequently receive non-conformity findings in an ISO 22716 audit?

Major non-conformity items include: (1) inadequate cross-contamination prevention facilities, (2) insufficient raw-material quality inspection records, (3) inadequate manufacturing deviation handling procedures, (4) lack of cleaning and sanitization management for consumables and tools, and (5) insufficient environmental monitoring records. Just Verify auditors improve these in advance through a preliminary diagnosis.

Do K-beauty indie brands also need to obtain ISO 22716?

Brands that do not sell overseas directly and instead outsource to domestic OEM factories can rely on the manufacturer's certification. However, if you export directly under your own brand or run cross-border e-commerce, ISO 22716 certification is necessary. In addition, a growing number of indie brands obtain it proactively to enhance brand credibility.

What are the validity period and renewal requirements for cosmetics ISO 22716 certification?

ISO 22716 certification is generally valid for 3 years, with an annual periodic surveillance audit to confirm that the system is being maintained. When significant changes occur—such as changes to manufacturing lines or the addition of new product categories—an additional audit may be required.

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