ISO 22716 Cosmetic GMP Explained: What It Covers and What to Ask a Factory

ISO 22716 is the international guideline for Good Manufacturing Practice (GMP) in the cosmetics industry. It describes how a factory should organise people, premises, equipment, materials, production, quality control, storage and records so that every batch is made consistently and safely. Brands use it as a common yardstick when comparing cosmetic manufacturers.

This article explains ISO 22716 cosmetic GMP in plain language: what it is, what it covers, how it differs from ISO 9001, and what to ask a factory to show you. MPC Innovation Lab operates under ISO 22716:2007 alongside ISO 9001:2015 and CODEX GHPs.

What is ISO 22716?

ISO 22716 is a guideline published by the International Organization for Standardization that sets out Good Manufacturing Practice for cosmetic products. GMP means a set of rules for running a production site so that quality is built into the process, rather than checked only at the end.

The standard covers the full chain inside the factory, from receiving raw materials to storing and shipping finished goods. It focuses on how work is done and recorded. It does not tell a brand which ingredients to use or promise that a product will perform in a particular way.

What does ISO 22716 cover?

At a high level, the guideline addresses these areas:

• Personnel: defined responsibilities, training, hygiene and protective clothing.
• Premises: layout, cleanliness, pest control and separation of areas to limit mix-ups and contamination.
• Equipment: suitable design, cleaning, maintenance and calibration of instruments.
• Raw materials and packaging materials: approval, receipt, labelling, storage and status (for example quarantined, approved or rejected).
• Production: written procedures, batch records, line clearance and control of in-process steps.
• Finished products: release rules and storage before shipment.
• Quality control laboratory: testing, sampling, specifications and handling of results that fall outside limits.
• Traceability: the ability to track which materials went into which batch and where the batch was shipped.
• Complaints and recalls: a system to record customer complaints and to act if a product must be withdrawn.
• Documentation: controlled procedures and records, so that what happened can be shown afterwards.

How is ISO 22716 different from ISO 9001?

ISO 9001 is a general quality management system standard that can apply to any organisation, in any industry. ISO 22716 is specific to cosmetics and describes practical manufacturing controls such as hygiene, cross-contamination, batch traceability and recalls.

They complement each other. ISO 9001 shows that a company manages processes, customer requirements and continual improvement in an organised way. ISO 22716 shows that the shop floor itself follows cosmetic-specific good practice. A cosmetic factory that holds both gives brands more confidence than one that holds only a general management certificate.

Why does GMP matter to a brand?

As the brand owner, your name is on the label, so consistency matters to you even though you do not run the line. GMP helps reduce the chance of contamination, mix-ups, wrong materials and undocumented changes. It also means that if a problem is reported, the factory can trace the batch and investigate.

GMP does not replace product-specific work such as stability testing, safety assessment and meeting labelling rules. Those still need to be planned for each product.

What should a brand ask a factory to show?

Do not stop at the certificate. Use this checklist when you audit a factory or request a visit:

• The ISO 22716 certificate, its scope (does it cover the product type you want?) and its validity date.
• A walk through the production area, looking at cleanliness, area separation and how materials are labelled.
• Raw material handling: how materials are received, identified and stored by status.
• A sample batch record, showing what is written down for each batch.
• The QC process: what is tested on incoming materials, in process and on finished goods.
• Traceability: ask them to trace a recent batch back to its raw material lots.
• The complaint and recall procedure.
• Staff training records and hygiene rules.

A confident factory will usually be happy to show these. Hesitation is a signal to ask more questions.

How does MPC Innovation Lab apply these standards?

MPC Innovation Lab is a one-stop OEM/ODM cosmetic factory in Krathum Baen, Samut Sakhon. We work under ISO 9001:2015, ISO 22716:2007 (Cosmetic GMP) and CODEX GHPs. Our process runs from brief and concept to formula, sample, confirmation, packaging and artwork, production, QC and delivery, so each stage is documented and reviewed. Brands are welcome to ask about our standards and arrange a visit.

For Thai FDA registration or notification requirements, which can change, please confirm current rules with the Thai FDA or with MPC's documentation team.