Good Manufacturing Practice (ISO 22716)
What is Good Manufacturing Practice (ISO 22716)?
Good Manufacturing Practice (GMP) for cosmetics refers to the set of guidelines and controls governing the production, control, storage, and shipment of cosmetic products to ensure they are consistently manufactured to a quality appropriate for their intended use. Under Regulation (EC) No 1223/2009, compliance with GMP is a mandatory requirement for cosmetic products placed on the EU market. The internationally recognised standard for cosmetics GMP is ISO 22716, which provides detailed practical guidance on how GMP principles should be implemented.
Why It Matters
GMP compliance is not simply a quality management exercise — it is a legal obligation under the EU Cosmetics Regulation. The Responsible Person must include a declaration of compliance with GMP in the Product Information File for every cosmetic product placed on the EU market. Without evidence of GMP compliance, the PIF is incomplete and the product may be considered non-compliant.
Beyond regulatory compliance, GMP provides the operational framework that helps manufacturers produce safe and consistent cosmetic products. It reduces the risk of contamination, mix-ups, and errors that could lead to unsafe products reaching consumers, with potential consequences for both public health and brand reputation.
For cosmetic manufacturers, contract manufacturers, and brands managing their supply chain, understanding and implementing GMP in line with ISO 22716 is a fundamental part of EU cosmetics compliance.
Key Requirements
Who Is Required to Comply with GMP?
GMP compliance is required for all parties involved in the manufacture of cosmetic products placed on the EU market, including:
- Manufacturers producing cosmetic products for the EU market
- Contract manufacturers producing cosmetic products on behalf of a brand or Responsible Person
- Responsible Persons who must declare GMP compliance as part of the Product Information File
This requirement applies under:
- Regulation (EC) No 1223/2009 — EU Cosmetics Regulation, Article 8
- ISO 22716 — Cosmetics GMP Guidelines, the internationally recognised standard referenced by the regulation
What GMP Covers Under ISO 22716
ISO 22716 provides guidance across all key areas of cosmetic manufacturing, commonly including:
- Personnel — qualifications, hygiene, and training requirements
- Premises — design, maintenance, and cleanliness of manufacturing facilities
- Equipment — installation, maintenance, and cleaning of manufacturing equipment
- Raw materials and packaging — receipt, storage, and release procedures
- Production — manufacturing processes, in-process controls, and batch records
- Finished products — release procedures and quality checks before distribution
- Quality control — testing, documentation, and deviation management
- Waste management — disposal of waste materials in a controlled manner
- Subcontracting — requirements for managing third-party manufacturing relationships
- Documentation — record keeping and document control procedures
GMP and the Product Information File
The Responsible Person is required to include a description of the manufacturing method and a declaration of compliance with GMP in the Product Information File for each cosmetic product. This declaration confirms that the product has been manufactured in accordance with ISO 22716 or an equivalent GMP standard. Where manufacturing is carried out by a third party, the Responsible Person should obtain appropriate evidence of GMP compliance from the contract manufacturer.
Need EU cosmetics compliance support?
Euverify provides Responsible Person services for cosmetic brands and manufacturers placing products on the EU market under the EU Cosmetics Regulation. Our team supports CPNP notification, product information file management, regulatory communication, and ongoing compliance management.
Related Terms
Further Reading
