Good Manufacturing Practices (GMP)
Cosmetic GMP: What Good Manufacturing Practices Are According to ISO 22716
Cosmetic GMP, an acronym for Good Manufacturing Practices, refers to the Good Manufacturing Practices applicable to the production of cosmetic products.
In the cosmetic sector, product quality does not depend only on the formulation, but also on the way the product is manufactured, controlled, stored and shipped. For this reason, Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured in compliance with Good Manufacturing Practices.
The purpose of GMP is to ensure that each cosmetic product is manufactured according to controlled, documented and repeatable procedures, reducing the risk of errors, contamination, non-conformities and quality issues.
The Regulatory Reference: Article 8 of Regulation (EC) No 1223/2009
Article 8 of Regulation (EC) No 1223/2009 states that Good Manufacturing Practices must be respected in the manufacture of cosmetic products.
The same article provides that, where manufacturing is carried out in accordance with the relevant harmonised standards published in the Official Journal of the European Union, compliance with GMP is presumed. In the cosmetic sector, the main technical reference is UNI EN ISO 22716.
It is important to distinguish between two aspects:
compliance with GMP is a requirement under European cosmetic legislation;
ISO 22716 is the technical standard of reference for organising and demonstrating the application of Good Manufacturing Practices.
What Is UNI EN ISO 22716?
UNI EN ISO 22716 provides guidelines for the production, control, storage and shipment of cosmetic products. The standard focuses on the quality aspects of the product and defines an organised approach to the management of cosmetic manufacturing processes.
Its application allows companies to structure a working system based on procedures, defined responsibilities, documented controls and management of any non-conformities.
In other words, ISO 22716 helps a company demonstrate that a cosmetic product has been manufactured under appropriate conditions of quality, hygiene and control.
Who Do Cosmetic GMP Apply To?
GMP are relevant to all operators involved in the manufacture and management of cosmetic products.
In particular, they are important for:
- cosmetic manufacturing companies;
- contract manufacturers and production sites;
- companies that package or repackage cosmetic products;
- brand owners who outsource manufacturing to third parties;
- importers and Responsible Persons who must verify the adequacy of documentation and manufacturing processes;
- quality control laboratories and operators involved in finished product management.
Even when production is outsourced to a contract manufacturer, proper GMP management remains a key element of the overall compliance of the cosmetic product.
What Do GMP Cover According to ISO 22716?
Good Manufacturing Practices do not only concern the manufacturing phase in the strict sense. On the contrary, they involve all aspects that may affect the quality of the cosmetic product.
ISO 22716 covers, among others, the following areas:
- personnel;
- premises;
- equipment;
- raw materials;
- packaging materials;
- production;
- finished products;
- quality control laboratory;
- treatment of products that are out of specification;
- waste management;
- subcontracting;
- deviations;
- complaints and recalls;
- change control;
- internal audit;
- documentation.
These elements help create a more organised, traceable and controlled manufacturing system.
Why Documentation Is Essential
One of the key aspects of cosmetic GMP is documentation.
Operating procedures, manufacturing records, quality controls, raw material qualifications, deviation management and batch traceability are essential tools to demonstrate that the product has been manufactured correctly.
Incomplete or outdated documentation may represent a critical issue, especially in the event of inspections by competent authorities, complaints, recalls or product safety checks.
For this reason, documentation management must be clear, up to date and consistent with the activities actually carried out by the company.
GMP and PIF: What Is the Connection?
Compliance with GMP is also linked to the regulatory documentation of the cosmetic product.
In the PIF – Product Information File, information on the manufacturing method and a statement of compliance with Good Manufacturing Practices must be available.
This means that GMP compliance is not an isolated requirement, but part of the broader compliance system required for placing a cosmetic product on the market.
Is ISO 22716 Certification Mandatory?
European cosmetic legislation requires compliance with GMP, but does not necessarily require ISO 22716 certification.
However, certification issued by a competent body may be a useful tool to demonstrate the application of Good Manufacturing Practices in a more structured way.
In any case, even without certification, the company must be able to demonstrate that its cosmetic products are manufactured in compliance with GMP.
Why GMP Are Important for Cosmetic Companies
The application of GMP allows companies to improve process control and reduce the risk of problems during manufacturing and commercialisation of the product.
The main benefits include:
- greater control over product quality;
- reduced risk of contamination or manufacturing errors;
- improved batch traceability;
- more effective management of complaints, deviations and recalls;
- greater reliability in relationships with customers, suppliers and authorities;
- support for the regulatory compliance of the cosmetic product.
GMP are therefore an essential tool not only for complying with legislation, but also for improving internal organisation and overall product quality.
Conclusions
Cosmetic GMP are a fundamental requirement to ensure that cosmetic products are manufactured, controlled, stored and shipped according to appropriate quality and safety criteria.
UNI EN ISO 22716 is the main technical reference for applying Good Manufacturing Practices in the cosmetic sector and represents an important tool for demonstrating compliance with Regulation (EC) No 1223/2009.
For cosmetic companies, adopting an effective GMP system means working with clear procedures, adequate documentation, structured controls and safer, more traceable processes.
Proper application of GMP helps prevent non-conformities, improve manufacturing management and ensure a higher level of protection for the final consumer.