Pharmaceutical, cosmetic and chemical industries / Standardisation and quality of services and organisations / Cosmetics – Good Manufacturing Practices (GMP) UNE-EN ISO 22716

Cosmetics – Good Manufacturing Practices (GMP) UNE-EN ISO 22716

Good manufacturing practices (GMP) for cosmetic products are included in the UNE-EN ISO 22716: 2008. This standard is mandatory for all cosmetic manufacturers, according to Regulation (EC) No. 1223/2009, on cosmetic products.

Regulation (EC) 1223/2009 establishes that cosmetic products must be safe. Composition and labelling guidelines and standards must be installed and adhered to it. Also, manufacturers (or their representatives) must designate responsibilities and obligations to ensure traceability in the supply chain.

Cosmetic products must have a technical file available to the competent authority, which, among other information, will include a report about their safety.

The fabricant has to ensure the safety of cosmetic products establishing guidelines or principles of the good manufacturing practice. Good manufacturing systems are installed following ISO 22716. Regulation (EC) No. 1223/2009, on cosmetic products, provides the obligation to report severe unwanted effects to national authorities.

What is a cosmetic product?

A cosmetic product is any substance or mixture intended to be put in contact with the superficial parts of the human body (epidermis, hair and capillary system, nails, lips and external genital organs) or with the teeth and oral mucous membranes, for the exclusive or mainly purpose to clean them, perfume them, modify their appearance, protect them, keep them in good condition or correct body odours.

E.G. Hormonal or endocrine disruptors, hair dyes, sun protection products, hygiene products and body or facial protection, hairdressing products…

Good Manufacturing Practices (GMP) for cosmetic products

Good manufacturing practices (GMP) for cosmetic products must be based on UNE-EN ISO 22716: 2008, which establishes guidelines for the production, control, storage and dispatch of cosmetic products.

ISO 22716 establishes guidelines regarding the quality of cosmetic products, but it is not directed to aspects related to occupational health and safety or sustainability. Nor does it cover aspects relating to product research and development or their distribution.

The guidelines established in UNE-EN ISO 22716 standardise the following aspects:

1.-Staff,

2.- Premises (facilities),

3.- Production equipment,

4.- Raw materials and packaging material,

5.- Production,

6.- Finished products,

7.- Quality control laboratory,

8.- Treatment of products out of specifications,

9.- Waste,

10.- Subcontracting,

11.- Deviations,

12.- Claims and withdrawal from the market,

13.- Change control,

14.- Internal audits,

15.- Documentation.

We provide solutions

OAK has been developing consulting projects in the field of standardisation for 20 years. The experience developed allows us to have a system that we invest in clients. We provide solutions, and we do complex projects easy.

reglamento ce n 1223 2009 productos cosmeticos

As a guideline, our projects take into account the most relevant sectoral standards as well as the main improvement guidelines, such as the EFQM Excellence Model, Lean management or the UNE-EN ISO 9004.

The UNE-EN ISO 22716 projects developed by our company provide benefits and advantages to companies and marketing organisations:

Improves management, organisation, planning and control guidelines,
Establishment in the organisation of the concept of continuous improvement,
Improves the image and confidence of the products manufactured before the interest groups (clients, suppliers, administrations…),
Access to new markets,
Establishment of robust quality and safety guidelines.

In addition to the establishment of the BPF ISO 22716 system, we help our clients with our intervention and support during certification (Aenor, Lloyds Register, DQS, EQA…) and even in the management of the file before the Spanish Agency of medicines and health products (AEMPS).

Our scope of work is the entire peninsula, especially Catalonia, Aragon, Valencia, Euskadi, Castilla and Leon, Balearic Islands, Madrid, Extremadura and Andalusia.

This solution is aimed at

Manufacturers of any cosmetic product (according to Regulation (EC) No. 1223/2009),
Service providers related to cosmetics,
Manufacturers of raw materials and packaging material.

What our customers get

UNE-EN ISO 22716 certification (Aenor, Bureau Veritas, DQS, Lloyds Register, OCA global…).
Compliance and establishment of guidelines of the Regulation (EC) 1223/2009.

Satisfied customers

Jose Collado S. A.

Jose Collado S. A. is a company specialised in the formulation, manufacture and sale of hygiene products.

4040 NATURAL COSMETIC S.L.

4040 NATURAL COSMETIC S.L. is dedicated to the manufacture, storage and marketing of toilet soaps and other perfumery and cosmetic products.

Synergies

Good Manufacturing Practices to cosmetic products projects can be easily combined with any ISO 9001, ISO 14001 or ISO 45001 management system as well as lean management organisation guidelines or the EFQM Excellence Model.

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