Good Manufacturing Practices (GMP)
One of the innovations introduced by Regulation (EC) No 1223/2009 on cosmetic products is the obligation to follow Good Manufacturing Practices (GMP). As with medicines and medical devices, cosmetic manufacturing must comply with a series of rules designed to guarantee product quality and consumer safety.
Article 8 of Regulation (EC) No 1223/2009
- The manufacture of cosmetic products shall comply with good manufacturing practice.
- Where manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union, compliance with good manufacturing practice shall be presumed.
Article 8 therefore directs cosmetic manufacturers to use UNI EN ISO 22716 as the harmonised standard for manufacturing cosmetics in compliance with GMP requirements.
ISO 22716 
UNI EN ISO 22716 sets out guidelines for the production, control, storage and shipment of cosmetic products with the aim of guaranteeing consumers high safety and hygiene standards. It is the harmonised reference text used to demonstrate compliance with the Good Manufacturing Practices required by Regulation 1223/2009. It applies to all cosmetic products and takes into account all the factors and activities relevant to obtaining a compliant cosmetic product.
In short, the standard covers the following processes involved in the manufacture of cosmetic products:
- PERSONNEL
- PREMISES
- EQUIPMENT
- RAW MATERIALS AND PACKAGING MATERIALS
- PRODUCTION
- FINISHED PRODUCTS
- QUALITY CONTROL LABORATORY
- TREATMENT OF OUT-OF-SPECIFICATION PRODUCTS
- WASTE
- SUBCONTRACTING
- DEVIATIONS
- COMPLAINTS AND RECALLS
- CHANGE CONTROL
- INTERNAL AUDIT
- DOCUMENTATION