EU Regulation (EC) no. 1223/2009 of the European Parliament and of the Council of 30 November 2009 provides that, to ensure their safety, cosmetic products placed on the market must be produced according to Good Manufacturing Practices (GMP). The ISO 22716 standard is the first international document laying down the principles for the application of Good Manufacturing by companies that produce cosmetics and is the harmonised standard pursuant to Article 8 of Reculationa (EC) no. 1223/2009. ISO 22716 which applies to production, control, storage and shipment of cosmetic products. It does not apply, however, to research and development activities or to the distribution of finished products.
ISO 22716 specifically governs the following areas:
- personnel (organisational structure, professional training, hygiene and health);
- management, cleaning and maintenance of premises and equipment;
- purchasing and control of raw materials and packaging materials;
- production, packaging and release of finished products;
- qualifications and monitoring of subcontractors;
- management of non-conforming products, re-evaluations and product recalls;
- management of deviations and change control;
- management of improvements following the implementation of corrective and preventive actions, based on deviations and complaints data analysis;
- necessary documentation (procedures / operating instructions / records) for proper management of the production, control and delivery processes of cosmetic products.