Another novelty introduced by the regulation EC 1223/2009 on cosmetic products are GMP (Good Manufacturing Practices). As for drugs and medical devices, also for cosmetic products a set of rules to ensure product quality and consumer health must be respected.
Article 8 Reg (EC) 1223/2009
- The manufacture of cosmetic products shall comply with good manufacturing practice.
- Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union
ISO 22716
These guidelines are intended to provide guidance regarding Good Manufacturing Practices for cosmetic products. These guidelines have been prepared for consideration by the cosmetic industry and take into account the specific needs of this sector. These guidelines offer organizational and practical advice on the management of the human, technical and administrative factors affecting product quality. These guidelines have been written to allow them to be used following the flow of products from receipt to shipment. Additionally, in order to clarify the way this document reaches its objectives, a ‘principle’ is added to each major section. Good Manufacturing Practices constitute the practical development of the quality assurance concept through the description of the plant activities that are based on sound scientific judgement and risk assessments. The objective of these GMP guidelines is to define the activities that enable you to obtain a product that meets defined characteristics.
Briefly, these Guidelines regulates the following procedures regarding the manufacture of the cosmetic product:
- PERSONNEL
- PREMISES
- EQUIPMENT
- RAW MATERIALS AND PACKAGING MATERIALS
- PRODUCTION
- FINISHED PRODUCT
- QUALITY CONTROL LABORATORY
- TREATMENT OF PRODUCT THAT IS OUT OF SPECIFICATION
- WASTES
- SUBCONTRACTING
- DEVIATIONS
- COMPLAINTS AND RECALL
- CHANGE CONTROL
- INTERNAL AUDIT
- DOCUMENTATION
