ISO 22716

ISO 22716 – Cosmetics. Good Manufacturing Practices (GMP)

ISO 22716:2007 (SR EN ISO 22716:2008 – Romanian standard) specifies guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover aspects of product quality, but do not apply to research and development activities or the distribution of finished products, nor do they cover aspects related to the safety of personnel employed in the factory or aspects related to environmental protection.

ISO 22716 specifies organizational and practical guidelines regarding good manufacturing practices for cosmetic products and it is applied within the organizations in this sector, taking into account the specific needs. The guidelines aim at the management of human, technical and administrative factors that affect the quality of manufactured cosmetic products and follow the production flow from the receipt of raw materials to the shipment to end users.

In the current conditions of the market economy, quality must be considered the strategic key to product competitiveness, including for organizations in the cosmetics sector. Cosmetic products must simultaneously meet two basic conditions: to be useful and profitable. Because it plays an essential role in the performance of the modern organization, quality must represent the main concern within the management due to the economic and social implications that are of great depth.

The implementation and certification of good manufacturing practices (GMP) in the field of cosmetics demonstrates the ability and commitment of the organization to maintain quality in all stages of production and to obtain products in accordance with the defined characteristics.
The GMP certification scheme evaluates the conformity of the quality management system and the observance of good manufacturing practices along the entire manufacturing flow, from the acquisition of raw materials to the transport to the end user

The third-party audit for GMP evaluates the compliance and effectiveness of the system implemented by the organization from the point of view of the requirements of the ISO 22716 standard regarding:

the structure of the organization (organizational chart, responsibilities and attributions);

competence, training, personal hygiene and health;

appropriate locations, spaces and equipment, corresponding to the production flow, their cleaning and disinfection;

raw materials and packaging; their reception, storage and use;

the process of manufacturing, packaging, releasing, storing and shipping cosmetic products;

quality control (defined methods for sampling and testing, acceptance criteria, etc.);

control of non-compliant outputs and treatment of complaints, recalls (complaints, returns, withdrawals);

waste management;

control of outsourced processes;

internal audit;

control of documents and records.