ISO 22716: GLOBAL SOLUTIONS FOR ENSURING THE SAFETY OF COSMETIC PRODUCTS

WHY ISO 22716?

ISO 22716 is a comprehensive cosmetic safety management systems standard, because it:

  • Integrates the typical requirements for product and process quality Good Manufacturing Practices requirements with other quality guidance, for example as laid down in the pre-requisites for ISO 9001
  • Allows for easy implementation in organizations of all sizes and levels of complexity
  • Forms an internationally accepted basis for quality and safety compliance in the cosmetic products supply chain
  • Fosters legal compliance as adopted by regulators around the world
  • Controls and reduces cosmetic products hazards and promotes continuous improvement throughout the supply chain

ISO 22716 PROVIDES PRODUCTION, CONTROL, STORAGE AND SHIPMENT QUALITY GUIDELINES

ISO 22716 combines the benefits of a business management tool linking cosmetics quality and business processes with the ability to meet growing global legal and customer requirements for safe cosmetic products. Specifically, this globally recognized Standard addresses and responds to international laws for cosmetic Good Manufacturing Practice. It has gained worldwide support through the International Cooperation on Cosmetic Regulation (ICCR) regions of the European Union, US, Canada and Japan and as such has led to adaptations of their own home-grown standards and guidance as it ties in so effectively with their legislation. ISO 22716 demands that organizations define their processes and demonstrate consistent control over identified hazards, updating and improving systems to adapt to changes in processes. It provides real value to an organization irrespective of its size and complexity. It levels the playing field for customers and suppliers throughout the supply chain and around the world.

THE COMPONENTS OF ISO 22716

ISO 22716 deals with all aspects of the supply chain of cosmetic products, from the early delivery of raw materials and components until the shipment of the final product to the consumer. The guidelines support those organizations that wish to follow the practical advices to manage their human, technical, and administrative sections that are affecting product quality. Good Manufacturing Practices follow the principles of sound scientific judgement and risk assessment to produce products that meet defined characteristics.

Broad Scope for ISO 22716

ISO 22716 gives guidelines for the production, control, storage and shipment of cosmetic products. These guidelines cover the quality and safety aspects of the product. In this way manufacturers of cosmetic final products are affected, as are the suppliers of cosmetic ingredients. In addition, the standard is relevant for retailers, brand holders and wholesalers of cosmetic products striving to enhance the overall quality performance of their third party suppliers, but excludes distributors. Furthermore, it specifies general requirements for quality management systems by incorporating a risk assessment based approach to define critical and non-critical elements ensuring high quality supply chain operations.

Consistent Terminology

In an effort to reach and maintain consistency and encourage the use of common terminology, the ISO 22716 terms and definitions section contains a set 36 definitions that are specific to their application. The rationale behind the definition section is to provide clarity of terminology and promote the use of a common language.

CORE ELEMENTS

ISO 22716 can be thought of as being composed of five core elements:

  • The cosmetics quality management system and organization
  • Premises and equipment
  • Product realization and materials management
  • Deviations, complaints and recalls
  • Continuous improvement

The Cosmetics Quality Management System and Organization

In a cosmetics GMP quality management organization, the emphasis is on establishing and maintaining a qualified personnel base that is well trained and capable of consistently producing safe products. A sound knowledge base of the personnel in a cosmetics manufacturing organization is of the utmost importance and this area is receiving serious attention in quality guidance. Another crucial element is a clear description of tasks and lines of responsibilities of all personnel in the organization.

Furthermore, setting up effective internal and external communication channels has to be the top priority of management to ensure the participation and commitment of personnel at all levels of the organization. All these and other aspects of the quality organization need to be established in formal writing – a controlled documentation system is therefore an intrinsic part of organizations working under ISO 22716.