Foreword

ISO (the International Organization for Standardization) is a global federation of national standards bodies (ISO member bodies). The preparation of International Standards is typically carried out through ISO technical committees. Each member body with an interest in a specific subject, for which a technical committee exists, has the right to participate in that committee. International organizations, both governmental and non-governmental, also collaborate with ISO in this process. ISO works closely with the International Electrotechnical Commission (IEC) on matters of electrotechnical standardization.

International Standards are drafted in line with the rules set out in the ISO/IEC Directives, Part 2. The primary function of technical committees is to develop International Standards. Drafts of these standards are circulated to member bodies for voting. To be published as an International Standard, the draft must receive approval from at least 75% of the voting member bodies.

It is important to note that some elements of this document may be subject to patent rights. ISO does not assume responsibility for identifying any or all such patent rights.

ISO 22716 was developed by Technical Committee ISO/TC 217, Cosmetics.

This corrected version includes syntactical changes in subclauses 3.2.1.1 and 11.2 for clarity.

Introduction

These guidelines are designed to provide recommendations for Good Manufacturing Practices (GMP) for cosmetic products. They have been developed with the cosmetic industry’s specific needs in mind and offer practical and organizational advice on managing the human, technical, and administrative factors that impact product quality.

The guidelines are structured to align with the flow of products from receipt to shipment. Additionally, a ‘principle’ is included in each major section to clarify how the objectives of the document are to be met.

Good Manufacturing Practices represent the practical application of the quality assurance concept, focusing on plant activities based on sound scientific judgment and risk assessments. The goal of these GMP guidelines is to outline the activities that ensure the production of a product that meets predefined quality characteristics.

Documentation is a critical component of Good Manufacturing Practices.

Scope

This International Standard provides guidelines for the production, control, storage, and shipment of cosmetic products.

These guidelines address the quality aspects of the product but do not cover the safety aspects for personnel in the plant or environmental protection issues. Safety and environmental responsibilities fall to the company and may be regulated by local laws and regulations.

The guidelines do not apply to research and development activities or the distribution of finished products.