CEN/ISO 22716:2007

CEN/ISO 22716:2007 – Presumption of Conformity with Cosmetic GMP in Europe

in CEN/ISO 22716:2007, Frequently Asked Questions & Guides

Prepared between 2002 and 2006 by ISO Technical Committee 217, Working Group 6, the ISO standard 22716:2007 was published in November 2007.

While being an international standard, ISO 22716:2007 was adopted by the European Committee for Standardization (CEN) to become also a European Harmonized Standard (as published in the Official Journal of the European Union on April 21st 2011 – 2011/C 123/04) in reference to the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

ISO 22716:2007 provides guidelines for the production, control, storage and shipment of finished cosmetic products. However, it is not aimed at covering the quality aspects of the product, the personnel engaged in the manufacturing site or the protection of the environment. Read more


1. Introduction & definitions

in CEN/ISO 22716:2007

A base for GMP begins with a properly defined company structure supported by qualified and trained personnel. The company should record all procedures in writing and create control procedures concerning the company’s organizational chart, personnel tasks and responsibilities as well as training and flow of communications.

In practice, to maintain objectivity, the quality control unit is to be separated and run by different personnel than the manufacturing unit.

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2. Premises & equipment

in CEN/ISO 22716:2007

The premises of the company must be adequately designed and divided ensuring proper access and flow of materials, usage, and general maintenance. Furthermore, it should be ensured that no unwanted interactions or contaminations of the substances/products take place due to inadequate sanitization, cleaning, storage or other causes.

Commonly, access to the different areas within a manufacturing plant is to be restricted to authorized personnel only.

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3. Manufacturing process

in CEN/ISO 22716:2007

The company has to make sure that quality and safety criteria are set along the different stages of the manufacturing process, these being verified and approved by the quality control unit. Criteria on purchasing, identification, quality verification, storage and usage of raw materials must be established and followed, based on written and approved procedures. Procedures on the control of finished products and their storage should be set and documented as well.

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4. Deviations, complaints & recalls

in CEN/ISO 22716:2007

Criteria on what are considered to be deviations from initial requirements should be set and documented. The company should have procedures which allow complaints and recalls of products that did not reach the established criteria due to internal or external causes. A comprehensive investigation and follow up on these complaints and recalls should be documented until the satisfactory solution is reached.

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5. Improvement

in CEN/ISO 22716:2007

The 22716 GMP quality system, aims at improving the art activities and organizational aspects of the company. Therefore, organizations have to have a holistic view on their activities, being able to spot irregularities along the production chain. Internal audits should offer a perfect platform for analyzing the irregularities, create corrective and pr

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