Improved Cosmetics through better GMP understanding

By Annemie Lambert, Director, AM Consultancy, Belgium

In 2013, the European Cosmetic Products Regulation (EC) N° 1223/2009 was implemented. One of the main purposes of this regulation is to improve the safety of cosmetic products made available to the public of the EU market. Provided one adheres to the requirements established in this specific Regulation, safe products would be placed on the market.

If you manufacture cosmetics, you can reduce the risk of adulteration or misbranding by following the Good Manufacturing Principles (GMP). Even more, the obligation to produce cosmetic products according to GMP is documented in Art. 8 of the European Cosmetic Products Regulation (EC) N° 1223/2009.

In September 2007, the regulators from the EU, USA, Canada and Japan agreed to take ISO standards for cosmetic GMPs into consideration when developing or updating guidelines addressing GMPs. As a result of this, ISO 22716 (Cosmetics- Good Manufacturing Practices – Guidelines on Good Manufacturing Practices, ISO 22716/2007, Geneva, Switzerland), became a worldwide guidance for GMP implementation. The objective of these guidelines is to define the activities to be performed in a manufacturing environment to obtain a product that meets defined product characteristics.

The guidelines give practical advice on managerial, technical and administrative factors; however, topics about personnel-/quality assurance such as change control, deviation management, documentation, complaints and recalls are not neglected. QC, microbiology and release of product are covered as well as manufacturing, packaging, storage and shipping.

If we adhere to GMPs and their quality standards during production, we improve the quality of the cosmetic product, are able to produce products meeting the requirements established in the Product Information File (PIF) and thus put product on the market that remains safe under normal shipping and usage conditions.