Safeguarding Microbiological Quality and Safety of Cosmetic Products through a System Approach

U. Eigener

The EC-cosmetics regulation (1223/2009) defines requirements for the adequate quality and safety of cosmetic products.
These requirements include microbiological aspects. Accordingly, microbiological objectives have to be fulfilled in various processes.
These objectives can only reliably be reached by means of quality management systems (QMS), which cover all relevant
processes. Such a system is presented by the GMP-guidelines (ISO 22716) which is part of the cosmetics regulation. Since microbiological
objectives are also located in processes which are not in the scope of the GMP-guidelines (development, up-scaling,
safety assessment) the system approach must be enlarged to include all microbiological activities: the MQM (microbiological
quality management) is used as QMS. In this way, general system targets, which are covered for instance in the GMP-guidelines,
can also be also applied for other processes, and thereby, microbiological quality and safety targets can be controlled in a holistic
way. The system application (GMP and MQM) also allows for the systematic microbiological risk management which provides
the basis for the safety statement. The MQM-system is used in the microbiological area as weight-of-evidence approach for
the data used for the safety statement. The text describes how system elements of GMP and then also of the MQM-system are
employed in practice as well as their importance for the microbiological quality and safety of cosmetic products.


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