Abstract

To ensure the adequate microbiological quality and safety of cosmetic products, it is necessary to perform a number of microbiological tasks, which should be combined in a quality management system (microbiological quality management [MQM]) to reliably achieve the targets. If the tasks cannot be performed by the manufacturers’ own qualified personnel, they can be delegated to an external partner. The microbiological tasks may require laboratory facilities (e.g., examination for microbiological purity) or they may just be performed by persons with a professional expertise (e.g., microbiological safety assessment). The responsibilities for subcontracting activities lie with the principal as well as the contractor and are described in the text. Despite subcontracting certain tasks, the overall responsibility for the product remains with the principal, who accordingly has particular responsibility to ensure that all required microbiological tasks are performed effectively and to the required extent. Given the importance of an MQM System to reliably achieve the microbiological targets, the principal must establish and maintain such system that also ensures adequate communication and involves the external partner in essential processes. The external partner must guarantee that microbiological tasks are performed professionally. The results must be presented in a complete and independent way, and any risks detected should be reported.