Requirements for Subcontracting Microbiological Tasks by Cosmetics Manufacturers

To ensure the adequate microbiological quality and safety of cosmetic products, it is necessary to perform a number of microbiologicalTo ensure the adequate microbiological quality and safety of cosmetic products, it is necessary to perform a number of microbiologicaltasks, 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 bedelegated to an external partner. The microbiological tasks may require laboratory facilities (e.g., examination for microbiologicalpurity) or they may just be performed by persons with a professional expertise (e.g., microbiological safety assessment). Theresponsibilities for subcontracting activities lie with the principal as well as the contractor and are described in the text. Despitesubcontracting certain tasks, the overall responsibility for the product remains with the principal, who accordingly has particularresponsibility to ensure that all required microbiological tasks are performed effectively and to the required extent. Given theimportance of an MQM System to reliably achieve the microbiological targets, the principal must establish and maintain suchsystem that also ensures adequate communication and involves the external partner in essential processes. The external partnermust guarantee that microbiological tasks are performed professionally. The results must be presented in a complete and independentway, and any risks detected should be reported.