Cybernetic Model Design for the Qualification of Pharmaceutical Facilities

Abstract

In this paper, an integrated cybernetic model for managing qualification activities when commissioning pharmaceutical facilities is created, focusing on defining critical factors that provide all the prerequisites for the start of the production process. An eight-year research and work on complex projects in the pharmaceutical industry is integrated into a scientific research endeavor focused on the qualification of pharmaceutical facilities. The newly designed cybernetic model for the qualification of pharmaceutical facilities is flexible and adaptive and has the most adequate elements so far recognized in practice and enables the qualification of smart facilities, in accordance with the concept of Pharma 4.0. Additionally, it meets the requirements of the regulatory authorities; therefore, it constantly initiates the search for better solutions and process improvements. Moreover, it is universal and, thus, applicable to all reconstructions in the pharmaceutical industry. The application of the designed model has been implemented in practice and has shown outstanding results, as it combines diversity and sustainability in project management. Also, the model focuses on indicating aspects that include risk management, scientific approach, experimental testing, numerical simulations, as well as the possibility of optimization and energy saving.