Risk-based approach for validation of technological process

Abstract

Good manufacturing process is one of the most significant risk exclusion factors for patients due to lack of safety, efficacy or quality. Therefore, it is critical that the ability to continuously medicinal products of the required quality in accordance with the specifications and quality attributes has been demonstrated.
The aim of our research and this publication is to formulate a practical risk-oriented approach to process validation of the pharmaceutical production, taking into account modern requirements for both the process validation itself and the quality risk management system, in terms of defining and justifying the process control strategy for the subsequent routine manufacturing commercial batches of medicinal products, that would eliminate the risk for patients associated with lack of safety, efficacy or quality of medicinal products.
Materials and methods. The subject of the work is the analysis of modern requirements for validation of pharmaceutical production process and quality risk management system as processes of pharmaceutical quality system, and determination on this basis of practical model of implementation of risk-based approach to process validation (PV) – definition, justification and confirmation of effectiveness (efficiency) of control strategy of technological process of medicines production.
Results and discussion. According to the requirements of current guidelines, process validation should include the collection and evaluation of data that scientifically substantiate that the process can consistently ensure proper quality product throughout the product lifecycle, starting with its development, and validation activities should be based on quality risk management principles. The model of risk-oriented definition of process control strategy is considered, which is able to provide the possibility of practical application to any groups of pharmaceutical products and processes. It can be perceived as basic and, taking into account the specifics of each company, can be modified or detailed.
Conclusions. Based on the analysis of the place and role of process validation, we have proposed a comprehensive unified model for the implementation of a risk-based approach to process validation in terms of defining a process control strategy based on the principles of quality risk management recommended for the pharmaceutical industry.