SCIENCE AND RISK BASED APPROACH TO THE PROCESS VALIDATION – LINK FROM QUALITY BY DESIGN TO PROCESS VALIDATION.

摘要

The approach to the process validation of pharmaceutical manufacturing processes has been changed and the minimal approach (traditional) is no longer recommended 1-6. As the regulatory requirements are being changed, considering the patient safety and drug efficacy, an enhanced and science based approach is recommended for the process validation of medicinal product manufacturing processes. The major regulatory bodies like USFDA and EU has revised their approaches towards process validation and recommending industry to proceed with enhanced approach towards process validation. To reach the regulatory requirements regarding the process validation, tools like Quality risk management (ICH Q9), Pharmaceutical quality systems (ICH Q10) shall be useful. In-addition Quality by design is a new approach, which is a combination of several Quality system elements like Pharmaceutical development, Quality risk management, Pharmaceutical quality system which will leads to a life cycle approach to the process validation 7. This article will enable the readers to understand the science and risk approaches to the process validation, and usage of Quality by design concepts while developing a design space for the manufacturing process as recommended by ICH, FDA and EU