Validation Strategy Based On Application Of Quality Risk Management In Pharmaceutical Technology Transfer

Risk management is a systematic process for the assessment and control of the risk in a forward-looking or retrospective manner,and has been used in many fields of the pharmaceutical industry in recent years.Technology transfer is an important component of the drug life cycle.Now,some multinational corporations have established a set of suitable validation strategy and procedures for technology transfer,based on application of quality risk management.However,many other pharmaceutical companies have not yet formulated a comprehensive system which guides the practice of transfer technology in pharmaceutical development and manufacturing.The technology transfer project is similar to other project activities that require a clear organization to manage and execute the business.It is an arduous task to figure out the feasible plan for the project and deploy various resources suitably so as to ensure that projects teams conduct and complete each work effectively.The product will meet quality standards after the successful transferring the technology from development lab to manufacturing site,and the regulation registration is completed within the expected schedule.This paper,starting with the theory of pharmaceutical technology transfer and following the characteristics of drug life cycle,describes the stage divisions and working contents for each stage.Moreover,the paper discusses the plan and implementation strategy of the project's verification and validation.Research method of combining theoretical analysis with practical case study of domestic innovative drugs was discussed to elaborate on the importance of risk management in the technology transfer and the feasibility of its implementation from different aspects.This paper takes the product technology transfer project of a biopharmaceutical company as the research subject and describes the progress of the project according to its current situation.In addition,the paper focuses on the quality risk management and verification strategy;analyzes the problems encountered in the process;and gives suggestions for its improvement.It aims to provide available strategies and references to pharmaceutical companies in which technology transfer systems have not yet been fully established.