Research of FDA Risk-Based Drug Inspection Program and Its Enlightenment

摘要

Objective To carry out an on-site inspection to promote the optimal allocation of inspection resources through the introduction of risk management theory in the process of inspection because inspection can prevent drug quality deterioration and ensure drug safety and efficacy.Methods The application of Food and Drug Administration(FDA)risk management plan in pre-registration and daily supervision was analyzed to study the construction of inspection model for production site based on risk management procedures.Results and Conclusion In order to improve regulatory efficiency,China can establish a risk-based drug inspection system from FDA risk management plan.