Reflections on GMP Compliance Inspections under the New Situation
After the revision and implementation of the Drug Administration Law and the Drug Production Supervision and Management Rules,the concept of good manufacturing practice(GMP)compliance inspection was proposed.Taking Shandong Province as an example,GMP inspections applied by enterprises include renovation and expansion of production lines,site changes,commissioned production,etc.In addition,marketing authorization holders or drug manufacturing enterprises also undergo licensing inspections,registration checks,and post-market inspections.Frequent inspections pose new challenges to enterprises and inspection resources.This article focuses on laws,regulations and policies that form the basis of GMP inspections,as well as the dosage forms or types,inspection situations,and inspection demands displayed in a questionnaire survey conducted for Shandong enterprises.Combining actual inspections with principles of risk-based management,this paper explores opinions and suggestions for conducting GMP compliance inspections.
good manufacturing practicecompliance inspectioninspection situationrisk management
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