US-EU Comparative Analysis and Interpretations

摘要

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and actiwe pharmaceutical Ingredients, These different requirements mean that companies with international supply chains face the task of preparing separate reviews or combining the requirements of both regions to comply with EU and US good manufacturing practices.This article compares the requirements for the annual review between the US and EU?analyzes some of the major differences, and provides Interpretations and recommendations for several rewiew requirements.