Pharmaceutical Manufacturing Batch Record Review

23 April 2014, michigan, United States

Introduction

The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance and state of control. This program provides the foundation for an efficient and effective batch record review process and provides pharmaceutical companies with two strategies. First, the key to recognizing what your firm needs to demonstrate control of your manufacturing operations. And, secondly, how to put into place a proactive training regime and batch record review management system.