Targeting R&D quality and compliance training for technology transfer into the GMP environment of production

Abstract

AbstractFor a long time, veterinary biological vaccine‐producing companies in the United States have been ruled by the quality and compliance requirements imposed by the United States Department of Agriculture (USDA). However, with the globalization of markets, companies now need to comply with quality and compliance guidelines of key foreign markets such as the European Union (EU), Japan and Canada. Since the quality of the final product is built in from inception, i.e. through all development phases, it is imperative that all research and development (R&D) personnel understand the basic global requirements for quality and compliance. This paper presents an innovative approach for designing a training program for R&D personnel in the basic quality and compliance requirements for global product development and technology transfer into production operating under strict good manufacturing practices (GMP) requirements. The training program integrated basic GMP requirements such as sourcing of raw materials, components, qualification of vendors, developing GMP compliant documentation for pilot batch production, setting specifications based on target countries and the proper use of change control. In addition the basics of good laboratory practice (GLP) requirements were incorporated into the training by including a section on the importance of the use of calibrated instrumentation/measuring devices and proper documented approved procedures. Copyright © 2001 John Wiley & Sons, Ltd.