Pharmaceuticals for global markets are frequently sourced from a single manufacturing site. The standards used for manufacturing quality are, however, applied variably between the major pharmaceutical regulatory regions of the US, EU and Japan. Differences in chemistry, manufacturing and control data requirements between the major regions will also be discussed with respect to their potential impact on manufacturing operations.

• Illustrate the differences in manufacturing standards around the world and raise awareness of the cost implications of applying different standards
• Provoke discussions on current best manufacturing practices
• Identify potential solutions to overcome the current situation