Dr. Richard Soltero will be a featured speaker at The Clinical Supply Forum on February 9th. His topic is “GMP Manufacturing for Worldwide Clinical Trials”

This presentation will describe the complex process of manufacturing clinical trial materials using examples from the InstantGMP manufacturing execution system. InstantGMP is an electronic batch record system for small pharmaceutical operations and is ideal for manufacturing CTM or tracking inventory worldwide.

With more and more clinical trials being conducted globally, it is important that manufacturers are aware of the different GMP requirements in each of the countries where their product will be distributed for clinical trials. The discussion will explore the internal processes in manufacturing facilities and the requirements they may need to meet for making supplies for different countries around the world.

“While many countries profess to have GMP manufacturing laws” stated Dr. Soltero, “their actual compliance may not represent their legal intentions.”

One of the advantages of internet based manufacturing systems is on-line inventory control. With clinical materials going to multiple countries and sites, an on-line inventory system allows that clinical groups to continuously monitor where and when clinical supplies have been distributed.

“What is GMP” for various global regions is described in a series of articles available at the InstantGMP Resource Center and points out the differences in regulations that clinical monitors should know about.

More information about the Clinical Trials Forum can be found at www.ClinicalSupplySolutions.com .