While many countries profess to have GMP manufacturing laws” stated Dr. Soltero, “their actual compliance may not represent their legal intentions.
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Cary, NC (PRWEB) January 23, 2012
InstantGMP is pleased to announce that 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 Pharmaceutical Production] for small pharmaceutical operations and is ideal for manufacturing CTM and for tracking inventory worldwide.
With more and more clinical trials being conducted globally, it is important that clinical trial coordinators 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 need to meet for making supplies in different countries around the world.
What is GMP for various global regions is described in a series of articles available at the InstantGMP Resource Center.
More information about the Clinical Trials Forum can be found at the ClinicalSupplySolutions.com website.
Instant GMP™ is a web-based Part 11 compliant Electronic Batch Record System that streamlines the entire process of pharmaceutical manufacturing. It simplifies the documentation and approval procedures to reduce production times. It has hard coded Quality-Assurance procedures built in to prevent errors and to maximize quality and to assure GMP-Compliance. It can be viewed remotely from any location and has individualized security settings on every screen. The net result is better efficiency and higher quality than can be achieved with paper based systems.