« View all Life Sciences posts

IDMP and the Requirement for Substance Information

Written by Steve Scribner on 03/10/16

IDMP is an important concept and pending requirement for all Pharma. There have been many white papers, webinars and conference talks addressing it. It will surely require a responsive and collaborative organization to discover and collect the required information that will be demanded, even for Iteration 1. I hope that most of you have been busy analyzing the gap between your current capabilities and the future specifications.

There is one topic that I feel is perhaps being ignored, or treated too lightly. That is the requirement to identify all product components (substances). Substance data is required as part of Iteration 1. A database has been built and updated called ginas (Global Ingredient Archival System) and is available today as version 1.1 (beta). It is currently installed at the FDA and EMA has decided to use it as well. The latest status I have are that about 85k substances have been loaded. It may be used locally with a seed dataset of about 8k substances. 

Download it and use it within your own organizations. It is database agnostic and can be connected to various databases management systems.

However, not all substances have been loaded to date, probably including some that you use today in your products. You may find it very valuable to create new records for substances that you or your CMOs use in the delivery of your drug compounds and submit them to the Central GSRS database. For example, no data has been loaded currently on flavors or colorants.  

Extensions for vaccines, allergenics, structurally diverse substances and advanced therapies are coming in 2017.

More about ginas



Topics:
IDMP






Steve Scribner

Written by Steve Scribner

Steve is a Consultant with 45 years of experience in computer solutions implementation in business. For the past 22 years, he has focused on electronic document/content management systems in the Pharmaceutical / Life Sciences industries. Steve has an extensive experience with managing multinational projects and looks for circumstances where his understanding of diverse cultures can help projects be successful. He has lived and worked in US, Western Europe and Asia.

Related posts

Comments