Drug Stability Reporting

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The intent of this page is to have a repository of documents or artifacts associated with the Drug Stability Reporting (eStability)project.


Project

Drug Stability Reporting (eStability)

Project Number 275

Project Sponsor(s) RCRIM Work Group

Description

The project scope is to ballot a HL7 V3 Drug Stability Reporting (eStability) Release 2 Draft Standard for Trial Use (DSTU) message and the Implementation Guide (IG). The HL7 V3 Drug Stability Reporting (eStability) Release 1 is an approved HL7 and ANSI standard. Based on information gathered during the FDA pilot of Release 1 the message and IG were revised and Release 2 was proposed to be balloted as a DSTU. The scope includes: - Completion of DSTU testing and incorporation of changes or new requirements identified through DSTU testing. - Completion of IG.

eStability Project Scope Statement

Objectives / Deliverables

The goal of this project is to develop a method to provide stability data in a standard electronic format so that it may be viewed as it appears on paper or electronic paper by regulatory agencies and industry.

Additional information can be found at http://www.estability.org. We are using the wiki only at this site. The forum is an open forum which may contain objectionable material, use at your own risk.

Project Scope Details

Project Facilitator Norman Gregory

SD Approval Date Mar 28, 2006

TSC Approval Date Apr 21, 2008

PMO Approval Date Apr 23, 2008

Project Type Ballot - DSTU


Target:

Normative Ballot of Release 2 May 2010

Project Intent Revise Current Standard

Minutes

Project Intent Notes

It is possible that eStability could support the exchange of stability data for drug substances and drug products, including devices, internationally. Collaboration Efforts This project will be sponsored by the US FDA. Dependancies This project will strive to maintain consistency and harmonize with existing or new standards under development. These include:

  • Structured Product Labeling Standard
  • Pharmacy Medications DMIM

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