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Product Brief - HL7 V3 Regulated Studies: Drug Stability Reporting (eStability)

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Product Name

Drug Stability Reporting (eStability)

Topics

  • Drug Stability Reporting (eStability)

Standard Category

  • Health Information Exchange Standards

Integration Paradigm

  • Messages

Type

Normative, ANSI Standard

Releases

ANSI/HL7 V3 DSR, R1-2005

Summary

The Drug Stability Reporting (eStability) HL7 standard was created to transfer stability data electronically. The eStability standard can support the exchange of stability data for drug substances and drug products, including devices, internationally. A necessary step for submitting eStability to the FDA was to have a standard format for the data. Therefore the FDA, sponsors, and vendors are working together within HL7 to create a standard to meet the needs.

The eStability standard was created by HL7’s Regulated Clinical Research Information Management (RCRIM) Work Group in response to the FDA’s need.


Description

At this time, sponsors submit their Drug Stability Reports in their applications as text in their own format, which can change frequently, and not consistently containing the same information. The eStability Standard will standardize the format and the type of information in Drug Stability Reports for drug substances and drug products, and drug devices. HL7’s Regulated Clinical Research Information Management (RCRIM), in response to the FDA’s need, created the Drug Stability Reporting (eStability) standard.

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 Implementation Guide (IG) were revised and Release 2 was balloted as a Draft Standard for Trial Use (DSTU). The eStability Release 2 DSTU period ends February 2010. The intent is to complete the DSTU testing and incorporated any changes and new requirements to the message and IG identified through DSTU testing and go to normative ballot for eStability Release 2 and informative ballot for the IG May 2010.

THE PURPOSE OF eSTABILITY The purpose of eStability 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.


Business Case (Intended Use, Customers)

  • FDA,
  • Pharmaceutical Industry,
  • Contract testing labs

Benefits

The standard provides a common format, including the type of information, for Drug Stability Reporting and allows electronic storage of the information. This will allow quicker and more consistent analysis of Stability Drug Reports.

Implementations/ Case Studies (Actual Users)

Resources

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. http://www.fda.gov/ForIndustry/DataStandards/StabilityDataStandard/default.htm

Work Groups

Regulated Clinical Research Information Management (RCRIM) Work Group

Education

Relationship to/ Dependencies on, other standards

  • Structured Product Labeling Standard
  • Common Product Model
  • Pharmacy Medications DMIM

Links to current projects in development