Section 1e: Version 3 (V3)
Section 2: Clinical and Administrative Domains
Section 3: Implementation Guides

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3

DESCRIPTION

This implementation guide for Drug Stability Reporting (eStability) describes the basic requirements needed for using the standard, and the requirements needed for submitting information to the Food and Drug Administration (FDA) agencies using the standard. It is meant to be used for all regulated products (e.g., test kits, drugs, reagents, medicated feeds, etc.), excluding foods.

ALTERNATIVE NAMES

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3 may also go by the following names or acronyms:

"V3 IG: Drug Stability Reporting R2, R3", V3, DSR

TARGETS

  • Regulated drug industry
  • Regulator agencies
  • Contract test laboratories
  • Pharmaceutical Companies
  • Clinical Research Organizations
  • Veterinary Drug Products Companies

BENEFITS

  • Defines standards for electronic submission of stability reporting information to FDA

IMPLEMENTATIONS/CASE STUDIES

  • U.S. FDA and industry users

DEVELOPMENT BACKGROUND

The HL7 Stability Standard is for one way communication between contractor to company, company to company, company to regulatory agency. It can be used to report results of stability studies carried out on a drug product to a regulatory authority. Additionally, the standard can be used to update the results of a previously submitted study or withdraw a previously submitted study. It provides a digital representation of stability testing results as compared to current practice of submitting report documents.

 

 

RELATED DOCUMENTS

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 3

(Download) (2.54 MB)

HL7 Version 3 Implementation Guide: Drug Stability Reporting (eStability) R2, Release 2 (View Brief)

(Download) (795 KB)

TOPIC

  • Regulated Studies

BALLOT TYPE

  • Informative

STATUS DATE

2011-11-15

RESPONSIBLE WORK GROUP

Biomedical Research and Regulation

FAMILY

  • V3

CURRENT STATE

  • Stable

REALM

  • Universal