HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-04-19

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

April 19, 2010

Attendees:

Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Diane Miller (Alpharma), and Chuck Warner (Beckloff Associates)

  • Input Tool - “Product/Substance” tab under Status has "Approved", "Proposed", and “Not Established”. We had talked about changing “Not Established” to “Non Indicating”, but after further discussion we will just have "Approved", "Proposed". The status is for the approved or proposed expiry data at labeled storage condition for the Product/Substance the report is for, and not necessarily what the report is about (e.g., a photostability report is for a specific Product/Substance that has an approved or proposed expiry data, but this specific report is not confirming that). The IG will need to explain this.
  • When we talk about storage; if we mean the condition (temperature and humidity) and the orientation we need need to make sure we say that.
  • The existing examples for the stylesheet are to show what can be done, not necessarily they way it should be done.
  • Catherine try X forms again and could not get it to work. The XForm and Input Tool (.NET) environments are dependent on what version you are using, and what version of IE you have. Windows 7 does not allow you to change there environments. It was decided that the groups time would be better used working on the IG, developing the schematron (business rules), and stating the FDA Guidance. There are other ways to create a valid eStability XML file (e.g., XMLSpy, notepad,...).
  • We need supported software for eStability, this probably will not be feasible until FDA sets a date requiring stability data in XML format.

Agenda for April 26, 2010 Teleconference: