HL7 Stability Standard Implementation Guide Teleconference Minutes 2010-03-08

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HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes

March 8, 2010


Norman Gregory (CVM), David Longstaff (CVM), Tim Lee (CBER), Tena Wei (CDRH), Catherine Hosage-Norman (Sepracor), Mike Mlodzik (Fort Dodge Animal Health), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), Jennifer Rice (Alpharma), Lauren Merrill (Genzyme) and Gary Saner (Reed Technology and Information Services Inc.)

  • The Implementation Guide (IG) will have a complete XML example file in the appendix. Will be something simple like tablet.
  • IG will have other XML examples of different types of test that might not be common. Sustained/Controlled Release - multi point dissolution. Ointment - assay at top, middle, and bottom of container. Emulsion/Suspension - viscosity. Aresol - spray pattern, number of actuations, and amount per actuation. Patches - multi point dissolution, patch adhesion, tack (stick), shear (sliding), release liner removal, container integrity, leak test for reservoir (reservoir type patch), and cold creep (matrix type patch).
  • Have been some issued the latest version of Input Tool. The tabs do not display, surrounded by red box and an error message. Reported on two different operating systems (XP and Windows 7) both the professional version.
  • After entering the specification under the “Test Specifications” tab, you have to save and re-open so test will appear under “Test Results” tab.
  • Will give some guidance on Associated Studies and what should studies could be associated (e.g., based on organization of Module 3 of CTD, what data is being pooled). Will be up to the submitter on what they want to associate.
  • “Test Results” tab need a pick list for code (from IG Pause Description).
  • “Test Results” tab need sequence or pause quantity and unit for any level 2 test or higher.
  • “Test Specifications” tab pick list for Interpretation Code.
  • “Product/Substance” tab under Status need to change “Not Established” to “Non Indicating”. Non Indicating could be multiple conditions (e.g., freeze/thaw, photostability) it is not establishing a time but look at performance under varied conditions.
  • The Interpretation Code should determine the date type.
  • Please start trying to use the Input Tool and document any issues. It can be found at https://www.estability.org then click on wiki at top of page and it is at the bottom, file name SMIT0960.zip and the expiration is 6/1/2010. The first time opening will ask for license key that is provided on the wiki. There is also a Word file ”input_tool_observations” that documents other known issues. You need Microsoft.NET framework, version 2 or higher (most current is 3.5) for the Input Tool to work.

Agenda for March 15, 2010 Teleconference: