HL7 Stability Standard Implementation Guide Teleconference Minutes 2009-11-02
HL7 Stability Standard Pilot/Implementation Guide Teleconference Minutes
November 2, 2009
Norman Gregory (CVM), Elizabeth Cormier (CVM), David Longstaff (CVM), Tim Lee (CBER), Terry Hardin (Perfitech), Catherine Hosage-Norman (Sepracor), Paul Tenaglia (Apotex), Mike Yang (ScienTek Software), Edward Pec (Abbott Laboratories), and Diane Miller (Alpharma)
- BatchIngredient - This is to capture the active ingredient(s), the manufacture of the active(s), and lot number(s) used for that lot of product being reported.
- IG change - Quantity for BatchIngredient needs to be changed from R to O for FDA requirements.
- In the IG some of the attributes in the XMLSpy snippets have dash boxes around them. Originally suggested to try ad remove the attribute and dash box from snippet, after discussion was determined that the IG should have a detailed description (use and functionality) of the attribute in the dashed box.
- User Guide needs to explain the information need for ManufacturedMaterial if it is a product or substance and what is required and what is required if coming from the BatchIngredient (e.g., if ManufacturedMaterial is for substance, BatchIngredient can be left blank because it is optional). Since ManufacturedMaterial also points to Manufacturer and Container, BatchIngredient will point to them too.
- StyleSheet - Container/Closure Description: how you can have a link.
- StyleSheet - Drug Substance - Lot/Batch Numbers - Manufacturing Sites: name of active is from text description, will only display town and state, not street address, information can be captured.
- If you want the Stylesheet to display the box with the replicate results, RSD, and average copy the file “testComponent.htm” from one of the previous versions of stylesheet.
- The interactions in the message are PORT_IN090001UV10 (report), PORT_IN090002UV10 (revision), and PORT_IN090003UV10 (retraction) and they are valid.
- Attached is a Word document “eStability Input Tool - Input Screen Tips.doc”. Please take a look at it for discussion at next teleconference.
- The Input Tool is ready for testing. 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 SMIT0942.zip and the expiration is 1/1/2010. 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 November 9, 2009 Teleconference:
- We will continue to use Adobe connect (to join the meeting: https://collaboration.fda.gov/hl7/).
- Discuses the attached document “eStability Input Tool - Input Screen Tips.doc”.
- Looking at Input Tool using Adobe connect to work on what information to put in help fields.