Meeting+Minutes+Mar-18-09+DL&ER+Workgroup


 * 1. Export Only Products:**

Discussions continued again around Drug Listing of Export Products. There is still some uncertainty on how to procede. FDA is looking into the issue. It seems as though one of the issues is around interpretation of the regulations. One of the individuals on the team will contact the DRLS office to get some insight into this issue. Follow up will be at the next meeting.


 * 2. Solid Dosage Product Image:**

Solid Dosage Product images were discussed. Without more insight as to the process, a proper assessment may not be possible. The process is currently understood that product would be sent to NLM, it would be scanned and a jpg of the image would be sent back to the sponsor to include in the SPL file. The one concern that surfaced was regarding synchronization of the marketing application with the spl file. If there are changes in the formulation of the final product, the image on DailyMed may not be in line with the image of the product being marketed and in the application. This is a relatively infrequent event, so there was not much concern about this. Once more details are available, the team will be ready to discuss further.


 * 3. Wiki Survey:**

The Wiki Survey on SPL r4 is available at the following location: http://spl-work-group.wikispaces.com/Industry+Survey

Only a handful of individuals have taken the survey. There is a great amount of information within the survey and it can prove to be very useful if more individuals participate. In reviewing the survey, it appears that there seems to be a large group falling into many of the same categories. Members of this workgroup will take the survey. A suggestion was made to add more questions. One question that was suggested was: Are you using or will be using XForms to create SPL r.4. Are you outsourcing creation of SPL r.4 or do you have an interim solution such as outsourcing in the shortterm and developing software for the long term?

One of the team members was having an issue converting SPL r3 files into new r4 files because the vendor could not enter the Set ID from the r3 files into the r4 files. This is resulting in manual work from many of the files that will need to go into r4. Others on the call were not having this issue and it seems that this is a specific issue with the software the vendor is using. It would help many on the team to adress some of the issues they are having so that all can streamline their process.
 * 4. Vendor Issues**

There are many scenarios that individuals are having issues identifying whether a validation would occur as a result of. These includes the following:
 * 5. Validation issue - case study**
 * Discontinuation of manufacturing of a product and maintaining the SPL r4 file until last lot has expired. There will be no establishment if it is deregistered. Is this a validation issue?
 * If there is no DL data but file still exists and there is no product on the market. SPL file will be used for registration in other countries. (follow up with FDA gives following response: Send in waiver to review division to eliminate spl requirement for products that are no longer marketed)
 * API bulk product needed for drug listing but has no Content of Labeling.

Team discussed creating a Validation Case Study document to address these issues and have them posted on Wiki


 * 6. Next meeting - April 1, 2009 at 1 PM Eastern Time.**