 Richard Bahr MGS President and CEO Visit Website |
Richard has 20 years of experience in management with MGS. He has overseen and directed the building of a growing organization and building of the MGS reputation in the marketplace. Richard has provided key leadership in initiating the development of at least one new product each year since becoming President in 1996. He has sat on multiple industry panels and is frequently sought after for commentary on pharmaceutical packaging automation, most recently regarding compliance packaging formats. He currently serves on the PMMI board of directors.
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Automation Q&A
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Asked March 28th, 2011
Thanks to Joerg Liedtke from Laetus GmbH for helping to respond to questions 1 and 2.
1. Trying to understand future requirements for Serialization on vial label
and outer carton for an IV product….?A: Currently the smallest unit to be serialized is the “unit of sale.” Typically a single vial is not sold, so in your case, serialization would likely need to occur for the carton.
2. When will serialization be required by FDA (Federal) and/or by the state of California?
A: Basically the FDA is currently just starting to define an SNI, see more information at this link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125505.htm#_Toc254967078
The California State Board of Pharmacy enrolled a E-Pedigree law that will become effective in 2015.
Please find detailed information here:http://www.pharmacy.ca.gov/about/e_pedigree.shtml
3. How can this be automated?
A combination of product handling, printing, vision, and IT is required for a complete solution. Firms such as Laetus can provide much of the solution while MGS Machine can provide product handling of the carton as seen here:
http://www.mgsmachine.com/prodvideo.php?id=25&vidid=video1
