SMART quality & compliance
The clock is ticking! From planning to execution: e-pedigree and serialization
“The price of no action is far greater than the cost of a mistake” ― Meg Whitman FDA regulations… State governments, federal agencies and the pharmaceutical industry started a real war against counterfeiting and diversion. Track and trace system, serialization, and e-pedigree are their main defensive tools. The desperation and perseverance have been additionally stoked after FDA’s recall-data publication. In middle of 2014, presented statistics have suggested the highest amount of serious drug recalls in history (FDA, 2014). Unprecedented surge in the number of deviations reported to the agency whetted the tension among manufacturers and caused implementation of additional regulations…
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