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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SMART quality & compliance
The Supply Chain – the Backbone of a Pharma Company! -Track&Trace
“Heroes may win battles, but it is capable supply chains that win wars” – Natalie Privett Many firms have been trying to discover, develop and market medicine more economically and efficiently. Unfortunately, relatively little effort was given on reconfiguring their manufacturing and distribution operations. Most pharmaceutical corporations have complex supply chains that are under-utilized and unproductive. In fact, they are badly equipped and unable to cope with the products coming down the pipelines. To see the weaknesses of distribution structure, companies have to possess a record of every single component that manufacturer uses, information about manufacturing processes, delivery systems of…
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