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Stricter… Harsher… Narrower…? GMP guide improvement of best practices in the area of Quality
The pharmaceutical industry is a highly regulated and controlled sector of economy. Development, manufacturing, and management of medical products are carefully examined and analyzed in order to ensure amenability with present requirements of safety, quality and efficacy. European Union authorities ensure that all medical products on the European market are manufactured or imported by authorized producers or approved partners. All activities regarding manufacturing, repacking, transporting, and so on are described in the GMP guidelines. It ensures that goods are consistently made and controlled according to updated standards. In addition it minimizes the risks tangled in any medicinal production that cannot…
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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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