SMART quality & compliance
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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SMART quality & compliance
Keep Calm and Stay Patient… So Much More Is Coming! -“FDA and the Drug Quality and Security Act”
“Companies spend millions of dollars on firewalls, encryption and secure access devices, and it’s money wasted, because none of these measures address the weakest link in the security chain”. – Kevin Mitnick Drug Quality and Security The problem of counterfeit medicaments and drugs reproduction is one of the major drawback affecting health care systems, patients, and companies worldwide. It is a busting “market” with an estimated worth of 75 billion dollars a year (WHO, 2010). It is fueled by high drugs demand and ease of distribution. Additionally, Internet became a main tool coordinating sales and supply chains of…
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