SMART quality & compliance
Patient safety first – a new EU directive to protect public health from falsified medicines
By Asemi – By our camera, CC BY-SA 3.0, Link “It is health that is real wealth and not pieces of gold and silver.” Mahatma Gandhi Imagine you have a bacterial infection and require therapy using antibiotics. Instead of obtaining the antibiotics and dosage you require, you receive substandard or falsified medicine, which for various reasons does not ease your infection or has previously non-described side effects on your health. While you might feel like this is a cautionary tale to raise your awareness for the fact that falsified medicines exist, this is a real-life problem which has become more…
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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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