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GMP - GOOD MANUFACTURING PRACTICES |
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Good Manufacturing Practice is a set of regulations, codes, and guidelines for the manufacture of drugs (known as medicinal products in Europe), medical devices, diagnostic products, foods products and Active Pharmaceutical Ingredients (APIs).
Since sampling products will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the production and laboratory testing environment itself. An extremely important part of GMPs is documenting every aspect of the process, activities, and of operations. If the documentation is not correct and in order, showing how the product was made and tested, that allows for traceability, and recall from the market in the event of future problems, then the product is considered contaminated (in the US considered adulterated).
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STROKE |
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A stroke, also known as cerebrovascular accident (CVA), is an acute neurologic injury whereby the blood supply to a part of the brain is interrupted, either by a clot in the artery or if the artery bursts. The result is that the part of the brain perfused by that artery no longer can receive oxygen carried by the blood and it dies (becomes necrotic) with cessation of function from that part of the brain. In addition to tissue death, hemorrhages also cause damage from physical impingement of blood on the brain tissue. Stroke is a medical emergency and can cause permanent neurologic damage or even death if not promptly diagnosed and treated. It is the third leading cause of death and adult disability in the US and industrialized European nations (Jauch, 2005).
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