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Web Sightings
Informative and interesting industry news and views from web sites around the globe.
Talking bottle helps Afghans take their medicine
Medicine containers that talk and give instructions on dosing have been discussed for a long time, but the first systematic application of the technology has come from a somewhat unlikely the source – the US Army.
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Unit-dose Packaging - More regulations may not be necessary
Most efforts to get pharmaceutical companies to convert from bulk or multiple-dose packaging to unit-dose packaging have involved government requirements, like when FDA started requiring unit-dose packaging for iron tablets to minimize the likelihood of an overdose.
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The Push for Modern Manufacturing
Antiquated manufacturing processes cost pharma money-a fact widely known and accepted in the industry. At some facilities, rejected batches, rework, and lengthy investigations have become a way of life, and by some estimates can inflate production costs by as much as 10 percent. According to G.K. Raju, executive director of the Pharmaceutical Manufacturing Initiative at the Massachusetts Institute of Technology, manufacturing consumes an estimated 25 percent of drug company revenues.
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Who Invented Bar Codes? The Irish of Course!
Ogham (pronounced "Ohm") alphabet used by the Irish during the first centuries AD really looks like a form of bar code. Take a look at the font.
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Validation – How it began
Since the Mid-1970s, Validation considerations have played an increasingly dominant role in the manufacture and quality assurance of U.S. health care products. But the origins of validation in the United States goes back to 1906 when the Food and Drug Administration (FDA) was formed in great part in response to, of all things, a book!
The book is called “The Jungle” and it was written by Upton Sinclair. It depicted the brutal conditions that existed in the stockyards and meat markets in Chicago. The conditions it exposed were so bad that the American population cut their meat consumption by over 50%.
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The Evolution of Parenteral Drug Packaging
Newer configurations and materials expand the options for packaging parenteral products.
Prefilled syringes are a fast-growing alternative to conventional glass vials and stoppers for packaging parenteral drugs (see “The Ins and Outs of Prefilled Syringes,” PMP News, May 2003). All prefilled syringes on the U.S. market to date are glass. New plastic alternatives may soon make this packaging approach possible for manufacturers of a wider range of sterile products.
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FDA Issues Final Report on Its “21 st Century” Initiative on the Regulation of Pharmaceutical Manufacturing
Following the second anniversary of the launch of its Pharmaceutical Manufacturing Initiative, the Food and Drug Administration (FDA) today issued a final report that highlights specific steps the agency has taken and will take to develop and implement quality systems management and a risk-based product quality regulatory system.
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