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Nouveautés Web
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Packaging and Labeling of Finished Bulk Pharmaceutical Chemicals
(a) Sound procedures must be employed to protect the quality and purity of the BPC when it is packaged and to assure that the correct label is applied to containers.
Labeling for containers of BPCs is subject to all applicable provisions of 21 CFR, Parts 200 and 201. In case questionable labeling is encountered, collect samples of the labeling for submission to the appropriate Center(s) for review.
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Lean Pharmaceutical Program
Event Description:
The Pharmaceutical industry is facing great changes. The current challenge of high-speed reliable delivery combined with growing regulation and price pressures makes this a time when all pharmaceutical companies must become lean or cease to exist.
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World Pharmaceutical Packaging to 2009
This study analyzes the $22.3 billion world pharmaceutical packaging industry. It presents historical demand data (1994, 1999, 2004) and forecasts to 2009 and 2014 by raw material, by product (e.g., blister packs, pouches and strip packs, prefillable syringes, medication tubes, parenteral vials and ampuls, prefillable inhalers, IV containers, bottles and jars, caps and closures, secondary boxes, prescription containers); by world region and for 26 countries.
The study also considers market environment trends and indicators, evaluates company market share and profiles 37 leading industry participants including Alcan, Amcor, Cardinal Health, MeadWestvaco, SCHOTT Pharmaceutical Packaging, Gerresheimer, Owens-Illinois, and Becton Dickinson.
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FDA Rule Requires Bar Codes on Drugs and Blood to Help Reduce Errors
As part of a wide-ranging effort to improve patient safety, on Feb. 25, 2004, FDA finalized a rule requiring bar codes on the labels of thousands of human drugs and biological products. The measure aims to protect patients from preventable medication errors by helping ensure that health professionals give patients the right drugs at the appropriate dosages.
The bar codes -- similar to those on food packages and other consumer goods will be required on most prescription drugs and certain over-the-counter drugs. The rule also requires machine-readable information on container labels of blood and blood components intended for transfusion.
FDA estimates that the rule will help prevent nearly 500,000 adverse events and transfusion errors while saving $93 billion in health costs over 20 years.
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