Drugmakers

Government warnings have led to plant overhauls, but drug shortages have often been the result.

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BING SEARCH:
  • Innovative Approaches to Sterile Product Manufacturing and ...
    Lapses in quality and process failures can result in severe patient consequences and drug product shortages, adversely affecting public health. The significance of aseptic processing risk is due, in part, to the impact of process failure, difficulty of detection, and lack of clear correlation between measurable parameters and desired outcome.
    12/5/2019 - 3:57 am | View Website
  • Problems of Innovation-Deficient Pharmaceutical Manufacturing
    oversight, quality lapses, and lack of available drugs interact: regulatory actions to ensure compliance with manufacturing-quality regu-lations and prevent quality problems and loss of drug availability can themselves close plants and lead to shortages. To address this interac-tion, the FDA Safety and Innovation Act of
    11/30/2019 - 7:23 am | View Website
  • CONTAMINATION HAPPENS BARRIER USED TO PROTECT YOU CAN’T ...
    BARRIER USED TO PROTECT THE PROCESS IS FAILING Reusable gowns DROP IN BFE OF OVER after laundering and sterilization. 25% 100% of reusable gowns tested SHOWED A DECLINE in BFE after processing. Before Processing After Processing 2 2 are the root cause for microbial contamination in the cleanroom THE TIME PEOPLE PEOPLE ARE THE #1 SOURCE OF CONTAMINATION ˜⁄˛
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    National Drug Shortages and the Medical Toxicologist Brenna M. Farmer, MD Assistant Professor of Medicine Division of Emergency Medicine
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  • Media USA 2004-2015 | Canadian Drug Shortage
    Katie Thomas, Drug makers stalled in a cycle of quality lapses and shortages, New York Times, 17 October 2012. Peter Bach, Leonard B. Saltz, and Robert E. Wittes, In cancer care, cost matters, New York Times, 14 October 2012. Anon. Hundreds seen at risk in meningitis outbreak [linked to shortages] Times Free Press, 4 October 2012. Anon.
    10/18/2019 - 11:30 am | View Website
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