Search results for " pharmaceutical"
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Bioburden Control in the Biopharmaceutical Industry
According to FDA’s definition, an “adulterated” pharmaceutical product is one which is manufactured under non-cGMP conditions. Even if the product itself meets specifications, it is still considered “…
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Continuous Manufacturing: A Changing Processing Paradigm
GlaxoSmithKline, Johnson & Johnson, Genzyme, Bristol-Myers Squibb, AstraZeneca, Samsung BioLogics, and Novartis AG are among the pharmaceutical companies and contract organizations building or expandi…
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Healthcare Reform in China
This move is in line with China’s Opinions on Deepening Pharmaceutical and Healthcare System Reform, whereby the government committed $138 billion between 2009 and 2011. After the plan’s implementatio…
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EMA Collaborates with HTA Assessment Networks
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a new drug is only a preliminary step in what can be a lengthy and complex procedure for some pha…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
As the pharmaceutical industry tries to embrace the methodologies of quality by design (QbD) provided by the FDA’s process validation (PV) guidance (1) and International Conference on Harmonization (I…
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Report from India
Under this new regime, the National Pharmaceutical Pricing Policy 2012 will regulate prices of 348 drugs covered under the National List of Essential Medicines (NLEM) 2011 compared with 74 drugs in th…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
Globally, GS1 works with pharmaceutical manufacturers, wholesalers, distributors, retail pharmacies, hospital dispensaries, trade associations, and regulatory agencies to help advance track-and-trace …
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Drug Quality Key to Innovation and Access
A broad industry group adopted guidelines on using the Electronic Product Code Information Services (EPCIS) for lot-level management and item-level traceability of pharmaceuticals (3). Achieving stand…
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Cleaning of Dedicated Equipment: Why Validation is Needed
By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chiara Parisi, Luisa Stoppa, Isabella Marta
Cleaning of pharmaceutical equipment is essential to reduce the…
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Labeling of Biosimilars
Regulatory issues
Nonetheless, there are a number of regulatory issues with biosimilars that parts of the pharmaceutical industry believe still need to be sorted out by EMA. The biggest of these is…