Search results for " pilot"
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USP Stresses Pharmacopeial Standards at CPhI China
As part of USP’s commitment to the growth of the Chinese pharmaceutical industry, the Convention has built training facilities in the Shanghai Pilot Free Trade Zone. “We will strengthen our collaborat…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Cellbag culture chambers (containers) were manufactured at a Cytiva pilot manufacturing facility in Westborough, MA, US. Gamma irradiation of containers was performed by Steris Isomedix, Northborough,…
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Healthcare Reform in China
The government also kick-started public hospital reform to come up with a mechanism to segregate hospital management and operations, as well as the duties between drug prescriber and dispenser in 16 p…
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Pharma Investments Reflect Key Industry Trends
Novo Nordisk: Novo Nordisk is constructing a $100 million, 29,100-square-foot purification pilot plant at its new research and development facility in Denmark to expand its capacity for early-phase di…
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Global Expansion Shapes Drug Oversight
At the same time, FDA and the European Medicines Agency (EMA) annouced plans to expand their many collaborative programs, including renewal of a pilot program that allows for parallel review and consu…
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Quality by Design—Bridging the Gap between Concept and Implementation
A key issue with design spaces is that they are often developed at a small scale at the laboratory or pilot level. Despite that, design spaces have to show that they match the quality requirements nee…
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Advancing QbD in the EU
The pilot scheme should increase the momentum behind the uptake of QbD principles in Europe among both regulators and pharmaceutical manufacturers as well as lead to a more uniform policy between the …