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| home > white papers > The Impact of Components on Drug Quality and Risk Mitigation - West Pharmaceutical Services, Inc. |
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 WHITE PAPERS |
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West Pharmaceutical Services, Inc.
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The Impact of Components on Drug Quality and Risk Mitigation
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Expectations for quality by regulatory agencies are increasing at a very
fast pace, especially for prefilled drug delivery formats, thanks to
increased focus on reducing risk to patient safety. The trend has
resulted in delays for new drug applications, more recalls of marketed
products and even drug shortages if the container system and drug
contents are suspect for quality issues. The pharmaceutical market is
now requiring manufacturers of containers and components to meet new
expectations with a quality culture and very high product reliability.
The need to bridge the gap and provide superior quality products has
been a driver for manufacturing technology investments, more robust
control strategies and the introduction of next generation elastomer
components.
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News and Press Releases |
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New Report Introduces Benchmarks on Clinical Trials Vendor Qualification Process
PRINCETON, NJ – A new report from Tufts Center for the Study of Drug
Development establishes benchmarks for the vendor qualification process,
a critical element of clinical trial set up and execution. According to
its November/December Impact Report, the process volume and complexity
of the vendor qualification process creates delays in initiation in 7%
of clinical trials for biopharma sponsors and 14% of trials for Contract
Research Organizations.
More info >> |
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White Papers |
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The Power of Execution in Clinical Research
Medpace
Medpace, long known for its excellence in conducting Phase I-IV studies
on a global platform, is particularly noted for its therapeutic
excellence. When that expertise is combined with operational precision,
the results are nothing short of stellar. The Medpace full-service
outsourcing approach – combined with therapeutic expertise, regulatory
know how, and global presence – delivers clinical studies with an
industry recognized track record.
More info >> |
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Industry Events |
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INTERPHEX 2020
28-30 April 2020, Javits Center NYC
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