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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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