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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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Sphere Fluidics receives Queen’s Award for Enterprise
Cambridge, UK, 21 April 2020: Sphere Fluidics, a company commercializing single cell analysis systems underpinned by its patented picodroplet technology, has be honored with a Queen’s Award for Enterprise for Innovation. The award recognizes the Company’s excellence in patenting, developing and globally commercializing single cell analysis systems for biotherapeutic discovery.
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White Papers |
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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
PCI Pharma Services
Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) opened an investigation into a patient complaint of mold on paracetamol (acetaminophen) tablets (1). It discovered the product was shipped by sea from India to multiple companies in the UK at temperatures reaching up to 60 degrees Celsius. Labeling for paracetamol tablets typically states they should be kept below 30 degrees Celsius. In addition, MHRA discovered the humidity levels exceeded 80 percent during shipping, which is too high for the packaging that was used.
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Industry Events |
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World Vaccine Congress Europe
18-21 October 2020, Barcelona, Spain
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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