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| home > white papers > EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market - PCI Pharma Services |
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 WHITE PAPERS |
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PCI Pharma Services
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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
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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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News and Press Releases |
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Ardena expands capacity to satisfy Novavax COVID vaccine demand
Gent, Belgium/December 2021: Ardena, a specialist pharmaceutical
contract development and manufacturing organisation (CDMO), announced it
will be expanding its capacity for purification and fractionation of
GMP manufacturing at its site in Södertälje, Sweden. The expansion will
satisfy long-term demand expected from Novavax for production of the
company’s COVID-19 vaccine, among others.
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White Papers |
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Assessing the Integrity of Pharmaceutical Packaging Using the Sepha Blisterscan and Conventional Blue Dye Leak Testing Methods
Sepha Limited
A new whitepaper by a leading packaging expert from the University of Ulster, Dr Dorian Dixon, into the integrity of pharmaceutical packaging has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer, technology based test equipment.
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