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EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market

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.
EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market
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News and Press Releases

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

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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