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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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The need for a blueprint emergency plan to avoid a HPAPI crisis
SMi reports: Taro Pharmaceuticals, Purdue Pharma and Sakari Consultants
to present at HPAPI USA taking place on October 21st – 22nd in Boston
More info >> |
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White Papers |
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Igb Tamper Evident Folding Box
IGB
The easiest, safest and less expensive solution in compliance with what requires Dir. 62/2011/EU, FDA and TGA.
More info >> |
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Industry Events |
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CPhI Korea
21-23 August 2019, COEX, Seoul, South Korea
CPhI Korea provides a dynamic meeting place for a wide range of industry
suppliers to engage with purchasers and decision makers from the
pharmaceutical industry in Korea and the surrounding region. The exhibition
showcases the whole pharma supply chain from ingredients, contracting services
to machinery and biopharmaceuticals. It also hosts an extensive conference
programme covering the latest trends and topics within the regional market.
More info >> |
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