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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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3P Biopharmaceuticals and Nordic Nanovector have extended partnership for Betalutin® late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment
The non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system
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White Papers |
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Quality By Design
Biopharma Group
Quality by Design (QbD) is a systematic approach to development that begins with the defined objectives and emphasizes science and quality risk management in order to achieve those goals. QbD ensures that the quality of the product is built into production processes from the outset, rather than being tested after development has already commenced.
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Industry Events |
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BioTrinity 2020
28-29 April 2020, Digitally delivered
BioTrinity is a long-running and highly regarded two day life sciences conference that takes place in Central London from 28-29 April. BioTrinity focuses on partnering, investment and collaboration and aims to inspire growth and create opportunities for all who attend. The core delegate mix includes early-stage and emerging biotech, medtech and digital health companies, big pharma executives and life sciences investors.
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