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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 renewed Turkish Cargo Web Portal now offers you many conveniences with its new name ‘TK GO’
Turkish Cargo, the fastest-growing brand of the global air cargo industry, updated its web portal; a functional and user-friendly interface on Internet facilitating monitoring of all actions and providing the agents with customized solutions and facilitations.
More info >> |
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White Papers |
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Extractables and Leachables Testing: A Risk Based Approach
RSSL
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient. Extractables and leachables (E&L) studies therefore play an important role in verifying the safety of a drug product over its lifetime.
Regulatory organisations such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) are taking an increased interest in the interactions of various drug delivery devices, pharmaceutical product containers and medical devices with drug product and/or patient and this field is therefore growing in importance.
Regulatory guidelines indicate that an extractables profile should be determined for all materials that contact the drug product. Once established, this profile can be used to determine whether any of these extractables are present as leachables within the product. If a leachable is detected, amounts can be determined using validated analytical methods, after which a biological risk can be established based on the exposure.
This white paper will provide an overview of the processes used to determine extractables and leachables from plastics.
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Industry Events |
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Pharmapack Europe 2020
5-6 February 2020, Paris Expo, Porte de Versailles - Hall 7.2 | Paris, France
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