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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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Destiny Pharma appoints MedPharm to develop new XF-platform drug formulations
Destiny Pharma, a clinical stage biotechnology company focused on the development of novel antimicrobial drugs, is pleased to announce that it has appointed MedPharm as its expert partner to develop new topical formulations of the Company’s novel XF-platform compounds. These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti-microbial resistance (AMR). MedPharm is a world leading contract provider of topical and transdermal product design and formulation development services using sophisticated in vitro models to de-risk development programmes.
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White Papers |
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7 Common Myths about QP Training Debunked: A Guide for Senior Managers
RSSL
The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
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Industry Events |
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CPhI Worldwide
5-7 November 2019, Frankfurt, Germany
Join the World's Largest Pharma Event As it Celebrates its 30th Anniversary!
Taking place from 5-7 November 2019 in Frankfurt, Germany, the event
will bring together more than 45,000 visiting pharma professionals from
around the globe and over 2,500 exhibiting pharma companies from every
stage of the pharmaceutical supply chain - from ingredients and
machinery to outsourcing services, packaging and more!
More info >> |
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