samedan logo

 
 
spacer
home > white papers > EU GDP Guidelines: Implications for Shipping Clinical Materials into the European Market - PCI Pharma Services
WHITE PAPERS
logo_PCI_PharmaL.jpg

PCI Pharma Services

phone +44 (0)1495 713 633
email sales@pciservices.com
web http://www.pciservices.com
email Wye Valley Business Park, Hay-on-Wye, HR3 5PG

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
spacer

Member login

E-mail address:

Password:
Remember me


News and Press Releases

Ready for Business: PPMA Show 2021

Countdown begins to first UK live event for the processing and packaging industry. In a few weeks’ time, PPMA Show 2021 will return to the NEC Exhibition Centre in Birmingham, from September 28th-30th. As the first major PPMA live event since September 2019, following the postponement of all live events in 2020 and early 2021 due to the COVID pandemic, exhibitors and visitors are getting ready to do face-to-face business. With a focus on supporting the processing and packaging communities with sustained business recovery following the challenges of the last year, PPMA Show 2021 will bring together over 250 exhibiting companies, offering businesses a long-overdue opportunity to see emerging technologies and explore the latest trends in the industry.
More info >>


White Papers

Biosimilars In Emerging Markets: Is It A Level Playing Field?

PRA Health Sciences (PRA)

Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
More info >>


Industry Events

Pharma Integrates 2021

16 November 2021, VIRTUAL CONFERENCE

Now in its tenth year, Pharma Integrates is a unique event bringing together pharma and healthcare leaders across the Pharmaceutical pipeline to address their needs, to share insights and create debate on crucial topics that influence the future of patient outcomes.
More info >>


©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement