Regulations can differ from country to country, making international shipping complex. Accountability may lie with the QP, but it's the responsibility of all supply chain stakeholders to implement compliant supply chain processes and help their company adhere to Good Distribution Practices (GDP).
China’s State Council has passed an amendment on vaccine regulations just weeks after the launch of an investigation into incorrectly handled vaccines took place, in ‘a case that shook the country’. The amendment, which impacts multiple articles within Regulations for the Circulation and Inoculation of Vaccines, was passed on April 24th.Cold c Full Article »
Leon Dzivinsky Vice President & Senior Legal Counsel of PRA Health Sciences talks to Cold Chain & Pharma IQ about Clinical Trial Supply Trends in Russia, Ukraine and Belarus. Full Video »
Jacques Dysli, Partner at Supply Chain Operations SA, talks to Andrea Charles from Cold Chain IQ, about current tactics for achieving supply chain integrity and data visibility for risk mitigation, the hottest topics in the temperature controlled supply and how the new GDP guidelines are impacting controlled rooom temperature( CRT) logistics and Full Podcast »
Process validation for cold chain logistics (packaging, storage, and distribution) is a required part of the Common Technical Document (CTD) for any Biologics License Application (BLA) for monoclonal antibodies. Any review of the submitted dossier and subsequent pre-approval inspection onsite will most likely review the following areas Full Column »
This white paper is designed to provide an overview of the recently introduced EU Guidelines on the Good Distribution Practice (GDP) of Medicinal Products for Human Use and the significant new demands placed on the manufacturers and distributors of pharmaceutical products. Partly driven by the need to prevent counterfeit and falsified medicines from entering the legitimate supply chain. Full Whitepaper »