Regulatory Resources

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).

Contributor: Miss Chanice Henry
Posted: 04/20/2016
Pharma IQ News
 The first quarter of 2016 hosted plenty of activity from the pharma and cold chain industries. This was seen in the form of patent challenges, landmark agreements, extreme market reactions as well as a nationwide medicine ban for hundreds of products. Read on for this quarter’s highlights from Cold Chain IQ & Pharma IQ.Biotech firm sets i Full Article »
Contributor: Chanice Henry
Posted: 04/08/2016
Jeff Cari
Jeff Carrico, Director of Pharmacy - Investigational Drug Service at Florida Hospital System and Member, Expert Committee, Packaging and Distribution, U.S. Pharmacopeia provides an overview of overarching chapters on Good Distribution Practices. Full Video »
Contributor: Andrea Charles
Posted: 04/07/2013
cc_podcasts
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 »
Contributor: Gary Hutchinson
Posted: 09/15/2015
Gary Hutchinson
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 »
Posted: 05/10/2015
New Guidelines Strengthen Good Distribution Practice (GDP)
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 »