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).

86 results
of 8
Posted: 13/07/2016
Back in November 2015, I highlighted the new regulations regarding container weight declarations (Verification of Gross Mass or VGM) which came under the International Convention for the Safety of Life at Sea, more commonly known as SOLAS. These were adopted in November 2014 and came into force from 1st July 2016. Full Content »
Posted: 13/07/2016
Pharma Logistics IQ brings you a rundown of the latest updates and newsworthy developments involving the pharmaceutical logistics around the globe. Full Content »
Posted: 15/06/2016
CC US
Ahead of the 14th Cold Chain - GDP & Temperature Management Logistics Global Forum, Cold Chain IQ looks at the concept of global standardization with risk management in the cold chain. This whitepaper explores supply chain security and validation as they pertain to lane qualification, data monitoring, shipping lanes and stability budgets. Full Content »
Posted: 04/05/2016
Cold Chain Logo
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’. Full Content »
Posted: 20/04/2016
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. Full Content »
Posted: 08/04/2016
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 Content »
Posted: 01/03/2016
What’s on the horizon for GMP Compliance
At the recent MHRA GDP & GMP Symposium Martine Powell, GMDP inspector examined the known future for GMP compliance. Full Content »
Posted: 16/02/2016
GDP Compliance Update
In regards to the ever evolving landscape of good distribution practises, Cold Chain IQ has compiled a rundown of the latest updates seen across the globe over the last few months. Full Content »
Posted: 22/12/2015
Your Quarterly Dose of Cold Chain & Pharma News – Q4’s Highlights
The final quarter of 2015 saw a number of high level collaboration announcements in the pharma space, including the highly anticipated potential Pfizer and Allergan merger. Key advancements were spotted with spacecraft intelligence being pinpointed as one of the latest technologies to propel the cold chain market after it was used to support the ebola vaccine candidates in Sierra Leone.

Here Cold Chain IQ presents the industry’s highlights for this quarter. Full Content »
Posted: 15/09/2015
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 Content »
Posted: 10/05/2015
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 Content »
86 results
of 8
Posted: 08/04/2016
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 »
Posted: 07/04/2013
Cold Chain podcast
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 »
Posted: 13/07/2016
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Back in November 2015, I highlighted the new regulations regarding container weight declarations (Verification of Gross Mass or VGM) which came under the International Convention for the Safety of Life at Sea, more commonly known as SOLAS. These were adopted in November 2014 and came into force from 1st July 2016. Full Column »
Posted: 15/06/2016
CC US
Ahead of the 14th Cold Chain - GDP & Temperature Management Logistics Global Forum, Cold Chain IQ looks at the concept of global standardization with risk management in the cold chain. This whitepaper explores supply chain security and validation as they pertain to lane qualification, data monitoring, shipping lanes and stability budgets. Full Whitepaper »