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
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Contributor: Mark Edwards
Posted: 07/13/2016
Mark Edwards
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.This article gives an overvie Full Content »
Contributor: Cold Chain IQ News
Posted: 07/13/2016
Cold Chain IQ News
Pharma Logistics IQ brings you a rundown of the latest updates and newsworthy developments involving the pharmaceutical logistics around the globe. Updates include new regulations, discoveries and reports of non compliance with GDP. Seafreight Weight Regulations come into effectNew regulations regarding container weight declarations (Veri Full Content »
Contributor: Cold Chain IQ
Posted: 06/15/2016
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 »
Contributor: Miss Chanice Henry
Posted: 05/04/2016
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’. The amendment, which impacts multiple articles within Regulations for the Circulation and Inoculation of Vaccines, was passed on April 24th.Cold c Full Content »
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 Content »
Contributor: Miss Chanice Henry
Posted: 03/01/2016
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.Martine Powell GDMP Inspector discussed upcoming deadlines for the GMP industry. These included GMP for excipients – which is due to come into effect in March 2016, the documented update to Annex 16 – coming into effect in April 20 Full Content »
Contributor: Miss Chanice Henry
Posted: 02/16/2016
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.New Russian GDP Guidelines Activate Guidelines on Good Storage and Transportation Practice of Medicinal Products for Medical use from the Russian Ministry of Health came Full Content »
Contributor: Miss Chanice Henry
Posted: 12/22/2015
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 eb Full Content »
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:• Stability Full Content »
Posted: 05/10/2015
New Guidelines Strengthen Good Distribution Practice (GDP)
This new 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 Full Content »
86 results
of 8
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: Mark Edwards
Posted: 07/13/2016
Mark Edwards
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 »
Contributor: Cold Chain IQ
Posted: 06/15/2016
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 »