Regulations
How do you ensure your company is fully compliant on an international level? As one of the most heavily regulated industries in the world, it is pivotal that you stay up to date with the latest legal changes in the pharmaceutical industry. Whether it’s regulation in the EU, United States, Russia, India or anywhere in between, we cover it all through a wide range of resources, including timely news updates, analysis, reports, infographics and videos.
A Process Validation Guide for Cold Chain Logistics
September 16 by Gary HutchinsonProcess 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...
Don't Let Your Future Be Frozen Out
August 11 by Pharma Logistics EditorUndoubtedly, the supply chain is complex to navigate with the maintenance of quality and security being of prime focus. New compliance requirements have translated into additional expenses for cold ch...
Avoiding The Prospect of Broken Cold Chains
July 29 by Pharma LogisticsCold Chain IQ speaks to Nigel Wing, Global Head Life Sciences & Healthcare, DHL Global Forwarding on avoiding the prospect of broken cold chains and the importance of the industry remaining focuse...
A Complete Guide to the Cold Chain Open House 2015
July 19 by Pharma Logistics EditorFollowing the success of last year we are proud to announce the return of Cold Chain Open house! Over 400 temperature controlled logistics professionals gathered last year to listen to the latest case...
Lane Qualification VS Continuous Monitoring 2015 Report
July 07 by Pharma Logistics EditorPharmaceutical Supply is laced with stringent control requirements.In this highly regulated space, suppliers must ensure "…medicines are obtained from the licensed supply chain and are consistently st...
Life Sciences Needs Smarter Cold Chains: The Four Essentials
June 23 by Pharma LogisticsIn response to its new research DHL Global Forwarding has signaled the need for a new generation of cold chains to be developed for the life sciences and healthcare industry in order to aid global hea...
Save Time and Money in Your Cold Chain via Dynamic Stability Testing
June 15 by Gary HutchinsonStability testing outlined in the ICH guidelines primarily addresses the establishment of expiry dating and storage conditions. Temperature-sensitive product may exceed long-term storage conditions es...
New Guidelines Strengthen Good Distribution Practice (GDP)
May 10 by Pharma Logistics EditorThis 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 dem...
Regulatory Growing Pains Heat Up Cold Chain
April 28 by Pharma Logistics EditorBiologics companies face a unique paradox. Inconsistent regulations surrounding their in-transit production one hand, and a Byzantine shipping process on the other, result in clinical delays, and ulti...
Cool Chain Europe 2015 - Awards & Summit Highlights
April 21 by Pharma Logistics EditorWatch the key highlights from the 14th Annual European Temperature Controlled Logistics Summit, Europe’s biggest and longest-running gathering of life sciences logistics, supply chain & QA profess...
How will New GSP Requirements affect China’s Cold Chain Market in 2015?
March 25 by Pharma Logistics EditorTime is ticking for China’s pharmaceutical and logistics companies to modernise and comply with the new Good Supply Practice (GSP) regulations. Yet this is easier said than done due to the complexity...
GDP Implementation in Russia, Belarus and Kazakhstan
March 18 by Mikhail KhazanchukFor long years pharmaceutical industry in Russia has been awaiting implementation of GxP-practices as a legally binding requirement. Start was given at the end of 2013 when GMP was officially put in f...