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Global Supply Chain Insights

Cathy

TOP 10 US Pharmaceutical Ocean Imports:

One large pharmaceutical manufacturer’s transportation split is now 60% ocean. Besides the obvious lower costs why else would pharmaceutical manufacturers use a mode of transport that is so much slower?

by: Cathy Roberson
Published: November 3, 2016
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Cathy

The Greening of the Cold Chain:

Sustainability has become a buzz-word throughout the logistics space but it seems it has a variety of interpretations. It can range from using renewable resources in production, reducing energy use in operations, waste-reduction and more. The pharmaceutical industry is certainly no stranger to sustainability and is in fact facing mounting pressure from the public and governments to reduce its environmental impact. However, its dilemma may be considered a bit different from pressures that other industries are facing. For example, the pharmaceutical industry must balance safety standards while improving its environmental impact.

by: Cathy Roberson
Published: September 7, 2016
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Cathy

3D-Printed Pharmaceuticals & their impact on the Cold Chain:

Imagine, a doctor sends a prescription to a pharmacy that uses a 3D printer to create a custom formulation based on the special needs of a patient or perhaps a patient is able to print his own medications from home with raw materials purchased at a pharmacy or who knows, delivered via drone or by an autonomous delivery truck. This futuristic outlook involving cost shifting to the patient is not likely to occur soon. The requirement of purchasing a printer and raw materials could be prohibitive for many. It also would raise numerous quality control and regulatory questions.

by: Cathy Roberson
Published: July 27, 2016
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Cathy

The Expanding Sensor:

The sensor is advancing beyond the containers and packages and is leading the Internet of Things wave to such areas as wearables to implantables, smart homes to smart cities. The pharmaceutical industry will benefit greatly from such advances and will further usher in the digital healthcare discipline. Imagine the supply chain implications.

by: Cathy Roberson
Published: June 15, 2016
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Global Cold Chain Connections

Gary Hutchinson

Top 3 Battlefields: Active Vs. Passive Shipping Containers:

When it comes to active versus passive shipping containers, the top three considerations when determining which is best for your cold chain network are (1) total delivered cost, (2) product requirements, and (3) equipment availability. In the active refrigeration market, the competition is improving,

by: Gary Hutchinson
Published: September 14, 2016
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Gary Hutchinson

Case Study: Meeting Cold Chain Logistics Challenges In Global Clinical Trials :

Clinical trial material (CTM) or investigational medicinal products (IMP) are an important part of the early stages of the life science supply chain. As trials are being run on a global scale, in markets with less than ideal infrastructure, there is a dire need for companies to work with specialized cold chain experts to engineer and design innovative distribution processes. Cold chain failure may lead to: the patient being administered an unsafe product; liability based on compliance infractions; inconsistent data results; or an entire shipment’s product integrity could be rejected by the quality department, resulting in costly delays.

by: Gary Hutchinson
Published: June 29, 2016
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Gary Hutchinson

It is Never Too Late to Document Your Cold Chain Process Validation Approach:

Documentation strategy for your cold chain management validation practices has evolved over the last several years. The FDA and other regulatory agencies are requesting more and more specific information in the filing to confirm the impact to drug product during transport, and the effect transportation hazards have on shelf life.

by: Gary Hutchinson
Published: May 24, 2016
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Gary Hutchinson

A Potential Revolution For Passive Shipper Selection :

The selection process of passive shippers intended to maintain a specified range of temperatures from the point of origin to the destination has become increasingly complex with the introduction of stronger regulatory requirements and continued advances in technology.

by: Gary Hutchinson
Published: April 20, 2016
Tags: cold chain, temperature controlled logistics, GDP Cold Chain Global Forum,

Logical Logistics

Mark Edwards

Seafreight Container Weight Regulations– Update:

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.

by: Mark Edwards
Published: July 13, 2016
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Mark Edwards

3 Key Tactics to Accurately Track Success:

Cold Chain IQ Columnist Mark Edwards explores the key measures needed to evaluate, and later enhance, a business's performance.

by: Mark Edwards
Published: May 31, 2015
Tags: Mark Edwards, Key Performance Indicators, KPI, On Time Service Performance, Efficiency measures

Mark Edwards

Temperature Controlled Airfreight:

Since the introduction of "new" Good Distribution Practice (GDP), there has been a lot of work by airlines to introduce temperature controlled services. There are currently more than 30 airlines who offer a "pharmaceutical" service but not all services are created equally!

by: Mark Edwards
Published: April 9, 2015
Tags: Temperature Controlled Airfreight, air freight, Mark Edwards, airlines, Good Distribution Practice, GDP, temperature controlled services

Making Tomorrows Medicines

Tony Hitchcock

A More Balanced Understanding Of “Risk”:

Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and still seems to be a long way from a consensus between various end users and manufacturing bodies on how to address this issue.

by: Tony Hitchcock
Published: May 16, 2016
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Tony Hitchcock

A More Balanced Understanding Of “Risk”:

Earlier this year I was fortunate enough to attend the Disposable Solutions meeting in Munich. A common theme of discussions was the on-going debates around the issues of leachable and extractables and the associated testing standards. This is a topic that has been debated for as long as I have been attending meetings on single use systems, and still seems to be a long way from a consensus between various end users and manufacturing bodies on how to address this issue.

by: Tony Hitchcock
Published: May 16, 2016
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Stay Cool with Jim Bacon

Jim Bacon

The Human Side of Lane Qualification – The Mock Shipment Call:

Wouldn’t it be great if roles and responsibilities by all parties involved in a shipment were completely understood and agreed to? All too often, an excursion can be attributed to some form of human error and more often than not this occurs during a transfer or hand-off from one service provider to another. I have addressed this issue in many presentations over the past many years, referring to it as "the weakest link". Shippers that improve these hand-offs through robust and disciplined process steps and improved agreements with providers have mitigated their risk by securing "stock throughput coverage" insurance which provides continuity coverage for shipments. This however does not eliminate the risk, so extra steps and a continuous loop of review is required.

by: Jim Bacon
Published: January 5, 2016
Tags: cold chain, Jim Bacon, mock shipment call, lane qualification, lane validation, supply chain. temperature control

Jim Bacon

The Cold Chain Global Forum – what’s in it for me?:

Dear readers and colleagues in the Pharma Cold Chain arena, I am pleased to be initiating a regular article with Cold Chain IQ, discussing the issues, challenges, and opportunities of shipping temperature sensitive pharmaceuticals and biotechnology products throughout the cold chain from manufacturer to end-customers. As many of you know, I will draw from my many years of experience and provide my thoughts and ideas from a manufacturer-logistics perspective in laymen’s terms that make sense to the novice and / or the advanced practitioner. Over the years I have stayed true to my core principles of maintaining product integrity, understanding the value of the partner provider relationship, promoting transparency of information, and the overriding notion that "the whole is greater than the sum of its parts".

by: Jim Bacon
Published: September 15, 2015
Tags: cold chain, global forum, temperature controlled logistics, GDP. Jim Bacon, Grifols, stay cool with jim bacon, cost efficiency

Biologistic Insights

Eugenio Filippi

Selecting high quality suppliers:

A couple of interesting quotes I have recently seen in cyberspace made me muse.Although not new, they are certainly evergreens, such as the famous "the bitterness of poor quality remains long after the sweetness of low price is forgotten" by Benjamin Franklin (1706 – 1790) which hits the nail on the head as far as supplier selection in the pharmaceutical industry goes.

by: Eugenio Filippi
Published: June 1, 2015
Tags: cyberspace, supply chain, Eugenio Filippi, Supplier selection, cold chain suppliers

Eugenio Filippi

Your Risk Assessment is Only as Good as Your Due Diligence:

Personally, the more interesting topic is the Risk-based approach which is starting to become more and more predominant in the industry, albeit some years after the regulators first defined this concept.

by: Eugenio Filippi
Published: March 8, 2015
Tags: Eugenio Filippi

Cold Chain Corner

Kevin Kohleriter

The Standards Myth: Why Temperature Controlled Packaging Fails And What You Can Do About It:

What if I told you that not all standards are created equal. Some are just flat out confusing and some are just unfinished at best. In an ongoing effort to create a global standard, the reality is that those standards have created a baseline, not a target. So how do we get from a baseline to a target? Let’s start with that baseline and work our way through its flaws, how to remediate those flaws, and the steps to take to get past that baseline and closer to a cost effective, protective, and green friendly solution.

by: Kevin Kohleriter
Published: April 14, 2015
Tags: Kevin Kohleriter, cold chain corner, Temperature controlled packaging, packaging, standards, global standards

Manufacturing and Distribution practices in Eurasian Economic Union

Mikhail Khazanchuk

GDP Implementation in Russia, Belarus and Kazakhstan:

For 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 force in the country based on EU adopted guides.

by: Mikhail Khazanchuk
Published: March 17, 2015
Tags: GDP Implementation, Russia, Belarus, Kazakhstan, GDP draft, Mikhail Khazanchuk

Insulated and Cooling Packaging Insights

Sofrigam Editorial

An Insulated Shipping Packaging Solution Perfectly Stable for 240 Hours:

The most commonly used insulations in manufacturing insulated shipping packaging solutions are polyurethane, expanded or extruded polystyrene and polyethylene. With thermal conductivity at 20 and 25mW/m.K, PU produces the best thermal performance in traditional insulation. Combined with eutectic gel panels at 0°C, PU boxes provide up to 5 days autonomy between +2 and +8°C, compared to only 3 days for others.

by: Sofrigam Editorial
Published: June 24, 2014
Tags: insulated shipping packaging, insulations, pharma shipping, packaging, SOFRIGAM

Sofrigam Editorial

Qualification or Validation of a Cold Chain Shipping Solution?:

Each logistics circuit has its own constraints. These constraints are even more important when transporting heat sensitive pharmaceuticals. In fact, the laws and regulations associated with the transport of heat-sensitive products have become stricter over the last few years. Theses changes are leading to more precise specifications and thus, to highly secured cold chain shipping solutions.

by: Sofrigam Editorial
Published: June 5, 2014
Tags: cold chain shipping, logistics, cold chain shipping solution, customer logistics circuit, SOFRIGAM

Sofrigam Editorial

Insulated shipping packaging - The Specifications Document, a guarantee of respected quality:

The ideal insulated packaging solution would meet quality and productivity requirementsin terms of performance, ergonomics and ease of preparation, logistics issuesin terms of weight and volume optimisation, and satisfy budgetary constraints. This is all well and good, but each user has its own vision of the ideal insulated packaging solution. The specifications document’s role is to match the user’s expectations with the supplier’s recommendations.

by: Sofrigam Editorial
Published: January 12, 2014
Tags: insulated shipping packaging, good cold chain management, specifications document, temperature-controlled packaging, SOFRIGAM

American Airlines Cargo Business Insights

Tom Grubb

Rigorous Realities – Enhanced Expectations in the Air Cargo Cold Chain:

Advancements in pharmaceuticals are changing the face of 21st century medicine, giving patients around the world access to new life-saving drugs and vaccines. Because many of these innovative pharma and biopharma products are temperature-sensitive, the growing global pharmaceutical market is driving demand for cold chain logistics.

by: Tom Grubb
Published: March 6, 2014
Tags: global pharmaceutical market, Cold Chain Logistics

Tom Grubb

Building Cold Chain Quality with IATA’s Chapter 17:

The air cargo cold chain is like a symphony orchestra, with many performers playing in harmony as a cohesive group. Seamlessly playing as one not only demands professionals skilled in their respective instruments; it is also requires that all participants read from the same score. In the pharmaceutical cold chain, safely and effectively moving time- and temperature-sensitive products means all stakeholders need to follow the same standards, regulations and best practices.

by: Tom Grubb
Published: February 4, 2014
Tags: cold chain quality, air cargo, Tom Grubb, IATA, pharmaceutical cold chain

Tom Grubb

IMPERATIVES FOR COLD CHAIN QUALITY Part 5 – Continuous Improvement and Ongoing Enhancement:

Protecting temperature-sensitive air cargo in the cold chain is not a casual endeavor. It takes planning, training, and constant attention to time and conditions to guard the viability of delicate pharmaceuticals on their journey to the patient. This kind of proactive effort is as critical for each shipment as it is for the wider challenge of enhancing and improving the cold chain.

by: Tom Grubb
Published: December 2, 2013
Tags: cold chain quality, cold chain, continuous improvement, Tom Grubb, American Airlines Cargo, temperature-sensitive air cargo

Tom Grubb

IMPERATIVES FOR COLD CHAIN QUALITY: Part 4 - Evaluating the Results:

In the pharmaceutical cold chain, all logistics partners share the common goals of safe and successful product transportation and by consequence, patient health and safety. Planning for temperature-sensitive shipments supports effective logistics, but just as important is an ongoing review of the results. This is what allows cold chain providers to identify challenges and find ways to address them. Ensuring that life-saving medicines safely reach the end user takes coordination and continuous improvement.

by: Tom Grubb
Published: October 24, 2013
Tags: improving cold chain quality, cold chain, quality, quality management, American Airlines Cargo, Tom Grubb

Dr Nicola Spiggelkotter on Qualification

Dr. Nicola Spiggelkötter

Food meets Pharma: What are the 6 Must Haves to become a Carrier Specialized at Pharma Logistics?:

Pharma logistics has become a box-office hit, widely discussed and attracting many people, among them many carriers and service logistic providers, especially those who wants to become a carrier specialized at pharma logistics. What are the must haves to become such a specialist?

by: Dr. Nicola Spiggelkötter
Published: November 17, 2013
Tags: pharma logistics, IFS-Food logistic, food logistics, cold chain, cool chain, Good Distribution Practices, IFS Logistics, IFS logistic carrier, temperature mapping, qualification, temperature monitoring, subcontracting, deviation management

Dr. Nicola Spiggelkötter

Qualified Premises and Equipment – Focus on Trailers and Distribution Vehicles:

Qualification of large-scale active systems is becoming ever more firmly established practice, even an requirement. The revised EU-GDP Guidelines stipulate that only qualified facilities and equipment may be used. That being the case, then what would be the procedure for qualifying semi-trailers? Are there analogies to the qualification of passive thermal shipment packaging?

by: Dr. Nicola Spiggelkötter
Published: August 27, 2013
Tags: Dr. Nicola Spiggelkötter, EU-GDP Guidelines, qualification, passive thermal shipment packaging, design qualification, installation qualification, operational qualification

Carlos Castro on Cold Chain Supply

Carlos Castro

Ambient Profiles – The building blocks (Part 2):

In my last article, I mentioned that ambient profiles must be a true representation of the temperature a shipping container experiences during transit from origin to destination sites. Failure to capture realistic temperature conditions in the supply chain will create inefficiencies and increase the risk. In this second article I will describe how ambient profiles should be built and what practices should be avoided.

by: Carlos Castro
Published: May 20, 2013
Tags: Carlos Castro, temperature controlled supply, ambient profiles, ambient distribution, crt, controlled room temperature, shipping container, ambient, temperature conditions

Carlos Castro

Ambient Profiles - Deciphering the Supply Chain Elements (Part 1):

Selecting or building ambient profiles for the shipping container qualification is a difficult and intense task because an ambient profile requires a deep understanding of the distribution process and the logistics involved.

by: Carlos Castro
Published: April 14, 2013
Tags: Carlos Castro, cold chain supply, cold chain, cool chain ambient supply chain, ambient profiles, ambient, shipping container qualification, ambient temperature

Carlos Castro

Cold Chain Industry Forecast for 2013:

I’d like to share with you some of the key points I gathered this year and my predictions for cold chain in 2013.

by: Carlos Castro
Published: December 23, 2012
Tags: cold chain 2013, 2013 industry forecast, Carlos Castro, emerging markets, freight forwarders, Regulations, standards, collaboration, training, logistics, predictions 2013

Carlos Castro

Chilling out in Brazil - Post Show Report:

I was very impressed about the quality of the event because the speakers, the topics that were presented as well as the audience itself was very diverse and offered something for everyone. Among the topics discussed were local regulations, validation, distribution (import to Brazil, domestic and last mile), security, ambient profiles, logistics optimization, etc.

by: Carlos Castro
Published: October 24, 2012
Tags: Brazil, Carlos Castro, World Cup, Olympic Games, 6thPharma Logistics and Cold Chain Conference, Brazil cold chain, Brazil biopharma market, security, ambient profiles, logistics optimization, Brazil logistics market, validation, distribution, local regulations, imports

Laurent Foetisch

Laurent Foetisch

New GDP Guidelines Spell Substantial and Drastic Change for the Entire Pharma Industry:

As per the GDP the main change will be related to ambient (15° to 25°C) shipment which will impact all the entire temperature controlled transportation and qualification processes.

by: Laurent Foetisch
Published: April 4, 2013
Tags: GDP guidelines, GDP, Laurent Foetisch

Richard Ellinger

Richard Ellinger

A Muted Outlook in 2013:

Every one of us in the temperature assurance market would like to know if this will be a strong year for our collective businesses or not. It is very difficult to tell these days considering the ‘fiscal cliff’ discussions produced by our daily media outlets.

by: Richard Ellinger
Published: January 22, 2013
Tags: 2013 outlook, 2013, Richard Ellinger, temperature assurance market, fiscal cliff

Richard Ellinger

Review of New Products Launched in 2012 for Cold Chain Packaging:

As 2012 comes to an end, we take a look at the Cold Chain packaging companies that launched new products in 2012. We collected data sent to us by manufacturers and combined it with our own research of publications and press releases throughout 2012.

by: Richard Ellinger
Published: December 19, 2012
Tags: Richard Ellinger, packaging, Cold Chain Packaging, TAG, pharma packaging, 2012 review, Acu-Temp/C-Safe, Cold Chain Technologies, CryoPak, DS Smith Plastics/Cool-Logistics, Intelsius, Pelican, Minnesota Thermal Science, Laminar Medica, Sonoco/ThermoSafe

Richard Ellinger

Cold Chain Market Trends for Suppliers:

Trends. In everyday life, people talk about trends but sometimes they are difficult to see if you are too close to the action. In business, strategic minds try to decipher market trends to assess the appropriate direction of their customers & competitors and therefore the next steps their own company should take to be ahead of the actions that result from the trend.

by: Richard Ellinger
Published: October 23, 2012
Tags: cold chain trends, cold chain logistics trends, cold chain market trends, Richard Ellinger, Temperature Assurance Group, logistics services, data monitoring, packaging, warehousing services

Richard Ellinger

NIH Funded Silk Study Questions:

In July the NIH News published research that states: "Researchers funded by the National Institutes of Health have developed a new silk-based stabilizer that, in the laboratory, kept some vaccines and antibiotics stable up to temperatures of 140 degrees Fahrenheit." In order to better understand the implications to the cold chain market of these findings, I sought out Dr. David Kaplan, Tufts University, and asked him a few questions that came to my mind as I read the NIH News research.

by: Richard Ellinger
Published: August 14, 2012
Tags: Richard Ellinger, NIH Funded Silk Study, Dr. David Kaplan, U.S. Department of Health and Human Services NIH News, National Institutes of Health, silk-based stabilizer, non-lyophilized vaccines, implications to cold chain market, lyophilized vaccines, silk, silk protein

Quality in the Cold Chain

Humberto Laserna

Importance of Cold Chain in Latin America:

To assure the cold chain, we should have robust processes, suitable qualifications, effective training programs, risk assessments and back-up plans, challenged periodically.

by: Humberto Laserna
Published: August 19, 2012
Tags: cold chain Latin America, Humberto Laserna, quality management, risk assessments, Brazil, Mexico, cold chain assurance, GDP

Energize The Chain

Dr. Harvey Rubin & Alice Conant

Rerouting Power. Reshaping Health:

Rapid progress was made in implementing this innovative cold chain strategy after Energize the Chain presented its strategy to a receptive audience of cell tower operators and suppliers at the GSMA Green Power for Mobile Conference in Mombasa, Kenya in March 2011. We developed a very close working relationship with Econet Wireless, the major cell tower operator in Zimbabwe.

by: Dr. Harvey Rubin & Alice Conant
Published: August 14, 2012
Tags: Dr. Harvey Rubin, Alice Conant, Energize the Chain, Bill and Melinda Gates, Decade of Vaccines, life saving immunizations, EtC, cell phones, Energize the Chain model, cold chain, immunization program, UNICEF, cell tower technology