September 22 - 25, 2020 | Sheraton Boston, MA

Change & Collaboration PART II: Process Standardization & Documentation

By: Elizabeth Mixson
07/03/2019

Check out Part I of our Change Management series here.

Fully standardized packaging vendor qualification requirements 

When comparing models, many firms struggle to determine which packages they should invest in to transport their medicines; due to the lack of standardization in the qualification testing conducted by manufacturers.

The existing guidance on qualification testing is helpful, but the number of different thermal profiles and testing procedures used in the market (regarding product loads, preconditioning requirements, etc.), can create confusion when trying to directly compare containers.

Selecting the wrong container would be a significant waste of investment and risk the safety of high-value drugs as they travel through challenging climates. Fully standardized packaging vendor qualification requirements would allow for quicker and more informed selection of packaging for drug manufacturers. Costs would be lowered as there would be less of a requirement for additional internal testing when buying an off-the-shelf solution.

Tests could instead be run purely to simulate performance in worst-case scenarios or if a specific use case was tested to reduce the cost or weight of the package. This change towards standardization would hinge on collaboration because if only a few suppliers move adhere to the requirements, manufacturers still can’t draw direct comparisons across the whole market. Craig Vermeyen notes that it could take some time for the industry at large to convert.

This change is likely to have significant growing pains as it benefits end users the most, but asks the most change from the vendors. End users have limited control in sparking the change.

It’s mainly the suppliers who are going to need to find a way to collaborate. Craig Vermeyen said “[Vendors will have to] work with their competitors which is definitely a unique challenge that won’t be easy to achieve. But we need to find some way for them to all agree on how to align with each other to find the best way to test in a standardized method that is easy for customers to understand.”

Craig Vermeyen notes that users may need to collaborate to financially motivate suppliers to change how they are qualifying products and provide guidance on where the demand lies on the temperatures to test to, payload configurations etc.

He said: “If we are able to unite and say: ‘We are more interested in buying solutions from vendors who have been able to change the way they present the data to make it easier for us.’ This may act as an incentive for suppliers to change the way they are qualifying containers.”


Entering a new emerging market

The daunting cultural learning curve involved with entering an emerging market is made achievable by collaborating with a trustworthy local expert. When selecting such a partner, shippers should consider whether their network is sufficient to meet market requirements. The partner should have a good reputation with local customs, health authorities and ground handling agents for sensitive items.

Guy Hoskens, Clinical Supply Chain Logistics Expert within Janssen, Pharmaceutical Companies of Johnson & Johnson warns: “It’s important that the logistics considerations and teams are involved early enough in the process when setting up a new region. If that is not happening early enough, then logistics executors will be confronted with challenges in set-up. Pharma firms should have good local contacts in place who can help them with understanding the local requirements that are set up as quickly and as efficiently as possible.”


Change of transport mode in a lane

Tarmac exposure time is a phrase that can instill fear into many pharma logistics professionals. Many perceive this as one of the biggest challenges when transporting medicines via airfreight. Many in the industry have opted for sea freight over air-freight to transport medicines as it is cheaper and involves less touch points. The Seabury Group maintains that every year 0.5 million tonnes of pharmaceutical products are transported by air, compared to 3.5 million tonnes by sea.

Even though airfreight sees a lower volume of pharma traffic , the overall value of the pharma cargo moved is much higher than sea freight. David Bang, Global Head of DHL Temperature Management Solutions clarifies that when a swift supply is needed for medicines - airfreight comes into its own.

Also, although some flaws remain in transporting Controlled Room Temperature (CRT) drugs via air-freight, providers in the space are taking strides to make the air more viable for medical cargo.

When gearing up to collaborate with airfreight partners, Guy Hoskens notes: From an airport point of view the pharma side of the business is often only a small piece. It’s a high value and high-end market, but indeed understanding the niche needs is not usually a critical concern. Airports mostly work with industries where the big volumes are situated and that’s not typically pharma.

“So make sure the providers in your chain have a good understanding of your requirements and apply the necessary measures to handle your product. For instance, ensure they understand the importance of making sure that your product is not left out on the tarmac for too long and stored temperature controlled as long and much as possible before and after the flight.”


Safeguarding change – Lost in translation effect

When initiating a change pharma firms need to beware they do not suffer from the lost in translation effect. Processes need to be documented correctly when changes are made to accurately represent what occurred. Big pharma firms are likely to have the processes in place to prevent the lost in translation effect occurring. Biotechs or smaller pharma entities are more at risk of the lost in translation effect. By preventing the lost in translation effect, firms are able to conduct various transfers or changes and avoid issues when validation is needed. For example, when a lab wishes to relocate internationally, the validation of the lab transfer will be greatly simplified and the risk of wasting time and money will be minimized, if the unit had a well-documented process.

Tonino Antonetti, Executive Director, Regulatory Affairs, Quality Management, Safety & Health at Roche Diagnostics believes the industry would greatly benefit from a standard on this matter, a guideline or whitepaper, which outlines expectations and best practices to maximize chances for success. 


Want to learn more about managing change in pharma logistics? Join us in Boston this October 15 - 18  for the 2019 Cold Chain conference!