Meeting the challenges of supply chain regulations

NGP speaks to two experts about the changes affecting the pharmaceutical cold chain. With Jean Bédard, Alternatives Technologie Pharma Inc. and Richard Harrop of SCA Cool Logistics

“The interest in creating more robust and effective cold chain solutions has grown dramatically”
-Richard Harrop, SCA Cool Logistics

NGP. The pharmaceutical industry is subject to increasingly stringent regulations regarding its supply chain. What challenges does this present to companies?
Jean Bédard. Companies involved throughout the pharmaceutical supply chain must comply with the new stringent regulations on the storage and transportation of pharmaceutical or medicinal products.

One challenge is to gather all the necessary data and information to have a clear understanding and knowledge of the storage and transport conditions that prevail throughout the supply chain. This can be a long and complex process as it involves uncontrolled environments (transports, seasons) and many potential stakeholders, such as wholesalers, transporters, pharmacies, etc. While pharmaceutical warehousing and storage zones are controlled environments easier to validate, uncontrolled environments such as those observed during the transportation and distribution of drug products (ground, sea and air) certainly represent a challenge to companies.

Another challenge is to reach a pharmaceutical supply chain that is both fully compliant and economically sound. An optimal pharmaceutical cold chain should ultimately provide compliance but limit the additional distribution costs.

Richard Harrop. I am often tasked with evaluating the impact of new regulations and industry guidelines on a company. When doing this it is vital to understand the key focus areas; performance and price. Do new regulations demand greater performance and will this greater performance increase cost?

NGP. What methods can companies use to comply with these regulations?
RH. Partnership is key. The pharmaceutical manufacturer, logistics provider, ancillary packaging designer and data-logging supplier should be discussing the project together from day one. Building this team ensures clarity is present throughout the development process and all aspects of the supply chain can be considered

JB. There exist various methods to be used in order to reach cold chain compliance. Our approach is to start first with an exhaustive cold chain regulatory gap analysis where the pertinence of the cold chain regulations, as well as the extent of cold chain management actions to be applied are verified and established in regard to the audited company and supply chain.

This preliminary step enables us to develop a cold chain compliance plan that can be orderly and progressively implemented to the company and its supply chain.

The compliance with cold chain regulations will require acting on various cold chain quality aspects, from optimizing stability and temperature excursions test studies, updating the cold chain quality system (personnel training, procedures, quality agreement), validating all cold chain processes and equipments (mapping of warehouses and storage areas, temperature profiles study during transport, I/O qualification of temperature-controlled storage systems), up to installing cold chain monitoring where needed (temperature-controlled storage and transportation areas, shipments and products).

NGP. What tools are available to enable companies to maintain the integrity of their products during the manufacturing and supply chain process?
JB. Cold chain monitoring and packaging systems are certainly the major tools to maintain the integrity of products during the manufacturing and supply chain process.
We now have efficient and user-friendly monitoring systems to automatically and continuously monitor the environmental conditions during the handling, storage and transportation of pharmaceutical products. Companies have access to new technologies such as monitoring solutions, wired/wireless sensor networks, data loggers and thermocouples to effectively monitor manufacturing facilities, warehouses and storage areas, storage equipments, transports, shipments and products in transit. Furthermore, a special attention should be put on new RFID sensing technologies that enable to track and trace cold chain, products and shipments.

As for monitoring, shipping and packaging technologies are evolving to offer better thermal protection and performances and to conform to your logistic needs. New conditioning and insulating materials (VIP, polyurethane, Phase Change Materials etc) are introduced while reusable temperature-controlled containers are proposed for international shipments. Another important tool to be developed resides in temperature-controlled transportation modes (e.g. temperature-controlled ground trailers).

RH. Over recent years the interest in creating more robust and effective cold chain solutions has grown dramatically. Even without the pressure of regulations, companies seem to have even greater desire to ensure product integrity. However we still come back to the debate of performance versus cost.

At SCA Cool Logistics we have dedicated resource to exploring the possibilities of new cold chain solutions and by working closely with all our industry partners we have been able to develop solutions that meet both performance and cost requirements.

Today our pharmaceutical partners can select solutions that
  •  Come ready qualified against real-world temperature data
  •  Offer controlled cooling and heating without batteries or preconditioning
  •  Hold loads from one litre up to 800 litres and beyond
  •  Last for a single shipment or can be reused
  •  Can be returned to us for cleaning
  •  Can reach durations exceeding 120 hours, regardless of ambient conditions
  •  Are thermostatically controlled

NGP. How do you see the pharmaceutical supply chain developing in the future?
RH. Green solutions that fulfil a company’s corporate social responsibility whilst addressing the need for maximising cost effectiveness – these are the systems of tomorrow. Environmental accountability is already bringing considerations regarding recyclability, carbon emissions and energy cost. Cold chain is one part that can be re-evaluated from a green standpoint.

Green solutions already exist, but what must be considered is how they are implemented. The green credentials of a solution must be measured alongside how that solution is used. Will components need to be conditioned within refrigerators or freezers? Are suitable facilities available to breakdown the biodegradable container? How many miles does the reusable system need to travel before it returns to its point of origin?

If we look at two different products, ZeoCool and GREENBOX, we can see that both have the possibility to solve to green issues, but in very different ways.

The ZeoCool system uses the process of evaporative cooling which removes the requirement to pre-condition components; this is an environmental benefit considering that Europe's refrigerators and freezers account for 62 million tonnes of carbon-dioxide emissions every year.

ZeoCool offers:
  •  Reduced total system payload, which in turn reduces the transport or fuel consideration.
  •  Simpler packing process, which means reductions in occupied packing space and man-hours.
  •  No requirement for costly and energy-hungry refrigerated transport

GREENBOX is a completely sustainable thermal packaging system, created with 100% recyclable, organic-based, non-toxic and some fully biodegradable components.
  •  Reusable shipper: The resilient nature of GREENBOX means customers can use one box up to 50 times. Reclamation centres gather used GREENBOXes, inspect, clean and re-certify them for re-use.
  •  Sustainability: GREENBOX’s innovative materials are 100% recyclable.  When the hard plastic outer and Thermal-Lok insulating panels reach the end of their lives they are ground down and made into new shells and panels. In addition, GREENBOX features biodegradable, non-petroleum, non-toxic phase change materials.
  •  Reduction in distribution-related expenses: Customers can save up to 65 percent on distribution-related expenses due to GREENBOX’s unique, reusable design.
  •  Any-day shipping: Because GREENBOX maintains temperature for up to five days; customers can ship road freight – even on Fridays –resulting in up to 65 percent reduction in shipping and distribution costs. 

JB. As for the drug development side with GLPs, the manufacturing side with its GMPs, and the clinical trial side with the GCPs, the pharmaceutical supply chain side is going to be significantly impacted with good storage and distribution practices (GSDPs) to ensure the highest levels of security and safety for the drug products going throughout the supply chain, from the manufacturing facilities handoff up to the final end-users (patients).

Cold chain compliance and anti-counterfeiting are certainly the two major pillars in making the supply chain more secure and safe. As a consequence, a great regulatory emphasis will be put on these two aspects, thus leading to more generalized good storage and distribution practices (GSDPs) in the pharmaceutical supply chain.

In a nearby future, we will probably see a more specialized pharmaceutical supply chain, meaning a supply chain where stakeholders such as wholesalers or transporters will be more focused on providing services and quality that fulfils the new pharmaceutical supply chain requirements.

Jean Bédard MBA is Chief Executive Officer of Alternatives Technologie Pharma Inc.
He has lead Alternatives Technologie Pharma Inc. and its impressive team of cold chain and track & trace management experts since 2003, and has managed more than 100 cold chain compliance programs in the Life Sciences and Healthcare sectors. He holds a MBA in Bio-industry Management.

Richard Harrop is the Commercial and Technical Manager of SCA Cool Logistics and has been involved in the temperature control packaging industry for six years, initially in packaging design and then also moving into the commercial field. 

Qualified in structural packaging design, Richard previously worked as a technical designer for the FMCG sector before moving into the world of temperature control packaging where he has worked predominately within packaging technology.

Richard has developed and implemented several successful temperature control solutions for many of the worlds leading pharmaceutical corporations.