Holding The Supply Chain Accountable

By Jeff Clark, 7P Solutions™, LLC

Quality is certainly not new terminology in the pharmaceutical industry. However, I believe it is a term that is sometimes used too loosely within the pharmaceutical time and temperature supply chain. Please don’t get me wrong, there are numerous conferences throughout the year that are very good and focus on best practices, temperature monitoring, security, and everything new in the time and temperature supply chain. There are also many pharmaceutical companies who spend a great deal of money validating their shipping lanes, packaging solutions, and monitoring devices. These are all important initiatives that should be done. The findings of these tests and validations, or the protocols developed, should be used properly throughout all stakeholders of the supply chain.  But this, more times than not,  is often overlooked — or doesn’t occur at all — as a matter of convenience  for all parties involved.

Supply Chain Quality Is Better, But There’s Still A Long Road Ahead

During the early 1980’s and through the ‘90’s I was fully involved in the management and handling of pharmaceutical shipments globally for several major pharmaceutical companies and security and environmental monitoring certainly were not a primary topic of discussion.   In late 2003, I entered the biorepository business where we provided storage, inventory management, and logistics on behalf of the life science industry. During that time, I learned firsthand how important protecting product integrity was, as well as the value of the products we were entrusted with. I also realized it was more involved than just moving a shipment from point A to point B; it was also the real sensitivity of the majority of the products within the life sciences supply chain.  We were audited by every client who did business with us and, in many cases, before they would ever consider doing business with us. These were extensive audits that included the facilities, IT, training, and our transportation procedures for both inbound and outbound shipments.  What was interesting to me was during all my years  prior to this in transportation not once had I been audited by any life science client.

As the pharmaceutical supply chain matured over the years companies and regulators began to better understand the importance of understanding environmental effects on products as they moved throughout the supply chain and began taking closer looks at better controls, temperature monitoring and other products to help protect the quality of the product during transport.

The more I have worked within the climate controlled supply chain in the past few years, I have noticed that the pharmaceutical industry is becoming much better at conveying their requirements to service providers, in order to maintain product integrity and secure the product.  In fact, I have recently seen many pharmaceutical requirements and standards for service providers become very detailed in scope — relating to both environmental monitoring and security.  The downside is that these protocols are rarely understood down through the ranks of the operations of the service provider and those to which they outsource critical steps. On some occasions, if it were easier or less expensive to overlook the protocol, it was not unusual to see it overlooked.  Mind you, these were not things that were done maliciously, in fact most were very innocent (to the offender). All were done because of lack of knowledge and training.    Unfortunately, some were things which people/companies falsely claim they do, or they do not follow through with the requirements.

Overcoming Quality Deficits With Accountability And Education

As the regulations around the world require more accountability, we hear some arguments against Good Distribution Practices (GDP) and how implementation of them will increase climate controlled supply chain cost.  I‘ve even read concerns that this would increase the cost of training of staff. This raises a question in my mind: how does GDP regulation increase cost? Anyone involved in the climate controlled supply chain should have been practicing these protocols anyway. Now you will just be held accountable to prove that you have performed and managed the product in the manner in which it was to be managed. Regulations such as replacement of the vague “ambient” temperature with controlled room temperature (CRT) will certainly help with clarity and expectations of those transporting and storing these time- and temperature-sensitive products, which is where I focus my efforts. 

Pharmaceutical companies must educate themselves as to who in the supply chain is handling their product, has the ability to protect the integrity of the product, and ensures the security of their investment.  A traditional 3PL may be outsourcing the entire move to several different players, none of whom have been properly vetted, and those that they are outsourcing to may be also outsourcing.  We read about “fraudulent pick-ups”, which with proper controls and management should never occur. These incidents are the perfect examples of too many hands involved where the bottom line is all about the price, rather than using the proper partners who will do it correctly.

There are many questions that should be asked of the service providers within the climate controlled supply chain. It is a specialized area that deserves the proper attention to protect the integrity of the product, the investment of the client, and the client’s brand in the marketplace. A mishap could ruin the brand of the product or that of the entire organization. So, the same questions and processes should be implemented when establishing a service provider, as you would a contract manufacturer. 

• If you are a global company, do they have a global reach or is your model going to regionalize your supply chain?  Can they implement or participate in a global quality management system (QMS)?
• Who are their vendors and how are they vetted? What is the frequency of vetting/auditing?  As an example: if you are using ABC Freight forwarding in the U.S. for your inbound airfreight shipments, do you know the trucking companies that they utilize to transfer your cargo at the airport or to make the deliveries to your facilities or distribution centers?
• Who does your customs clearance?  Do they merely understand customs regulations and tariff numbers or do they know your product and the difference between dry ice and wet ice?
• How close are you to the trucking companies that your 3PL or freight forwarder is using? In most cases, they have your product in their possession more than any company involved in the transaction. Do they outsource if they do not have the capacity to move your product? How do they monitor environmental conditions and security?  Driver training?
• What type of QMS do these companies have in place? More importantly, do they use it, and has anyone ever audited them? 
• What type of training is focused on time-temperature sensitive products? Is it effective to the desk level or smoke and mirrors? 

When pharmaceutical companies are looking at their climate controlled supply chain, they should include staff from the quality assurance, security, and logistics departments, who together create a comprehensive global quality management program that is to be implemented amongst all service providers. This must be a living document and all stakeholders must be held accountable.  

Understanding that the FDA does not have the resources to carry out inspections and audits within this arena, we must partner with pharma to police the industry ourselves.  The first step in this process is to practice what you preach, follow through, and hold those responsible in the chain accountable for their actions. 

With the rise in smaller specialized cGMP-GDP focused service providers, I see the industry rising to a different level and the expertise, experience, and reliability becoming something tangible. It’s not enough to have a group sitting in an office calling itself the “cold chain” or “control tower”.  The expertise must be driven throughout everyone within the operations who is touching the transaction.  Keeping the focus of patient safety is instrumental to the success of the entire time- and temperature-sensitive supply chain and should be the focal point of every training program.

About The Author:
Jeff Clark is the Founder and President of 7PSolutions, LLC, a company focused on implementing quality management systems across the pharmaceutical climate-controlled supply chain, as well as providing the latest in GPS-GSM environmental and security monitoring and management technologies to the pharma and logistics industry. With an IATA/FIATA Cargo Agent certification in 1982, Jeff has a very unique background that combines global transportation with the pharmaceutical and biotech industries.