First? It depends on your definition of first.

A few weeks ago, while participating in the 2019 Cold Chain Global Forum, I reflected on how and why 7PSolutions was created. Moreover, I thought back to April 2010, when we first launched 7PSolutions and realized how much the industry has changed since then.

My 27-year experience in global transportation, as well as my 7-year experience with the creation of unique solutions for the management and storage of clinical trial patient samples, drugs, and human donor tissues exposed me to gaps in the management of pharma supply chains. This was first brought to my attention when the same customers utilizing BioStorage’s ultra-cold storage were required to do quality audits before doing business with us. Shockingly, those same customers were not auditing us when I was moving their product around the world. The second situation occurred while I was designing packaging for a large clinical trial where the patient samples were to be stored at 2 to 8°C and transported at ambient. My first question to the customer was “what is ambient?” Albuquerque and Minneapolis have completely different ambient conditions in the wintertime – silence.

From the end of 2002 through Q1 2003 we had written a robust quality management system to manage the thousands of irreplaceable samples which we were moving daily. In 2010, when 7P was founded, we enhanced these SOPs which could then be implemented into any transportation service provider globally. With that QMS we combined real-time GPS technologies, most of which were gained from a specialized trailer that I had designed having the ability to manage five (5) temperatures, redundancies with two (2) generators, three (3) refrigeration units, 13 cameras, all spare parts carried on board and more.

Our naivety led us to create an innovative service as well as new technology which we believed to be the norm. However, our findings were surprising and quite the opposite. Since our beginning, our approach has been validated as a few have attempted to duplicate our services. 

Because of our background and experiences in 2010 we brought to the industry a new look at how GPS services could be utilized. Still today we continue to build upon those services and technologies with devices being used in all modes of transportation, built into intelligent shipping containers and used for everything from porch piracy to inventory management. 

It has always been our belief and goal to offer the global supply chain the best customer service, solutions, and hardware, being first was not something we are too concerned about. However by default and our naivety we raised the bar, until 7PSolutions:

1.    There was no complete supply chain management GPS platform 

2.    There was no GMP designed, developed and tested GPS platform 

3.    There was no GPS software providing intelligent data 

4.    There was no ability to attach documents from driver interviews

5.    There was no ability to send documents and real-time tracking to the “first responder” live

6.    There was no Disposable real-time GPS device

7.    There was no GPS software incorporating EDI 

At the end of the day, I wondered how far have we came and what has changed. The article below was written by me in January 2013 almost seven years ago during a series of articles that Pharmaceutical Online asked me to do to raise awareness to stakeholders of the pharma supply chain. 

Still today the regulations are ever-changing, the technologies are changing and your requirements are changing. Are you asking the right questions?

How To Bridge The Quality Gap In Your Climate Controlled Supply Chain

Over the last several years, organizations such as the World Health Organization (WHO), Parenteral Drug Association (PDA), and International Air Transport Association (IATA) along with most countries’ Ministries of Health or similar agencies have written guidance and regulatory documents regarding the handling and management of time and temperature-sensitive healthcare products during transport and in-transit storage. These documents are all very similar in scope, but they do have their differences. In response, pharmaceutical companies have been spending millions of dollars testing and validating shipping lanes, packaging solutions, and monitoring devices. That is in addition to the investments into education — such as attending cold chain and security conferences and hiring consultants to review, study, and counsel on data collected, routes utilized, preferred packing methods, and best practices.

All of these things are valuable and play a very important role in the development and implementation of best practices and processes within each pharma company’s supply chain. One must understand not only the stability of their products, but also the proper packaging solution for each mode of transport, and who are the viable solutions and service providers that have the expertise to maintain product integrity and security. However, as the pharma industry is testing and developing a greater number of products that will require even more specialized management and handling than in the past, it is important for all the players — including trucking companies, couriers, packages, and other service providers — to understand the requirements to implement and sustain a quality supply chain. The requirements of controlled room temperature (CRT), humidity, light exposure, vibration, and worries of bioburdens and security must be considered and met throughout the entire climate-controlled supply chain — and all parties involved must be held accountable.

Getting On the Same Page Of Quality

One thing I’ve learned is despite all of the investments mentioned above, there is still a large gap in the knowledge or training of those providing the day-to-day operations and the monitoring or enforcement of any quality management system (if there is a quality management system in place at all). To make sure all stakeholders in the climate-controlled supply chain gain a unified understanding of your quality goals, there are several important questions you must answer.

1.    What is the value of the information that is being learned from internal studies and how is it utilized throughout the supply chain?

2.    Is the information we are gaining from conferences and other educational sources being shared and used properly? Is this information useful, or are we receiving the same information time after time, only to be presented differently? (This can be accomplished by starting internal training, as well as implementing SOPs and best practices as guidelines.)

3.    Is this information current, and are we challenging ourselves? More importantly, are we practicing what we preach?

4.    Are we utilizing this information to meet regulatory body requirements, with the ultimate goal of patient safety?

As with any QMS study or training program, the information being gained must be shared and driven up and down throughout all stakeholders of the supply chain. This includes all outside vendors who are intimately involved in the handling of a product daily. This can only be accomplished by implementing comprehensive QMS programs which are all-inclusive and followed up with the proper training programs, and annual internal and external auditing programs.

Using cGMPs As Your Guide To Quality

Without an educated and compliant climate-controlled supply chain, the pharmaceutical industry operates at a high level of risk. These risks will elevate as regulatory agencies require documented proof of how temperature-sensitive product was handled during transport and in-transit storage. As more sensitive products, such as cell-based medicines are developed, the need for documented evidence of environmental conditions will be a necessity, not just something that’s “nice-to-have”. The pharmaceutical supply chain is in the midst of change, bringing more products into the mix which will require product integrity protection, high values requiring more security, and global scope — all requiring accountability of all stakeholders.

As current Good Manufacturing Practices (cGMP) – Good Distribution Practices (GDP) become regulation around the world, the pharma industry must challenge itself and look at the standards they hold their contract manufacturers to, and ask “why would we not hold our climate-controlled supply chain to those same high standards”?

These principles must be the focused topic of discussion with all involved in the climate-controlled supply chain. And, although quality has been a topic of discussion for some time, accountability must be also in place.

Within cGMP, the following general requirements exist:

1.    Quality is the responsibility of all persons involved.

2.    Quality Assurance/Quality Control is a separate unit that is independent of operations, sales, and management.

3.    Quality Assurance performs regular documented internal audits.

4.    There should be an adequate number of personnel qualified by appropriate education, training, and/or experience to perform and supervise under their job description.

5.    The responsibilities of all personnel engaged in the performance of the duties performed should be specified in writing.

6.    Training should be regularly conducted by qualified individuals and should cover, at a minimum, the particular operations that the employee performs and GxP as it relates to the employee’s functions. Records of training should be maintained and periodically assessed.

7.    Consultants should have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained.

These points represent a small sample of the regulatory requirements for which service providers within the supply chain have accountability.

The majority of excursions, problems, and delays I have witnessed (except for weather and mechanical issues) were due to one simple problem: cGMP was not being followed (or in place) — whether it was training, experience, knowledge, or adequate staff. And never once did I see the parties involved issue a Corrective Action | Preventative Action (CAPA).

Today’s pharma climate-controlled supply chain requires one quality management system across all modes of transportation that allows for adjustments for country-specific requirements — while still holding all parties within the supply chain accountable. Contract manufacturers are held to very high standards to ensure the quality and efficacy of your drug products, why jeopardize your investments to a supply chain absent of the same?

Maintaining product integrity and keeping your product secure throughout the supply chain can seem like a monumental task and some areas of the world do have their challenges. By using transportation-minded people, lead logistics providers can orchestrate your climate-controlled supply chain door-to-door while understanding the importance of cGMP – GDP. This will ensure you have the proper visibility and proof you need to validate your products were handled appropriately, ensuring patient safety.

About The Author:

 Jeff Clark is the Founder and CEO of 7PSolutions, a company focused on implementing quality management systems across the pharmaceutical climate-controlled supply chain, as well as providing the latest in real-time GPS environmental and security monitoring and management technologies to the pharma and logistics industry.