“Leaders win through logistics. Vision, sure. Strategy, yes. But when you go to war, you need to have both toilet paper and bullets at the right place at the right time. In other words, you must win through superior logistics.” (Tom Peters – Rule #3: Leadership Is Confusing As Hell, Fast Company, March 2001), from Famous Logistics Quotes (here)
Quality Risk Management (QRM) as specified in ICH Q9 often finds its boundary at the batch release decision. However, the product has no public health impact when it is sitting in a warehouse. Your product is transported by third-party shippers and couriers who frequently operate across a multitude of industries, commodities, modes, and conditions. When product leaves a site for distribution, it could be argued that the need for a proper risk assessment is even more important, since the product may not be in the company’s control after leaving the local site’s shipping dock. Upon arrival at the destination, the risk inherent to GMP decision making is now assumed by the receiver.
Decisions are made based on data. As a result, the receiver of the product can only be as confident in their decision as the integrity of the data used. The “Completeness” (as stated in ALCOA+) of the record may not be in a singular system. This dilemma is discussed in part in a blog with a unique perspective by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) (here). This blog is a great integration of the concepts of both Data Integrity and QRM. Even though DI and QRM have merged in focus and urgency relatively recently, the regulations themselves for Good Distribution Practices (the GDP of GxP) have been in both the FDA CFR’s (211.180, 211.142, 211.42) and EU’s “Guidelines on Good Distribution Practice of medicinal products for human use” (here) for many years, and are by no means new or novel. Additionally, the EU guidelines specifically address the use of outsourced services, which is an inevitability for global companies.
The commercial and regulatory case for including distribution when performing data mapping exercises has been demonstrated starkly with the weaknesses in the supply chain revealed by the Covid-19 pandemic. The industry and governments are actively looking to define signals to predict potential supply chain disruptions as investigated and reported in the US FDA Report, “Drug Shortages: Root Causes and Potential Solutions” (here). In the scope of the bigger mission on getting needed medications to patients worldwide, Good Distribution Practices, DI, and QRM need to work as interdependent thought processes.
If you need any assistance in data mapping or performing a risk assessment across your entire supply chain (including your distribution partners), please reach out to us for an assessment at P.Day@LachmanConsultants.com.