This time of year, we always reflect on one of the most important tasks for any organization—being prepared for the unexpected. It is important to have a contingency plan at every point in the pharmaceutical supply chain — for every organization that has a role in that supply chain. That goes not only for the drug companies themselves, but for logistics suppliers like Singota. One crucial benefit a company gets from its contractors is backup capacity in case of emergencies. Even as a contractor, we have a reciprocal partnership with another organization that can provide backup storage in the event of an emergency affecting our facilities. We are their backup, and they are ours.
We must prioritize having these arrangements in place. Contingency planning nearly always comes up during the many audits that CDMOs go through. We literally could not operate without a business continuity plan, including both contingency storage and backup power generation. And this is just as important for the pharmaceutical companies we serve.
Like insurance, contingency planning includes assets you may never use; in fact, you hope you never have to use them. But you go through all the formalities anyway, including audits of both their facilities and procedures in route to approving them as a qualified partner.
Consider how drug companies have stability studies to realize and document how long their products can be stored out of the approved temperature range without affecting their therapeutic properties. Assuming the company is sharing that information with its contingency storage partner, those stability studies establish the practical limits and emergency planning, such as how far away that partner could be located.
As a drug company will often contract for contingency storage, in some cases this may include dedicated refrigeration space where no other firm’s material can be stored. Those coolers or freezers are reserved, whether there is any material in them or not. The company’s calculation is that it’s worth it to know that the real estate is available at their disposal if they ever need it, which also means they satisfy the requirements of their own internal audits.
Of course, it isn’t only refrigeration failures that lead to emergencies. Emergencies can arise in any part of the country. Facilities in coastal cities are vulnerable to hurricanes. In the Midwest, there are tornadoes. Other parts see devastating fires, frigid cold temperatures, record amounts of snowfalls, etc.
Redundancy is standard in the pharmaceutical industry, whether it be redundant supply (ordering of a key material in the manufacturing process from several different vendors), redundant environmental controls, or redundant storage capacity. It’s critical for business continuity, and it is worthwhile for the pharmaceutical company to ensure that its contractors take it as seriously as they do.
Business continuity planning is built into Singota’s Supply Chain Services. Visit our SCM page for more information.