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The crux of an effective pharma recall

December 2, 2019 by MasterControl

Pharma can take steps now to prepare for the interconnected, digital supply chain

By Matt Lowe, President of Labs, MasterControl
Dec 02, 2019

Anytime the government moves faster than you, there’s a problem. In this case, pharmaceutical companies that hesitate to digitize may be surprised to learn that multiple regulatory agencies have digitized ahead of them. For example, the U.S. Food and Drug Administration (FDA) has not only gone digital with its internal document control, it has continually embraced new ways to use technology to ensure the safety of the products it regulates. A perfect example of this is the U.S. Drug Supply Chain Security Act (DSCSA), which aims to increase traceability throughout the supply chain.

DSCSA outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs. The legislation went into effect in 2013, but pilot projects to explore useful technologies only started this past February. The FDA has made it clear that they are open to pretty much anything and everything that supports enhanced product tracing and verification. Keeping that in mind, there are steps pharmaceutical manufacturers can take now to begin preparing for the interconnected, digital supply chain.

Where we are

The first step is admitting you have a problem. And most pharmaceutical manufacturers have the same problem — paper. Paper-based processes are imprecise, slow and cumbersome. A hybrid system that includes some digital elements, such as Excel, isn’t any better. These methods still require manual data input, limit accessibility and hinder communication. This creates a scenario in which problems are likely to slip through the cracks and, when they are detected, the ensuing recall process is as slow as any other paper-based process.

When it comes to manufacturing, many pharmaceutical companies are still printing out standard operating procedures (SOPs), signing off on training using physical documents, and populating their batch records by hand. Manually inputting data introduces human error which slows down the manufacturing and recall processes, ultimately costing time and resources. Manual data entry is also imprecise, which leads to pharmaceutical companies pulling more lots from shelves than were likely affected. While it’s better to pull more product than not enough, this still represents unnecessary waste that could be avoided with a better system.

Digitizing with manufacturing software, such as an MOM, MRP, MES, etc., can help with some of these problems, but still leaves much to be desired. A perfect example of this is batch records. Pharmaceutical companies that implement electronic batch records (EBRs) are looking to automate their processes and reduce the problems caused by human error. Unfortunately, with rare exception, EBRs usually over promise and under deliver, so even companies that have digitized end up with batch records that are difficult to review and disconnected from the operator, leaving out critical elements in understanding what happened in the manufacturing process.

Why are we still here?

Pharmaceutical companies, along with other highly regulated companies, suffer from being overly cautious. This isn’t always a bad thing — the drug approval process exists for a reason. However, when it comes to technology, pharmaceutical companies would do well to move a little faster. Compliance is a concern and it should be a factor when considering digitization. Keeping that in mind, there are still many solutions that would expedite pharmaceutical manufacturing processes while maintaining compliance. With proper research, companies can make this move without worry.

Another point to consider is a problem that plagues every industry — an aversion to change. “This is the way we’ve always done it” and “If it ain’t broke, don’t fix it” are not valid reasons to maintain the status quo. Furthermore, digitizing is no longer a matter of outpacing competitors, it’s a question of just keeping up. Pharmaceutical manufacturers, according to McKinsey, “face a stark choice: Either evolve with the new era and build an organization that has digital at its core or risk losing ground.”1

Even pharmaceutical manufacturers that have digitized are held back by the siloed nature of their systems. When systems aren’t integrated and can’t communicate with each other, employees are forced to manually transfer data from one system to another, reintroducing the human error that digitizing was expected to fix. Isolated systems also have the same problems in supply chain visibility that slow down the recall process and result in wasted time and product.

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