In heavily-regulated industries, the path of least resistance often means that processes stay the same, and the pharmaceutical industry is no exception. Between red tape and high-margin drugs that are brought to market under short-term patents, pharmaceutical companies must quickly recoup research and development costs while mitigating risk, leaving little incentive to proactively rework supply chain processes.
In the midst of this, many brands outsource the production of drugs, which relinquishes control of the production process. Without access to concrete data and information from these remote facilities, drug companies and contract manufacturers (CMOs) cannot confidently make necessary changes to prevent issues or improve the process, especially if it could jeopardize or stall production.
Now, progressive CMOs are realizing the value of operational data and, by implementing the right infrastructure, are giving drug companies unprecedented visibility into the production process. With these near real-time insights, the drug manufacturing supply chain model is on the brink of massive shift that will allow companies to bring drugs to market faster.
Development and Regulation
Quality is the number one concern of every drug manufacturer and, with every production run there are numerous outside variables that can diminish that quality. Things such as machine functionality, temperature, and volume can significantly alter a drug’s potency, effectiveness, or even availability. However, when production is outsourced, there’s one major problem: Delegating responsibility is not the same as delegating accountability. Regardless of whether a drug is produced in-house or by a CMO, in the eyes of the consumer, the pharmaceutical company will always assume any and all production risks.
Previously, disparate data sources made it difficult for pharma companies and CMOs to use operational data to understand asset performance and other variables in the production process. Data integrity issues meant that collected data couldn’t necessarily be trusted, especially when that data was patched together using numerous systems. Without a single infrastructure, analysts were left to guess or manipulate data, calling data integrity into question.
Accountability and Control with Data
However, as the industry turns toward analytics, both CMOs and pharmaceutical companies are realizing that quality data is nearly as valuable as the product itself. When a pharmaceutical company can remotely gather real-time insights from a single source of truth within each CMO, not only does the brand have unprecedented levels of transparency, the CMO can demonstrate manufacturing efficiency and product quality. The right collection, storage, access to and consumption of operational data allows companies to make decisions that lead to more cost-effective production, a shortened time to market, lower consumer prices, and a higher quality product.
Contributed by Petter Moree, Industry Principal at OSIsoft
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