3 Challenges to Commissioning and Validating Pharmaceutical Assets in 2017

Strong enterprise asset management in the pharmaceutical industry requires equally strong commissioning and validation processes.

In the pharmaceutical industry, the execution of commissioning and validation activities has never faced greater difficulty. As the industry strives toward excellence in enterprise asset management, what challenges must it rise above?

3 Pharmaceutical Challenges in 2017

1. Commissioning new assets against markets and margins

Generic drug makers have eroded profitability for name-brand pharmaceuticals. In the six years between 2012 and 2018, one PricewaterhouseCoopers (PwC) report estimates those losses to the tune of $148 billion. That same report cited a Tufts University study that placed the average research and development costs for one new molecule at more than $1 billion. PwC challenged those figures. In some instances, costs could be four times higher.

As important as innovation is to the future of pharma, there is little capital lying around for the commissioning new assets or the recommissioning of assets taken offline. Heightened risk landscapes put asset managers and commissioning engineers between a rock and a hard place when constructing machinery or expanding facilities. Any project setback could become a financial death knell, but staying the course without adapting may prove just as fatal.

2. Data transparency amid strict regulatory environments

Smooth validation processes – drafting protocols based on specifications, seeking approvals from regulators and carrying out those accepted systems accurately – requires the free flow of technical, operational and safety data among all stakeholders.

Compliance with good manufacturing practices enhances consumer safety and brand loyalty, but aligning to strict Food and Drug Administration guidelines as they evolve may burden validation projects that lack data visibility. Validation is, by nature, evidentiary. Without information regarding proof of process, accessible when needed, pharmaceutical companies cannot expect to manage projects efficiently. Stringency here is particularly vital for businesses onlining used assets, as the costs of an extended validation process can diminish the value of purchasing surplus equipment without warranties.

3. Outcome-based value modeling for contracting with health care providers

Several major U.S. health insurers now build drug efficacy into contracts with pharmaceutical companies. According to Forbes Contributor and former health care reporter Bruce Japsen, Aetna, Anthem, Cigna, UnitedHealth Group, and Blue Cross and Blue Shield are among the growing number of insurers that demand that drug makers be reimbursed based on patient outcomes and not volume of products sold.

The commissioning and validation of pharmaceutical assets plays somewhat obviously into this paradigm shift. Greater attention paid to how drug-producing assets are built and maintained will directly impact their reputations. However, as previously discussed, challenging market conditions will act as a countervailing force to how companies will allocate C&V resources to that end.

To maximize spend on commissioning and validation, consider investing in independent inspection and design verification services through ABS Group, the parent company of GenesisSolutions. ABS Group provides third-party review for new builds, modifications or demonstrator projects, as well as verification process optimization and overall project management strategies for pharmaceutical leaders.

Contact GenesisSolutions or ABS Group today to learn more about how our experts can leverage their years of expertise and help you construct safe, efficient commissioning and validation processes.