“As we operate in a highly regulated environment, being on top of all possible high-risk areas is essential,” said Robert Nass, Head of Quality & Regulatory Management, MilliporeSigma.
Critical aspects to risk mitigation/management in the pharmaceutical industry, according to Nass, are having:
- Global systems and oversight in place
- Local assessments by multidisciplinary teams and subject matter experts
- Regular evaluation
“The key is to get a sound understanding of the processes,” Nass explained.
The systematic assessment of influencing factors such as utilities, media, or raw materials is also important—in addition to determining risk mitigation measures and setting up regular evaluations.
“Areas of growing attention are more and more complex supply chain and risks coming from supplied materials,” said Nass.
Focus Areas
“Regulatory bodies look from two angles on risk management areas,” Nass explained, which are:
- Patient safety
- Drug availability
The latter of which is in order to avoid drug shortages.
Similar to regulatory bodies, pharmaceutical companies’ primary goal is patient safety. However, quality is also a high concern, as the quality of a drug will reflect upon a company’s operations.
One of the primary means to ensure transparency of operations are a number of new digital technologies that are coming onto the market.
“New digital technologies enable the availability of more data and better linkage of data to foster process understanding,” said Nass. “On the one hand, this enables higher transparency, but on the other hand this also means higher complexity, higher requirements, and more attention to data integrity.”
Formal & Informal Risk-Management
“Both processes are important,” said Nass when asked about formal vs. informal risk management processes.
“A formal risk-management process is essential, especially for a globally operating company,” he continued. “To measure, compare, control, and improve procedures and processes, standardized tools are necessary. But depending on the size of the event or the problem, an informal risk-management process can work as well—e.g., employees collaborating and doing best-practice sharing beyond sites and countries.
“Overall, it is important that risk management is part of the quality culture.”
Trends
According to Nass, risk management trends in the pharmaceutical industry that we can expect to see more of going forward include the following:
- Globalized risk management systems
- Bringing all elements of the Quality Management System under one umbrella
- Providing risk management across the full lifecycle of a product
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