Changes to IP protection laws have left pharmaceutical manufacturers facing fierce competition and urgently looking for ways to streamline production, boost productivity and minimise downtime whilst adhering to a strict regulatory framework
With many pharmaceutical facilities now moving towards continuous operation, the threat of disruption to production looms large and is costlier than ever before.
Chris Whitehead, Managed Platform Product Manager at SolutionsPT, looks at the importance of disaster resilience and the solutions available to help protect pharmaceutical manufacturers from the loss of critical data and interruptions to production.
The pharmaceutical industry has not always needed to pay close attention to manufacturing costs; with generous margins and limited competition, the high price tag of finished drugs often compensated for any inefficiencies in production. However, the intellectual property (IP) landscape in pharmaceuticals has changed.
New competitors are emerging, increasing the pressure on manufacturers to fast-track new drug innovation, increase the speed at which they introduce new drugs to market and claw back profits with improved margins and better operational efficiency. As a result, innovators in the industry are realising that, as manufacturers, they need to adapt and improve their processes — and their first task is to increase efficiency and protect plants from downtime.
In a sector in which downtime can mean potentially huge financial losses, manufacturers in the pharmaceutical industry typically experience less unplanned downtime than those in other sectors. However, when disruption does happen, it is much costlier, with unforeseen downtime possibly leading to drug shortages, fines and compliance failures.
Pharmaceutical manufacturers are heavily regulated in terms of traceability and batch serialisation; as such, any downtime during a batch run will almost certainly ensure the entire batch has to be discarded as there would otherwise be no continuity in the batch data. Waste such as this has huge cost implications in terms of materials, time and profit.
Threats to continuity don’t just impact those who manufacture by batch. Many of the industry’s leaders are exploring continuous manufacturing as a route to increase quality, process throughput and profit.
Pharmaceuticals that are made using continuous production techniques are moved non-stop within the same facility and, although this approach delivers significant benefits to pharmaceutical businesses, from an operational perspective, it also creates a reliability challenge.
During batch production, quality testing would normally be done at regular intervals; but, during continuous manufacture, the production process doesn’t stop, so reliability and product quality must always be guaranteed.
Although machinery failure is a common cause of downtime, an increasingly pressing issue is cybersecurity. The 2017 attack on Merck saw a ransomware attack hit every location within the company, with the pharma giant suffering worldwide disruption and having to halt production of new drugs — negatively impacting the company’s bottom line.
An estimated 96% of ransomware victims lose access to their data for more than one day, heavily impacting production. With such a heavy reliance on operational technology (OT) systems to maintain uptime and productivity within the pharmaceutical space, it is essential to have disaster resilience and business continuity systems in place to ensure minimal impact across the plant should a ransomware attack strike.
From a patient safety perspective, pharmaceutical manufacturers have a public responsibility to ensure that there is no disruption to the production of drug substances and final drug products. Beyond the need to ensure the uninterrupted supply of vital medicines, drug companies also have a responsibility to mitigate threats to their business operations and assets. Building disaster resilience into the pharma manufacturing environment, rather than relying on back-ups, is therefore essential.
Traditional back-up solutions are often not specifically designed for OT systems and may present issues. For example, they often only perform a CRC check on the back-up data, which doesn’t provide assurance that systems could be fully recoverable. In addition, these back-ups are often only tested in a recovery scenario by support teams.
The latest managed disaster resilience services can highlight anomalous file level changes through continual monitoring. Back-ups are rigorously tested on a defined schedule by recovering the system in an “offline state” while checking key services, dependencies and, when applicable, integrity of critical databases and data sets.
With “hot standby” technology, systems can be quickly recovered with minimal downtime on primary or back-up hardware. Initial infection and lateral movement can also be tracked and contained, ensuring that critical pharma processes can continue while support teams investigate the outbreak and remediate the affects.
The demands of compliance, a highly competitive environment and the delivery requirements of a complex range of end customers, including hospitals, insurance firms, supermarkets and pharmacists, means that operational continuity is crucial in pharmaceutical manufacturing.
As a result, having a good business continuity and disaster resilience process in place is essential. Pharma businesses need to plan for what will happen when the worst happens and regularly test that plan.
Then, when something does go wrong, you’ve been through a disaster resilience shake-down test and the people and the teams are all in place, so everyone knows what needs to be done to get things back up and running as quickly as possible. If this is something that your operation would struggle with, considering an externally managed service could be the solution.