Five Ways Pharma Companies Can Keep Up With Demand
Trends in today’s population provide pharmaceutical companies with a dual-pronged challenge. On one side of the spectrum the population is getting older – a recent UN study forecasted the 65+ age group is set to rise from 9% to 16% globally by 2050, and 80+ age group is projected to triple. Yet, the same study shows around 30% of the population have no access to essential medicines. As people are living longer with better access to medicine, our reliance on medicine increases as we age as well. It is because of this combination pharmaceutical companies face a growing demand.
However, producing more medicine would be challenging as the manufacturing industry already faces disruption, with failures in product or facility quality being the leading cause of disruption to manufacturing, resulting in 66% of all drug shortages. It is, therefore, imperative for drug manufacturers to accelerate the adoption of innovative technologies to address the situation and bring transformational changes to the way the lifecycle of medicinal products are managed.
This listicle will explore five key risk factors pharmaceutical facilities need to understand, which they can then ultimately renovate to improve output.
1. Managing environmental conditions
In all areas of production and storage, optimal environmental conditions are fundamental for production. Without a highly responsive plant, process control and operations can be disrupted in multiple ways.
All drug manufacturers must comply with good manufacturing practices (GMP). GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. Poorly managed environmental conditions can lead to poor quality standards, regulatory violations and delayed approvals, which only slows the release of products. Not only does this hamper regulatory compliance but ineffective lifecycle management also poses a potential increase in energy use.
Already, 60% of electrical energy is consumed by the control of the environment. Approximately 8% of energy is lost per annum without correct monitoring and management of environmental conditions. Poorly managed environmental conditions often lead to deteriorating equipment, creating more variable product quality. This presents financial and environmental costs for the business, impairing productivity and sustainability efforts.
Solution:
Three things are needed to effectively maintain environmental conditions: a dedicated system to control and monitor environmental conditions, real-time energy monitoring and production correlation, and an awareness of effective regulatory compliance. Combined, not only will they manage environmental conditions, but they also have the added benefit of controlling energy use.
2. Physical infrastructure failure
The integrity of utilities and plant equipment in manufacturing facilities is vital. Power availability is the number one priority. Minor power interruptions and disruptions go unnoticeable in our daily lives but, momentary lapses of power continuity can hugely impact production, including loss of sterility, failure of critical assets and loss of product.
Unreliable power supply can lead to momentary dropouts, brownouts or complete failure, blackouts. During these moments effective strategies are needed to maintain critical infrastructure and ensure critical equipment doesn’t temporarily dropout or fail completely.
Power supply also supports data integrity. This is fundamental in ensuring quality throughout production and storage as it relies on accurate data. As much as data integrity is driven by power availability, properly managed IT equipment can prevent potential server failures due to power quality issues. Across all networks IT outages can mount rapidly – in some cases climbing to $300,000/hour – and the cost of physical infrastructure failure can be sizeable.
Pharmaceutical companies have the difficult job of maintaining infrastructure. Not only is it multifarious as the cost to modernize is high, replacing equipment can disrupt production due to the downtime it demands.
Solution:
With global power demand mounting and the strain on national utility grids clear, on/off site renewable energy is often used to supplement the grid usage. Once the infrastructure is in place, renewable energy provides a source of energy that meets sustainability targets and takes pressure off grids.
As companies look to revamp their physical infrastructures, simulation allows companies to carry out real time tests and gain insight without the disruption. Artificial intelligence, virtual reality and augmented reality can also address the risks of physical infrastructure failure. Advancements in analytics has allowed for a shift from historical operational dashboards to real-time analysis – diagnosing and visualizing data from the plant without having physical contact with machinery, robots, or control enclosures through industrial internet of things (IIoT) sensors.
3. Non-compliance
Regulatory requirements ensure medicines are safe for consumption. To honor these requirements data is used to fact check and make decisions. However, data has also been sighted as one of the top concerns related to the issuing of observation notices and warning letters by regulators. Infact, the FDA cited data on 79% of the drug warning letters over the last 5 years. Missing or inaccurate data can lead to non-conformance, which is likely to cause delays or, in the worst-case, cease production. Whether non-compliance stems from incorrect data or not, non-compliance from manufacturing companies often results in hefty fines and/or a license suspension or removal.
Additionally, cyber security has the potential to affect non-conformance. Two thrids of pharmaceutical companies have suffered serious data breaches due to hackers, with the cost impact running into the millions. If a company is non-compliant and products are recalled, or cyber-attacks are frequent, mistrust can develop which affects brand reputation too.
Solution:
Human error represents the biggest risk to quality control, so by digitizing operating procedures, solutions for workflow management help to guide employees correctly, ensuring the right steps are followed. Digitizing document validation processes in a digital environment not only saves time but helps companies adhere to regulatory requirements, promotes data integrity and ensures complete traceability throughout the lifecycle.
4. Being responsive to operational issues
Agility to adapt to incidents and changing requirements is indispensable for facilities. System complexity, procedural constraints and a lack of standard approach to incidents all have a hand in failure to maintain agile. An overly complex system, and heavily loaded communication network, can reduce the effectiveness of the operator. Constraints from numerous regulations and extensive signoffs for approval can restrict the capability of a team, particularly when time is limited. A lack of standard operating procedures (SOP) to manage each type of incident makes it difficult for operators to quickly resolve a situation.
Slow response times to critical issues can have a huge knock-on effect to production. If a system restores slowly, its impact extends beyond the initial incident. Without effective risk assessments to determine the correct level of criticality of system functionality there can be an increase in qualification activity which takes time, is costly and limits flexibility.
Solution:
Adopting SOPs across facilities can be key in facilitating agility. Without routine standardization you can introduce complexity and unwanted variability. In instances where companies need to react quickly and prevent situations escalating, pre-configured standards help simplify strategies.
Digital twins enable collaboration between stakeholders throughout the lifecycle of a facility through open interfaces within a digital ecosystem. Through simulation, data modeling, and analytics, businesses can make decisions based on real-time data on individual assets, processes or entire systems. By anticipating and avoiding operator error, efficiency and safety are boosted.
Introducing a digitized dashboard means data is easily viewed on devices, saving time, and increasing efficiency. Cloud technology and AI can also simplify time-consuming tasks by analyzing and providing actionable insights. The adoption of AI techniques and data analytics can reduce the complexity of crisis management training and operations, managing incidents with less time.
5. Operations impacting on sustainability goals
Energy management and sustainability are key business drivers for pharmaceutical companies and how energy, water and waste are managed impacts product costs and sustainability commitments.
With consumers taking an increased interest in sustainability performance, brands can gain positive recognition by introducing sustainability targets displaying their green credentials without appearing to be greenwashing.
This brand recognition can have the additional benefits of an economic effect as it may boost shareholder confidence or attract new investors. The weight of social responsibility means businesses should act in a manner that benefits society. Socially responsible companies should adopt policies that promote the well-being of both society and the environment, while lessening the negative impacts felt by both.
Solution:
With data being generated from multiple locations at any one time, the ideal solution is a platform which provides central visibility and detailed reporting to manage these different data streams. This enterprise-wide visibility provides complete transparency to helping develop and benchmark sustainability KPIs and track their progress towards company targets.
Additionally, a robust energy monitoring and targeting tool can compare and benchmark performance to identify energy efficiency and carbon net zero opportunities. This effectively provides a single source of information for projects to drive energy efficiency, water usage and the journey towards carbon net zero. Sharing platforms like digital dashboards allows teams to modify goals or projects mid-cycle, as needed to track the progress of environmental goals. Renewable energy plays a big role in this too, by switching to low or no carbon sources this gives a win on the sustainability front.
The power of digitization
Life sciences businesses are facing pressure to meet the demand of the stringent regulatory requirements for products whilst driving for operational efficiencies and sustainability.
Next-generation facilities need to be adept to face the risks and uncertainties that can impact on their production capabilities. The utilization of tools for digital project delivery of new facilities, will accelerate the industry’s transformation. Digitization enables companies to unite real-time data from previously siloed sources to provide contextualized information. This will help drive business decisions to boost sustainable performance and ease regulatory compliance. Drug manufacturers need to adopt innovative technologies to assist in modernizing the manufacturing of medicinal products.
