However, an ageing population increases the demand for healthcare at a time when 30% of the population already has no access to essential medicines. The pharmaceutical industry faces both a long-term challenge and an opportunity to produce medicines and treatments in greater quantities, such as those used to manage conditions in later life.
Increasing the capacity of manufacturers to meet future demand is vitally important. Failures in product or facility quality cause 66% of all drug shortages, whereas failure to comply with stringent regulations throughout the pharma and life sciences industries can also result in significant cost penalties, which have increased by 43% globallyduring the past decade.1,2
This article examines five important areas that pharmaceutical facilities need to be aware of to transform their operations and improve production.
Controlling environmental factors
Pharmaceutical production and storage both require optimised conditions. Poor management of the production environment and product lifecycle can impact quality standards and risk regulatory violations and delayed approvals, slowing the release of products. It can also unnecessarily increase the use of energy.
Currently, 60% of electrical energy is consumed by environmental control and approximately 8% of energy is lost per annum owing to failures to monitor and manage environmental conditions accurately.3 Poorly managed environmental conditions often deteriorate equipment, producing an inconsistent final product. This presents financial and environmental costs for the business, impairing productivity and sustainability efforts.
Plant operations need to be highly responsive to maintain production and minimise the impact of disruption. All drug manufacturers must comply with good manufacturing practices (GMP) — a system to ensure that products are consistently produced and controlled according to quality standards.
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, they also have the added benefit of controlling energy use.
Failure of the physical infrastructure
Maintaining plant equipment and utilities is paramount. The cost of replacing specialist infrastructure is high and has significant knock-on effects on production owing to the downtime involved. An unreliable power supply can lead to momentary dropouts, brownouts or complete failure … and even the briefest break in power continuity can result in loss of sterility, failure of crucial assets and product loss. Effective strategies are needed to maintain critical infrastructure.
As companies look to revamp their physical infrastructures, simulation allows them to conduct real-time tests and gain insight without disruption. Artificial intelligence, virtual reality and augmented reality can also address the risks of physical infrastructure failure.
Advancements in analytics have shifted from historical operational dashboards to real-time analysis — diagnosing and visualising data from the plant without having physical contact with machinery, robots or control enclosures through the industrial internet of things (IIoT) sensors.
With global power demand mounting and the strain on national utility grids clear, a combination of on and off-site renewable energy is often used to supplement grid usage. Once the infrastructure is in place, renewable energy provides a source of power that meets sustainability targets and takes the pressure off grids.
Using data for compliance
Regulatory requirements are in place to ensure that medicines are safe for consumption and failure to comply comes with a hefty cost. It is estimated that non-compliance costs 2.71 times more than maintaining or meeting compliance.4
Data is crucial to inform key decisions and ensure requirements are honoured; this is one of the industry’s biggest challenges. The US FDA, for example, found incorrect data in 79% of drug warning letters during the last 5 years. Missing or inaccurate data can itself lead to non-noncompliance, delays or even shutdowns in production.
Additionally, two thirds of pharmaceutical companies have suffered serious data breaches because of cyber hacking, with the cost impact running into the millions alongside the reputational damage that follows a breach. Whether non-compliance stems from incorrect data or not, manufacturing companies often receive hefty fines and license suspension — or removal — if found to be in breach of regulation.
In addition, digitising operations and workflow management helps to reduce the risk of human error, one of the biggest risks to quality control.
This helps to guide employees correctly and ensure that the proper steps are followed. Digitising document validation processes in a digital environment saves time and enables companies to adhere to regulatory requirements, promote data integrity and ensure complete traceability throughout the lifecycle.
Responding to operational concerns
The ability to quickly adjust to shifting requirements is essential for facilities. Failure to remain agile has much to do with system complexity, procedural restrictions and a lack of a standardised approach to incidents.
An overly complex system and a heavily loaded communication network can reduce the operator’s effectiveness. Constraints from numerous regulations, extensive signoffs and a lack of standard operating procedures (SOP) make it difficult for operators to resolve a situation quickly. This can have a considerable knock-on effect on production.
SOP adoption can be crucial when promoting agility throughout facilities. Without routine standardisation, complexity and undesirable variability can be introduced. Preconfigured standards help to streamline methods in cases when businesses must respond quickly and stop situations from getting worse.
Introducing a digitised dashboard means that data is easily viewed on devices, saving time and increasing efficiency. Through simulation, data modelling 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.
Operations and sustainability objectives
Overall, there is a societal perception that the pharma industry or Big Pharma is unconcerned about environmental impact, which they are working to reverse. Pharmaceutical businesses must prioritise energy management and sustainability to demonstrate how resources are managed to optimise production costs and meet sustainability obligations.
With data being generated from multiple locations at any one time, the ideal solution is a platform that provides central visibility and detailed reporting to manage these different data streams. Enterprise-wide visibility offers complete transparency to help develop and benchmark sustainability KPIs and track their progress towards company targets.
A robust energy monitoring and targeting tool can also 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 such as digital dashboards allow teams to modify goals or projects mid-cycle and track the progress of environmental objectives. Renewable energy plays a significant role in this, as switching to low or no carbon sources contributes to overall sustainability.
The power of digitalisation
Businesses in the pharma sector are under pressure to provide products that adhere to strict regulatory standards while also pursuing operational efficiencies and sustainability. Digitalisation enables companies to unite real-time data from previously siloed sources to provide contextualised information helping to drive business decisions, boost sustainability performance and ease regulatory compliance.
Utilising tools for digital project delivery of new facilities will accelerate the industry’s transformation. The next generation of manufacturing facilities will be adept at facing the risks and uncertainties that impact their production capabilities.
References
1. www.fda.gov/files/drugs/published/Strategic-Plan-for-Preventing-and-Mitigating-Drug-Shortages.pdf.
2. www.compliancequest.com/blog/the-cost-of-non-compliance/.
3. www.energystar.gov/sites/default/files/buildings/tools/Pharmaceutical_Energy_Guide.pdf.
4. https://businessinsights.bitdefender.com/costs-of-non-compliance-getting-higher#:~:text=Based%20on%20a%20recent%20report,%242.2%20million%20to%20%2439.2%20million.