Patterns in the present population give pharmaceutical companies a dual challenge. On one side, the aging population is increasing rapidly. A new UN study forecasts that the 65+ age group will rise from 9% to 16% worldwide by 2050, and the 80+ group is projected to triple. Yet, about 30% of the global population lacks access to essential medicines. As people live longer with better access to healthcare, the demand for pharmaceuticals intensifies.
However, increasing production has its hurdles. The pharmaceutical industry faces disruptions, with facility or product quality failures being the leading cause of drug shortages, accounting for 66% of shortages. Manufacturers must adopt innovative technologies to meet this demand and improve the drug lifecycle.
Key Risk Factors for Pharmaceutical Manufacturing
1. Managing Environmental Conditions
Optimal environmental conditions are crucial in production and storage. Poorly managed conditions can lead to quality control failures, regulatory violations, and energy inefficiencies. In fact, 60% of electrical energy is consumed by environmental control, with about 8% wasted annually.
Solution: A dedicated system to monitor and control environmental conditions, continuous energy monitoring, and adherence to regulatory standards can enhance quality and reduce energy usage.
2. Physical Infrastructure Failure
The integrity of utilities and plant equipment is vital. Power disruptions, even minor ones, can cause sterility loss, equipment failure, and product loss. Ensuring a stable power supply is essential for maintaining data integrity and avoiding costly IT failures.
Solution: On/off-site renewable energy sources can help ease the strain on public grids. Advanced technologies like AI, simulations, and IIoT sensors can prevent equipment failures by enabling real-time monitoring and analysis.
3. Non-compliance
Regulatory requirements ensure drug safety. However, data issues account for 79% of FDA warning letters in the last five years. Non-compliance due to missing or incorrect data can lead to production delays, fines, or license suspensions. Cybersecurity threats also play a role in non-compliance, with two-thirds of pharmaceutical companies experiencing data breaches.
Solution: Digitizing workflows and validation processes can help ensure regulatory compliance, improve data integrity, and reduce human error. Implementing cybersecurity measures is also essential to protect data.
4. Being Responsive to Operational Issues
Agility is key for pharmaceutical manufacturers to adapt to incidents and changing needs. Complex systems and a lack of standardized procedures can hinder responsiveness and increase operational costs.
Solution: Implementing standard operating procedures (SOPs) across facilities can help streamline responses to incidents. Digital twins, AI, and cloud technology enable real-time data analysis to improve decision-making and efficiency.
5. Sustainability Challenges
Energy management and sustainability are critical business drivers. Efficient energy, water, and waste management reduce costs and improve brand reputation, contributing to financial gains and investor confidence.
Solution: Centralized platforms for monitoring energy consumption and sustainability KPIs allow companies to track progress towards carbon-neutral goals. Transitioning to renewable energy sources also supports sustainability efforts.
The Power of Digitization
Pharmaceutical companies face immense pressure to meet product demand while achieving operational efficiencies and sustainability goals. Cutting-edge facilities must embrace innovative technologies like AI and data digitization to improve decision-making, ensure regulatory compliance, and drive sustainability in pharmaceutical manufacturing.
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