Crafting a Pharma Manufacturing Strategy Rooted in Value: The Four Pillars

The business of making and selling drugs is a very sensitive and competitive area where the risk is very huge. Thus, the imperative to develop new treatments rapidly, while maintaining safety and efficacy at a reasonable cost, has never been stronger. In this regard, manufacturing strategy is not just a support function at the end line but an essential tool for business success.

A sound manufacturing plan provides businesses with the ability to increase production to meet demand and maintain product quality while adhering to high standards of product recall and risk management at a reasonable expense. But the attainment of these objectives, as you might agree, is easier said than done. It involves a strategic mind set that links production with business strategies as well as incorporating the current technological inventions.

Furthermore, the environment in which it operates is dynamic and challenging and has some changes including supply chain risks, escalation of complications within production networks, and raw material costs. Such challenges call for preventive measures that entail a manufacturing system that is designed in such a way that potential problems are prevented from happening and flexibility in case something happens.

In more detail, four specific approaches are presented below that can assist pharmaceutical companies not only in addressing these challenges but in leveraging them in order to deliver higher value. These approaches, including the adoption of the latest technology, and effective supply chain management, are aimed at making your manufacturing operations not only efficient but also robust and effective for the long haul. We will also expand on the tendency that may cause failure of a manufacture refresh and how to avoid them with timely case studies.

Whether you are seeking to provide additional value to your current processes or planning a major shift in your manufacturing approach, below are the practical advice to make sure that your improvements will give tangible benefits to your organization.

Pillar 1: Leveraging Advanced Technologies

Adopting cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), and automation can revolutionize pharmaceutical manufacturing. These technologies enable predictive maintenance, reduce downtime, and enhance production efficiency. For instance, predictive analytics can foresee equipment failures, allowing preemptive action and minimizing production halts.

• Digital Transformation: Embrace technologies like AI, IoT, and automation to streamline processes, improve efficiency, and enhance data-driven decision-making.
• Real-time Monitoring: Implement real-time monitoring systems to track production parameters, identify potential issues early, and ensure product quality.
• Predictive Analytics: Utilize predictive analytics to forecast demand, optimize inventory levels, and mitigate supply chain disruptions.

Use Case: Predictive Analytics for Equipment Maintenance

Scenario: A global pharmaceutical manufacturer was experiencing frequent unplanned downtime due to equipment failures, leading to production delays and increased operational costs. The company decided to implement a predictive analytics solution using AI and machine learning to monitor equipment health in real time.

Implementation: Sensors were installed on critical machinery across the production lines, continuously collecting data such as temperature, vibration, and pressure. This data was fed into a machine learning model that analyzed patterns and identified early signs of potential failures. The system could predict when a piece of equipment was likely to fail and triggered maintenance alerts before any issues occurred.

Outcome: As a result, the company saw a 30% reduction in unplanned downtime. Maintenance could be scheduled during non-peak hours, minimizing disruption. The proactive approach not only saved costs associated with emergency repairs but also improved overall production efficiency, ensuring consistent product output.

Pillar 2: Ensuring Regulatory Compliance and Quality Control

Compliance with stringent regulatory standards is non-negotiable in the pharma industry. Integrating quality control processes with real-time monitoring ensures that products meet regulatory standards throughout the production lifecycle. This reduces the risk of costly recalls and regulatory penalties.

• Robust Quality Management Systems (QMS): Establish robust QMS to ensure adherence to regulatory standards like GMP, FDA, and ICH guidelines.
• Risk Assessment and Mitigation: Conduct thorough risk assessments to identify potential risks and implement effective mitigation strategies.
• Continuous Auditing and Improvement: Conduct regular audits to assess compliance and identify areas for improvement.

Use Case: Real-Time Quality Monitoring with IoT

Scenario: A biotech company was struggling with maintaining consistent product quality across its manufacturing sites. Variations in environmental conditions, such as temperature and humidity, were impacting the quality of biologic products, leading to a higher rate of batch rejections.

Implementation: The company deployed IoT sensors throughout its production facilities to monitor environmental conditions in real time. These sensors provided continuous data on factors like temperature, humidity, and pressure, which were crucial for maintaining product integrity. The data was integrated into a centralized quality control system, enabling immediate detection of deviations.

Outcome: With real-time monitoring, the company could swiftly address any deviations from the required conditions, ensuring that each batch met strict quality standards. This reduced batch rejection rates by 25%, resulting in significant cost savings and ensuring compliance with FDA regulations. The approach also boosted the company’s reputation for delivering high-quality products consistently.

Pillar 3: Optimizing Supply Chain Efficiency

A well-optimized supply chain is critical to ensuring that products are delivered on time and at the right cost. Strategies such as just-in-time (JIT) inventory management and digital supply chain tracking can significantly improve efficiency and reduce waste.

• Supplier Relationship Management: Foster strong relationships with suppliers to ensure reliable supply of raw materials and components.
• Inventory Management: Optimize inventory levels to minimize costs and avoid stockouts or excess inventory.
• Supply Chain Visibility: Implement technologies to gain real-time visibility into the supply chain and identify potential bottlenecks.

Use Case: Blockchain-Enabled Just-in-Time Inventory Management

Scenario: A multinational pharmaceutical company faced challenges with managing its complex supply chain, which involved multiple suppliers across different countries. Delays in raw material deliveries and inefficiencies in inventory management were leading to production bottlenecks and increased costs.

Implementation: The company implemented a blockchain-enabled just-in-time (JIT) inventory management system. Blockchain technology provided a secure, transparent, and immutable record of all transactions within the supply chain, allowing real-time tracking of materials from suppliers to production facilities. This visibility enabled the company to optimize inventory levels, ordering materials only when needed and reducing excess stock.

Outcome: The blockchain system improved supply chain transparency, reducing lead times and ensuring materials were available exactly when needed. Inventory costs decreased by 20%, and the time-to-market for new products was shortened by 15%. The system also enhanced trust among supply chain partners, as all parties had access to the same real-time data, reducing disputes and improving collaboration.

Pillar 4: Fostering Continuous Improvement and Innovation

The pharma industry is ever-evolving, and staying ahead requires continuous improvement and innovation. Encouraging a culture of innovation, investing in R&D, and regularly revisiting manufacturing processes to incorporate the latest advancements are key to sustained value delivery.

• Lean Manufacturing Principles: Adopt lean manufacturing principles to eliminate waste, improve efficiency, and reduce costs.
• Innovation and R&D: Invest in research and development to develop new products and improve existing ones.
• Employee Engagement and Training: Foster a culture of continuous learning and innovation through employee training and development programs.

Use Case: Employee-Driven Innovation Program

Scenario: A pharmaceutical manufacturer recognized that staying competitive required continuous process improvement and innovation. However, innovation efforts were sporadic and primarily driven by top management, resulting in limited employee engagement.

Implementation: The company launched an employee-driven innovation program, encouraging staff at all levels to contribute ideas for improving manufacturing processes. A dedicated platform was created where employees could submit their ideas, which were then evaluated by a cross-functional team. The program also included incentives, such as recognition and financial rewards, for ideas that led to significant improvements.

Outcome: One of the standout ideas came from a production line worker who suggested a change in the sequence of operations for a particular drug formulation. This simple change led to a 15% increase in yield and a 10% reduction in production time. The program not only improved operational efficiency but also fostered a culture of continuous improvement, where employees felt empowered to contribute to the company’s success. Over time, the cumulative impact of these employee-driven innovations resulted in substantial cost savings and increased the company’s competitive edge in the market.

Common Pitfalls That Could Derail a Manufacturing Refresh

1. Overlooking Regulatory Updates

Failing to keep up with the latest regulatory changes can lead to non-compliance, resulting in costly fines and product recalls.

Scenario: A pharmaceutical company implements a new manufacturing process but fails to stay updated with recent changes in FDA regulations. As a result, the new process inadvertently violates compliance standards, leading to a product recall and a hefty fine.

Remediation:

• Regular Training: Ensure that compliance teams receive ongoing training on the latest regulatory updates.
• Automated Alerts: Use regulatory compliance software to receive automated alerts about changes in regulations.
• Internal Audits: Conduct regular internal audits to verify that manufacturing processes align with current regulations.

2. Ignoring Data Integration Needs

Siloed data can prevent a holistic view of the manufacturing process, leading to inefficiencies and missed opportunities for optimization.

Scenario: A company integrates a new ERP system to streamline operations but does not fully integrate it with existing data sources. This siloed approach leads to incomplete data visibility, causing inefficiencies in inventory management and production scheduling.

Remediation:

• Holistic Integration: Implement a comprehensive data integration strategy to unify all relevant data sources.
• Data Governance: Establish robust data governance policies to ensure data accuracy and consistency across systems.
• Real-Time Dashboards: Utilize real-time dashboards and analytics tools to provide a unified view of data and facilitate informed decision-making.

3. Resistance to Change

Employees may resist adopting new technologies or processes, which can stall progress and reduce the effectiveness of a manufacturing refresh.

Scenario: A company introduces a new automation system to improve production efficiency, but employees are resistant to the change. The reluctance to adapt leads to underutilization of the new system and minimal improvements in production efficiency.

Remediation:

• Change Management: Implement a structured change management plan that includes clear communication, training, and support for employees.
• Engage Stakeholders: Involve employees in the planning and implementation phases to address their concerns and gather feedback.
• Continuous Support: Provide ongoing support and resources to help employees adapt to new technologies and processes.

4. Underestimating the Complexity of Supply Chains:

A failure to understand and manage the complexities of global supply chains can lead to delays, increased costs, and disruption in product availability.

Scenario: A pharmaceutical company switches to a new supplier to reduce costs, but fails to thoroughly assess the new supplier’s capabilities and reliability. This oversight results in delays and disruptions in the supply chain, impacting product availability and customer satisfaction.

Remediation:

• Supplier Evaluation: Conduct thorough evaluations and audits of potential suppliers to ensure they meet quality and reliability standards.
• Supply Chain Mapping: Map out the entire supply chain to understand dependencies and potential risks.
• Contingency Planning: Develop contingency plans and maintain relationships with backup suppliers to mitigate risks and ensure continuity in case of disruptions.

Conclusion

Ensuring that your pharma manufacturing strategy delivers value is a complex but essential task. By leveraging advanced technologies, maintaining rigorous quality control, optimizing the supply chain, and fostering a culture of continuous improvement, companies can navigate the challenges of the industry and achieve sustained success. Avoiding common pitfalls, such as resistance to change and ignoring regulatory updates, is equally crucial to maintaining momentum and achieving long-term value.

About the Author:

Anshuman Dubey is a seasoned Senior Business Consultant at Infosys Consulting with more than 16 years of extensive proficiency in data products, Data-Mart, data governance, data modeling, security, data visualization, and data consulting. He boasts a proven track record of executing mission-critical projects across diverse facets of the life sciences and healthcare sectors, spanning commercial and operational domains. Anshuman excels in both agile methodologies and waterfall approaches, demonstrating effective collaboration with cross-functional teams throughout his career.