Quality Risk Management in Pharmaceutical Industry

When considering a new contract development and manufacturing organization (CDMO), it’s essential to evaluate how the organization ensures quality and whether it applies the latest approaches to risk management.

In carrying out this assessment, it’s helpful to consider five core elements: the pharmaceutical quality system; training and continuing education; automation and digitization; internal audits; and quality risk management.

An examination of these five elements at Neuland reveals how the company’s culture and systems work together. The Neuland approach recognizes that ensuring quality relies on consistent actions and awareness—every day, all year long. It requires robust systems, implemented through standard practices and reinforced by a culture of continuous improvement—a culture that starts with senior leadership and includes every employee throughout the organization.

1. The Pharmaceutical Quality System

   The pharmaceutical quality system is fundamental to a CDMO’s ability to ensure quality. It provides a structured framework for maintaining compliance with good manufacturing practice (GMP) regulations to deliver products that consistently meet specifications. This overarching system ensures that manufacturing processes are maintained in a state of control.

   Neuland takes pride in its pharmaceutical quality system. Key elements include stringent documentation practices, change-control procedures, and deviation management. The system also encompasses aspects such as corrective and preventive actions, supplier qualification, and continuous process verification.

   All these elements work together to create a system that ensures product quality through proper design, monitoring, and control of manufacturing processes and facilities.

2. Training and Continuing Education

   Staff training and ongoing education are critical for ensuring quality. A CDMO’s employees should participate in regular mandatory training sessions on GXP compliance, to keep skills sharp and knowledge up to date.

   Neuland staff undergo comprehensive GXP training, with managers ensuring that educational programs are thorough, appropriate to each role, and conducted at the correct intervals

   Neuland’s leadership also knows that continuing education cannot be limited to operators on the manufacturing floor. As an organization that is truly committed to continuous improvement, Neuland requires appropriate ongoing education and training for all levels, including senior management. The commitment to quality, and the culture of excellence, start at the top.

3. Automation and Digitization

   While a quality system must put a heavy emphasis on people and training, quality control can often be improved and strengthened through automation and digitization.

   Neuland is continuously investing in new technologies. The company has deployed Integrated Quality Management System comprising of Applications like Empower CDS, laboratory information management system (LIMS), a quality assurance management system (QAMS), to ensure consistent workflows and accurate data capture. The company uses tools like Minitab and QbD systems analyzing data with Statistical techniques for process validations. The company is in process of deploying next gen ERP System - SAP S4 HANA across the enterprise offering real time data processing and visibility. Real-time data monitoring with a supervisory control and data acquisition (SCADA) system enables Neuland staff to quickly identify problems in devices and sensors, for swift resolution and reduced risk.

4. Regulatory Inspections and Internal Quality Audits

   An established CDMO will have been inspected many times. Neuland has passed more than 40 inspections from regulatory agencies around the world, including the United States, Europe, Mexico, Japan, Korea, and Australia.

   Of course, regulatory inspections are not sufficient to ensure quality day after day, all year long. As part of its pharmaceutical quality system, Neuland conducts regular internal audits and self-inspection. An annual internal audit is conducted by the corporate quality assurance (QA) department, and self-inspection is carried out twice-yearly audits by each site’s QA team, including subject-matter experts from production, quality control (QC), engineering, and the warehouse, with the head of QA as the lead auditor. These corporate and site audits evaluate all aspects of the quality system.

5. Quality Risk Management

   A risk management program is essential for an effective quality system. This program directly reduces risk by identifying risks and implementing steps to address them. This process also enables the organization to focus its attention where it is most needed, facilitating an effective use of resources for greater quality assurance and an efficient operation.

   Risk assessments should address a broad array of factors that affect product quality, such as input materials, suppliers, manufacturing and testing processes, cleaning, the introduction of new products and systems, and major changes to processes and systems.

While many CDMOs focus on risk response, Neuland emphasizes proactive risk prevention. Neuland’s strong risk-management program includes several critical aspects:

• comprehensive risk identification, via a thorough process that considers all potential sources of risk, including supply chain vulnerabilities, regulatory changes, and technological advances;
• quantitative risk analysis, to prioritize risks and allocate resources appropriately;
• cross-functional collaboration, to provide a complete view of risks and enhance the effectiveness of mitigation strategies;
• risk communication, both internally among decision makers, and externally, with regulatory bodies, suppliers, and customers, to keep all stakeholders apprised of changes;
• dynamic and continuous monitoring (sometimes referred to as risk review), including updating risk registers and revisiting risk mitigation strategies regularly;
• learning from other industries, such as the energy and materials sectors, which have mature risk management frameworks that can be adapted to the pharmaceutical context.

Many companies focus on obvious risks but may overlook less apparent ones. Neuland’s thorough approach ensures that all risks are considered and mitigated.

Quality and Risk Management at Neuland

Neuland’s proactive quality culture permeates the entire organization, and quality is integrated into all work practices. Ongoing training, for corporate leaders through operators on the factory floor—and including the more than 330 staff in QA and QC—promotes a culture of continuous improvement. An internal awards program further fosters quality by recognizing and rewarding excellence.

A robust risk-management program, integrated into Neuland’s pharmaceutical quality system, ensures that risk assessments are thorough and comprehensive. Ongoing risk review keeps assessments up to date with any process or material changes. 

Regular self-audits, conducted by cross-functional teams, provide essential checks on equipment, procedures, and training. With continuous investments in automation and digitization, the company applies the latest technologies to enhance quality control.

Neuland knows that a quality of culture, implemented through a robust quality system and effective risk management, provides the outcomes and quality product that every customer needs.

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