August 17, 2023
By: Isabell Bücher
Your guide to improving quality control in pharma manufacturing
Quality control, or QC, is important in every manufacturing vertical, but it’s arguably the most crucial in pharma manufacturing, where even a minor drop in quality could compromise patient safety. Innovative technology from pharma 4.0 is bringing new and better solutions that make it possible for pharma plants to enhance QC while also increasing operational efficiency and productivity.
As drugs and medications become more complex, regulations crop up in different regions, and production processes grow more extensive, QC is becoming more pressured. It doesn’t help that many newer drugs, like antibody-drug conjugates (ADCs) used to treat many types of cancer, are more difficult to test for safety, efficacy, and consistency.
At the same time, plants need to maintain production levels to keep up with demand. Streamlining QC processes to be more efficient and reliable is thus becoming a significant differentiator in the competitive world of pharma manufacturing.
Why is quality control important in pharma manufacturing?
Pharma plants carry a big responsibility. They produce medications, drugs, and therapeutic products that patients and healthcare personnel rely on, and any quality changes could lead to great harm.
Pharma manufacturing plants also need to comply with regulations around production processes and quality assurance, and those regulations are increasing all the time. Plants that serve an international market may have to consider numerous overlapping regulations from bodies like the FDA in the US, the EMA in Europe, the MHRA in the UK, the CDSCO in India, as well as international bodies like the World Health Organization (WHO), the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) , and many more. Lack of compliance can result in significant fines or other penalties.
Additionally, pharma companies face potential reputational damage from recalling poor-quality batches. High-profile recalls can damage trust among end users, and plants which gain a reputation for frequent recalls will see a drop in demand as customers go elsewhere.
Last but not least, poor-quality products have to be destroyed. If QC processes fail, it means a waste of resources, raw materials, and energy, water, and labor that was used in production, causing potentially significant losses for the plant.
As a result, quality control processes need to be robust and reliable. QC includes testing batch samples for strength, uniformity, bioavailability, purity or lack of contamination, and more. In most plants, QC protocols include monitoring processes throughout production, to ensure that they always follow best practices and regulatory requirements.
What are the benefits of quality control in pharma?
The benefits of improved quality control in pharma plants are more extensive than you might think. On the simplest level, plants with stronger QC systems are more likely to pick up on defects early in the production process. By catching and correcting issues early, manufacturers can avoid expensive recalls, rework, and disposal of substandard products, thereby reducing waste and production costs.
The benefits continue to stack up. Effective QC controls throughout the supply chain improve efficiency and lower the risk of poor quality raw materials reaching the production line and propagating defects downstream, when they become more costly to resolve. Plants with a reputation for robust QC, consistently high-quality products, and few recall incidents will see more customers, increased revenue, and greater profits.
What’s more, QC systems that are integrated into manufacturing operations can boost productivity and operational efficiency across the entire plant. They ensure that deviations are detected and addressed promptly, helping prevent bottlenecks from arising and minimizing disruptions and downtime. Good QC consists of a cycle of monitoring, analysis, and continuous improvement that leads to the optimization of manufacturing methods, enhanced product quality, and better resource utilization.
How to improve QC in pharma
There are a number of ways that pharma plants can raise their QC game.
- Automation technology is faster and more accurate
Manual checks are prone to error and can be unreliable. It also takes time to receive the results from manual tests, which can cause delays in production and shipping. But automated systems can operate much faster and with greater accuracy, running real time tests for potency, purity, and more in a fraction of the time it would take for manual checks.
AI technology like computer vision can “see” inside products to spot signs of contamination or impurities, and pick up on damage to packaging far more quickly. This reduces the risk of errors and streamlines QC processes.
- Predictive monitoring proactively identify trends
Predictive analytics and monitoring can identify patterns and trends that could indicate bottlenecks in production and defective processes, which may in turn undermine product quality. They can also deliver alerts and notifications as soon as they spot any deviation from established quality parameters.
With early warnings, process engineers can intervene promptly and take corrective actions before defects escalate, and/or prevent poor quality product from continuing through the process, reducing the likelihood of recalls or delays.
Predictive monitoring tools can also assess risks for quality issues, allowing plant managers to make better data-driven decisions about resource allocation and the timing of interventions and repairs. In this way, predictive monitoring turns QC into a proactive, data-driven process rather than a reactive one, enhancing product quality, reducing risks, and optimizing manufacturing efficiency and resource utilization.
- Quality by Design builds QC into the culture
Quality by Design, or QbD, is a culture that builds quality into the manufacturing process, rather than leaving QC checks for the end of production when there’s no choice but to destroy the failed product. With automation, it’s also possible to monitor production lines constantly to spot defects in real time, correct mistakes, and rescue product that would otherwise have gone to waste.
By understanding the impact of various parameters on product quality and utilizing risk assessment tools, manufacturers can optimize processes to consistently produce high-quality pharmaceuticals. This allows them to design production systems with built-in quality assurance, reducing the need for extensive end-product testing.
- Supply chain quality management
Quality control extends beyond the plant, encompassing suppliers and vendors. If the raw materials are not high in quality, they’ll result in poor quality products that can’t be sold. Strong relationships and effective communication with suppliers can help ensure the consistency and reliability of raw materials and components.
Predictive monitoring can also assess the quality of raw materials, components, and intermediates as they arrive, enabling manufacturers to select reliable suppliers and ensure consistent input quality. By identifying potential supply chain disruptions early, manufacturers can take proactive steps to maintain quality standards.
- Strong governance ensures compliance
Robust documentation practices, comprehensive records, and clear procedures are the cornerstone for QC. Effective risk assessments also help manufacturers take preemptive measures to mitigate risks.
Good governance makes it possible for plants to demonstrate compliance with regulations, identify potential sources of variability, and assess raw materials, process steps, equipment, and environmental conditions for their impact on quality.
Raising the bar for QC in pharma
With the help of robust governance, advanced technology like automation and predictive analytics and predictive monitoring, and supply chain management, pharma manufacturers can significantly enhance their QC systems. Strengthening quality control processes and protocols helps ensure consistent product quality, reduce costs, and improve plant reputation, ultimately leading to increased revenue and higher profits.
