How Digitization Is Transforming Quality Assurance and Quality Control Practices in Pharma?

The pharmaceutical industry is increasingly leveraging digital technology to improve its quality assurance and quality control processes. Digitalization has allowed for more efficient data and documentation management, improved production process monitoring, and more effective product quality analysis.

In this article, we will discuss the impact of digital technology on quality assurance (QA) and quality control (QC), look at current digital solutions, and analyze the challenges of these implementations.

Benefits of digitalization

Digital technology is revolutionizing the process of Quality Assurance and Quality Control. By leveraging digital tools, companies can achieve higher quality standards, reduce inefficiency, and generate cost savings. Here are some of the key benefits that digitalization can bring to QA and QC:

1. Increased Transparency and Traceability:

By leveraging digital technologies, companies can keep better track of the entirety of the production process. Digital systems enable traceability and provide greater transparency in each production and monitoring stage. A digital system can be configured to track, monitor, and analyze production data, which can identify and address potential quality issues while the production is still ongoing.

2. Improved data gathering and management:

Pharmaceutical businesses should use digitization technologies to reduce the risk of errors and improve the efficiency of their data collection. This data can come from various sources and these technologies could be used to quickly generate reports that help QA ensure the quality of the product. 

3. Enhanced Compliance:

Digital systems allow companies to ensure compliance with regulatory requirements. By capturing and recording data transactions electronically, companies can more easily maintain records and ensure that they are meeting the standards set by government and industry bodies. 

4. Increased visibility of the entire supply chain:

Digitalization allows businesses to integrate their supply chains and make more efficient use of their inventory levels and production planning. Pharmaceutical manufacturers particularly benefit from this enhanced visibility, as it provides them with valuable insights that can help them make better product quality decisions.

Overall, digital technologies are allowing companies to achieve higher levels of quality. By using digital tools to increase transparency, improve traceability and data gathering, enhance compliance, and increase the visibility of the supply chain, companies can reap the benefits of improved quality assurance and control.

Digital Solutions for Quality Assurance & Quality Control

Automated Data and Documentation Management

Automated data and document management systems are key to leveraging digital technology for improved quality assurance and quality control. By streamlining the process of collecting, categorizing, organizing, and storing data and documents, these tools can help organizations better meet compliance requirements and workplace safety regulations. With automated data and documentation management, companies can gather and analyze information more quickly, enabling them to identify and address problems and improve process efficiency. Automated data and document management systems can also track employee training status, ensuring that all staff is updated on the latest regulations and protocols. With these tools, organizations can more easily monitor, manage, and enforce quality assurance and quality control standards.

Production Process Monitoring

Production process monitoring is an essential part of quality assurance and quality control. By utilizing digital technology, it is easier than ever to ensure that all aspects of production processes adhere to specified standards. Automated process monitoring systems can be used to provide real-time monitoring and reporting, allowing for better oversight and faster corrective actions when needed. Additionally, digital tracking systems allow for the collection of data that can be used to better evaluate the performance of production processes and predict potential issues. By leveraging digital technologies, companies can have a better insight into the quality of their production processes, leading to improved product quality and customer satisfaction.

Case study: Clean Room Environmental Monitoring System

In the pharmaceutical industry, a clean room or aseptic area is necessary to produce sterile products that do not go through terminal sterilization. To guarantee the sterility and absence of pyrogens, the airflow, pressure, temperature, humidity, noise, vibration, and lighting must be controlled.

With digital technology, ISO specifications can be met by utilizing multiple environmental sensors combined with software and electronic systems that continuously measure and record differential pressure, temperature, and humidity. The operators can communicate with these systems with wireless tablets and can access real-time pressure, temperature, and humidity indicators. If one of the parameters of the clean room goes beyond the established thresholds, an alarm will notify operators and instructions will appear on the tablet. The obtained data can also be exported to spreadsheets for further analysis. Using a system like this one, real-time operational compliance can be ensured. 

Challenges of digitalization

Pharmaceutical companies that want to digitalize their operations and supply chains will face many difficulties. The implementation of these solutions needs to build systems in collaboration with numerous external partners throughout the supply chain. This will face resistance from other organizations and employees who are used to different ways of working. 

The regulatory aspect also brings another layer of complexity. The regulatory environment is a dynamic and rapidly changing system that will experience several changes with the widespread utilization of digital technologies. Regulators will need to gain more knowledge of digital technologies and modify regulations as new problems arise from the digitalization of the industry. Both regulators and Pharma organizations will face an adaptation stage until the digitalization process is complete. 

Pharma companies must have a well-rounded team of experts in their corner. The difficulty of having experts knowledgeable about pharma and digital solutions is that these two areas of expertise are vastly different. Pharma experts must be knowledgeable about the manufacturing process, the regulatory environment, and the complex pharmacology behind the production of pharmaceuticals. Digital experts must know coding, software engineering, and data analysis. Finding experts who are both knowledgeable in these two separate areas is a challenge, as the skills and knowledge required to excel in one field may not apply to the other.

Possible solutions for the challenges of digitalization

Successfully implementing a digitalization process relies on approaching the problem with a new perspective. Rather than depending on the traditional method of making large, comprehensive changes that require significant organizational resources and energy, it is better to focus on creating localized solutions that can be implemented quickly and scaled accordingly. The term “digitalization” covers a wide range of topics. It could be something as simple as replacing a data-entry book with a tablet to more complex procedures such as automatically transferring and analyzing measured data from the measuring equipment to the private software system of the company. Begin by identifying low-hanging fruits or little tasks that will yield immediate results. Then, while these implementations are underway, identify projects that will need more effort but will provide more significant benefits.

Quality is the primary need in the realm of pharmaceutical manufacturing. Therefore, projects should be carefully chosen with the goal of improving not just efficiency but also the quality of the company. The goal is to provide value to all stakeholders, patients and investors rather than picking digitalization projects based on the length or complexity of the project.

Staying flexible while implementing a digital solution in pharma manufacturing is essential for success. Digital solutions are designed to improve quality and efficiency, but they must be able to adapt to changing regulatory needs. As new regulations and market conditions emerge, a digital solution needs to be able to adjust quickly. This can help ensure that the manufacturing process complies with industry standards and regulations.

Training a dedicated team with external experts in digital solutions can effectively address the human resources issue. This team can collaborate to comprehensively examine all stakeholders, address project expectations, and ensure a successful transition to a digital environment. The team will also train the next generation of experts inside the company.

These solutions should also be integrated into quality and manufacturing management strategies. So, changes can be made faster and more efficiently, and small improvements can be scaled up to larger, more comprehensive solutions as needed.

Conclusion

Quality assurance and control are vital to the successful manufacturing of any pharmaceutical product. Digital technology can play a critical role in successfully implementing quality assurance and quality control procedures. By using these technologies, businesses can take advantage of automation tools and data analysis techniques to reduce manual intervention, improve accuracy and reliability, and increase efficiency, as well as regulatory compliance. Digital technology also offers a unique opportunity to monitor processes in real time and make adjustments quickly to mitigate potential risks and prevent costly delays.

To achieve maximum benefit from digital technology, organizations need to have a clear view of their quality objectives, and a well-defined quality assurance and control plan. It’s also important that companies undertake regular reviews and analyses to assess the effectiveness of measures and make necessary improvements. Ultimately a well-designed quality assurance and control system that leverages digital technology can help any organization create higher-quality products and services, ensure patient safety, and gain a competitive advantage.

Change is an ever-evolving process that businesses must continually deal with to remain viable. Even though the Pharmaceutical Industry has been slow in implementing digital solutions, digitalization brings a variety of opportunities and challenges that must be managed carefully in order to take advantage of them. Anticipating and planning for these challenges is key for the future of the Pharmaceutical Industry. 

Join us on March 23rd to examine the latest trends in Quality Management Systems (QMS) and Document Management Systems (DMS) and how they can help companies streamline their operations, improve collaboration, and increase efficiency:

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