Applying Pharma 4.0 and GMP to Manufacturing Processes

Accelerate therapeutics innovation  and improve production processes in the pharmaceutical product lifecycle.

Pharma 4.0TM is a derivative of Industry 4.0, a German initiative to promote digital transformation in manufacturing. Where “smart factory” is often associated with Industry 4.0, “smart manufacturing” is often associated with Pharma 4.0.

A phrase coined by the International Society for Pharmaceutical Engineering (ISPE), Pharma 4.0 helps companies adopt digital technologies while adhering to global pharmaceutical regulations.

The ISPE is developing a roadmap to help the pharma industry with this transformation. Their mission is to realize the full potential of digitalization for faster innovations and for the benefit of patients.

The potential lies in advanced technologies like artificial intelligence (AI), machine learning, natural language processing (NLP), and automation. Pharma 4.0 incorporates the Internet of Things (IoT), augmented reality (AR), and cloud-based manufacturing execution systems (MES).

It also supports connectivity, data integrity, and digital quality.

Optimizing Digital Technologies for Transformative Outcomes

In the Integrated GxP Compliance on-demand webinar, presenter Haresh Patel, Vice President of Life Sciences Technology Solutions at USDM, talked about compliance and fast-tracking digital transformation. He specifically mentioned implementing digital technologies and digitalizing the validation process.

For companies that want to get an end-to-end view of the process, employ automation for processes and testing, and save significant time and effort, ProcessX is the ideal solution. Built on the ServiceNow platform, it enables your organization to tailor IT service management (ITSM) workflows and fine-tune them to your needs.

Digitalizing versus “Going Paperless”

Paperless validation systems have been a part of the pharmaceutical industry for years. While using less paper—or better, going paperless—is an admirable goal for companies big and small, digital transformation should be the primary focus.

Digitalization means using digital technologies for business processes. Automating manual processes to improve productivity is one example of digitalization. The benefits of digital solutions include:

• Efficiency and productivity. Reducing or eliminating manual data entry and getting approvals faster helps to shorten lead times and accelerate workflows. 
• Quality control. Facilitating real-time process monitoring and analyzing data helps life sciences organizations identify and prevent potential issues. 
• Data accuracy and traceability. Automating data capture reduces the risk of human error. Tracing every step of the manufacturing process helps to identify the root cause of a quality issue and quickly find a resolution. 
• Collaboration and communication. Providing a centralized platform to share information with various stakeholders enables faster decision-making, reduces lead times, and expedites time to market.  
• Regulatory compliance. Automating workflows, electronic signatures, and audit trails ensures that GxP activities are documented and recorded accurately. It also eases the burden of preparing for regulatory inspections. 
• Cost savings. Reducing or eliminating paper-based documentation cuts expenses related to printing, storage, and distribution. Streamlining processes improves productivity, optimizes your resources, and decreases operational costs.

Making Smart Decisions with the Help of AI and Machine Learning

Together, AI and machine learning algorithms are able to analyze large data sets and predict potential quality issues before they escalate. Throughout the quality process, predictive quality analytics use information retrieved from IoT tools like sensors and machine data to identify quality issues and prevent product loss or recalls.

With these tools and information, your organization is able to: 

• Perform root-cause analysis quickly and accurately 
• Save time by automating quality control processes 
• Minimize the risk of re-runs, batch loss, and recalls

Using AI and Automation for Transformative Change

In the bigger picture, AI and automation give employers and employees the opportunity to rethink how they work. As on-the-job skillsets evolve with these advances, the potential for transformation is huge.

For example, by using ProcessX and USDM Cloud Assurance to automate your Good Manufacturing Practice (GMP) processes, you’re able to assess risk, enforce system policies, and document any changes to the system because compliance and automation are built in.

Cloud Assurance unburdens your organization of initial validation and ongoing compliance maintenance. No matter how frequently vendors release updates, changes, or patches, automated software testing helps ensure that your regulated systems remain compliant.

To help your organization choose the right technology for your processes and workflows, USDM qualifies vendors that meet the quality and compliance demands of the life sciences industry. Learn about the Cloud Assurance Certified program and why it’s the badge of trust for GxP functionality.

Putting the Focus on Digital Quality

As the life sciences industry undergoes digital transformation, there’s a significant emphasis on digital quality to ensure that data is accurate, consistent, and retrievable throughout its lifecycle.

The USDM Integrated GxP Compliance managed service supports the transition from traditional paper-based quality to digital quality. Systems and vendors are audited to ensure that they comply with data integrity standards, cybersecurity measures, privacy, and digital-specific regulations.

USDM has strategies and solutions to help your organization achieve digital quality, including: 

• GxP process automation. Stop “managing” your GxP applications by way of spreadsheets and emails. Automating these processes improves speed and efficiency. 
• AI governance and roadmap. Choose technologies that support your evolving use of AI and automation. 
• Validation automation. Decrease your validation time by applying best practices and test automation capabilities. 
• GxP managed services. Learn why integrated GxP compliance is a catalyst to innovation and continuous improvement.

Simplifying Your Regulated Workflows and Processes

As a GxP process automation platform, ProcessX simplifies regulated workflows and processes, gives you greater insight for enterprise-wide business decisions, improves product quality and patient safety, and ensures that you maintain compliance.

ProcessX automates IT GxP workflows with clicks, not coding: 

• Regulatory Applicability Assessment 
• Periodic Review 
• GxP Incident 
• Cybersecurity Incident 
• User Access 
• Change Management

Manufacturing workflows include: 

• Cleaning Logs 
• Batch Record Review 
• Paperless Manufacturing

Gain valuable insights from your GxP technology and processes faster—and with scalability. ProcessX delivers an intelligent GxP process automation application with compliance built in.

Improve your production processes and accelerate innovation in your organization. Contact us to get started.

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