Infographic: Powering cGMP for Cell and Gene Therapies
Quality. Compliance. Success.
In the rapidly evolving world of cell and gene therapy manufacturing, maintaining current good manufacturing practice (cGMP) compliance isn't just a regulatory requirement—it's the foundation of patient safety and product success. CGT manufacturers face unique challenges that demand specialized approaches to GMP standards, from managing complex raw materials to ensuring batch consistency across variable donor sources.
This comprehensive infographic, developed in partnership with Cell & Gene Therapy Review, reveals how cell and gene therapy manufacturers are overcoming critical hurdles to achieve GMP compliance through digital transformation. Discover proven strategies to streamline operations, reduce contamination risks, and accelerate product release while maintaining the highest quality standards.
Download this essential resource to understand how connected manufacturing systems are revolutionizing cGMP compliance for CGT manufacturers.
- Understand the critical cGMP challenges facing CGT manufacturers, from raw material qualification to batch variability management.
- Discover how automation and digital connectivity enable CGT manufacturers to maintain GMP standards while meeting demanding patient timelines.
- Learn specific strategies for achieving GMP compliance through electronic batch records (EBR), real-time monitoring, and automated equipment management.
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Transform CGT Manufacturing Through Digitization
Cell and gene therapy manufacturing demands precision, speed, and unwavering GMP compliance. Traditional manual processes introduce contamination risks and inconsistencies that can derail clinical trials and commercialization efforts. Digital manufacturing solutions offer CGT manufacturers a powerful path forward, enabling electronic batch records, real-time production monitoring, and automated compliance verification. By connecting quality and manufacturing operations through integrated software systems, companies can achieve 75%-80% faster GMP record review, reduce human error, and ensure every product meets rigorous quality standards while serving patients who can't wait.
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Unlock proven strategies for achieving cGMP compliance in CGT manufacturing.
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Infographic FAQs on cGMP for CGT Manufacturing
What key compliance hurdles for CGT manufacturing does the infographic identify?
The infographic highlights several specific challenges unique to cell and gene therapies. Explore the visual to discover the precise hurdles that might be affecting your CGT operations.
How many ways does the infographic outline for connected systems to improve cGMP compliance?
Our data-driven visual breaks down multiple specific approaches for using digital connectivity to enhance compliance. View the infographic to see the complete framework.
Does the infographic explain the connection between batch variability and digital solutions?
Yes! It illustrates the relationship between inherent batch-to-batch discrepancies in CGT production and how connected systems address these challenges.
What equipment management capabilities does the infographic suggest are essential for CGT compliance?
The visual outlines multiple specific approaches to equipment management that support cGMP compliance. Check the infographic to ensure your systems cover all these critical functions.
Why CGT Leaders Choose MasterControl
MasterControl's Manufacturing Excellence and Quality Excellence solutions provide cell and gene therapy manufacturers with integrated, digital-first platforms designed specifically for the unique demands of cGMP compliance. Our connected systems streamline operations, reduce risk, and accelerate your path from development to commercialization.
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Electronic Records
Digitize batch documentation and quality records to eliminate paper-based errors, ensure real-time data capture, and enable automated compliance tracking throughout your entire cell and gene therapy manufacturing process.
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Training Automation
Verify personnel qualifications automatically with integrated training management that ensures only properly trained, authorized staff access critical manufacturing and batch records, maintaining strict GMP compliance.
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Equipment Excellence
Streamline calibration and maintenance workflows with automated scheduling and documentation, minimizing downtime, preventing bottlenecks, and ensuring all manufacturing equipment consistently meets GMP standards.
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Accelerated Release
Achieve 75%-80% faster GMP record review and product release through intelligent automation, real-time monitoring, and connected quality systems that get life-saving therapies to patients faster.
