Real-Time Process Monitoring for Enhanced Quality and Efficiency  

At MedPharm, we harness the power of In-Line Analytics to deliver real-time monitoring, control, and optimization of topical and transdermal drug manufacturing processes. By integrating advanced analytical tools directly into our production workflows, we ensure continuous quality assurance, process efficiency, and regulatory compliance without the need for disruptive batch testing.  

Our state-of-the-art Process Analytical Technology (PAT) systems enable data-driven decision-making, reducing process variability while improving product consistency, yield, and alignment with regulatory standards.   

Benefits of In-Line Analytics in Pharmaceutical Manufacturing   

Real-Time Process Monitoring and Control  

• Continuous data collection for real-time assessment of critical process parameters (CPPs).  

• Automated adjustments to maintain batch consistency and product quality.  

• Reduction in production downtime by identifying process deviations early.  

• Optimization of efficiency by eliminating unnecessary batch hold-ups. 

🔹 [Learn More About Continuous Processing →]   

Improved Product Quality and Batch Consistency  

• Ensures reproducibility by detecting variations during manufacturing.  

• Automated precision monitoring of drug concentration, viscosity, and stability.  

• Minimizes the risk of batch failure, which reduces cost and material waste.  

• Supports advanced process control (APC) strategies.  

🔹 [Learn More About Our Quality Control and Testing →]   

Regulatory-Ready Process Optimization  

• Meets FDA, EMA, and ICH Quality by Design (QbD) and Process Analytical Technology (PAT) guidelines.  

• Provides regulatory-compliant real-time data for validation and process control.  

• Supports process validation for commercial scale-up and technology transfer.  

• Facilitates seamless documentation for NDA, ANDA, and BLA submissions.  

🔹 [Learn More About Our Regulatory and Compliance Support →]   

Advanced In-Line Analytical Technologies at MedPharm

• Near-Infrared Spectroscopy (NIR) and Raman Spectroscopy – Real-time monitoring of API concentration and content uniformity.  

• Focused Beam Reflectance Measurement (FBRM) – Optimizing particle size and monitoring crystallization.  

• ReactIR™ and Process Mass Spectrometry – Real-time reaction tracking and impurity detection.  

• Transepithelial Electrical Resistance (TEER) Testing – Evaluating barrier integrity in topical formulations.  

🔹 [Learn More About Our Analytical Capabilities →]   

Seamless Integration with MedPharm’s Continuous Manufacturing

• Eliminates batch-to-batch variability, ensuring process consistency.  

• Enables real-time adjustments during continuous flow production.  

• Improves efficiency and regulatory compliance for commercial manufacturing.  

🔹 [Learn More About Continuous Flow Technologies →]   

Why Choose MedPharm for In-Line Analytics?

✅ Industry-leading Process Analytical Technology (PAT) expertise.  

✅ Regulatory-compliant real-time quality control and process optimization.  

✅ Advanced data-driven manufacturing with continuous monitoring.  

✅ Seamless integration with scale-up and commercial production.  

✅ Higher yield, lower waste, and faster market readiness.   

Optimize Your Drug Manufacturing with MedPharm’s In-Line Analytics Expertise

MedPharm’s In-Line Analytics solutions provide real-time quality control, process optimization, and regulatory-compliant data, ensuring high efficiency, cost-effective, and scalable drug production.   

Contact us today to learn how our real-time process monitoring solutions can support your pharmaceutical development and manufacturing needs!