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Indian pharma steers towards real-time quality control with automation & IIoT for traceability & regulatory compliance
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Nandita Vijayasimha, Bengaluru
July 24 , 2025
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Indian pharma is implementing automation and the Industrial Internet of Things (IIoT) to ensure compliance and consistent product quality. By integrating IIoT sensors and automated systems across manufacturing processes, pharma companies achieve continuous, precise monitoring of environmental and operational parameters eliminating variability and protecting product integrity throughout production and distribution. There is also end-to-end traceability and regulatory precision.
This integration directly meets regulatory expectations while accelerating market readiness and reducing quality failures, positioning intelligent quality control as a foundational industry standard. The industry increasingly views real-time monitoring as a paradigm shift in quality assurance, stated Prashant Sinha, marketing head, WIKA India, a measurement instrumentation technology major.
Traditional pharmaceutical production depends on scheduled manual sampling and post-process testing, which delays the detection of deviations. Automation combined with IIoT replaces this model by embedding networked sensors within production and packaging systems. These sensors capture live data on variables such as temperature, humidity, pressure, and contamination, he added.
As data is captured and transmitted instantly, this visibility enables proactive interventions before product quality is compromised, significantly reducing batch rejections and recalls. Automated data capture also prevents manual error, maintaining validated records that align with Good Manufacturing Practice (GMP) and international compliance frameworks.
Pharmaceutical manufacturing requires verified records at every stage of production. IIoT- delivers this by logging precise timestamps, process data, and environmental conditions without manual intervention. Digital provide tamper-proof documentation that supports patient safety for regulatory submissions.
When an issue arises, it aids root cause analysis and also enables swift corrective actions and iterative process improvements. Integration with Manufacturing Execution Systems (MES) and ERP solutions creates unified data management and simplifies regulatory reporting, aligning operational and compliance functions. It improves efficiency and minimises operational disruption, Sinha tod Pharmabiz.
Automation and IIoT reduces manual dependency while maintaining consistency in sterile filling and packaging. It executes complex operations with precision, supports production continuity without compromising on quality thresholds, he said.
Sensors embedded in equipment also monitor real-time performance metrics, allowing predictive maintenance. This reduces downtime, maximises asset use, and controls service costs, maintains manufacturing agility. There is also supply chain visibility and cold chain management, he noted.
IIoT-driven cold chain monitoring actively maintains validated temperature ranges for sensitive pharmaceuticals across storage and transit, triggering real-time alerts for immediate corrective action. This infrastructure also enables live inventory tracking, allowing manufacturers to forecast demand accurately, reduce stock imbalances, and optimise logistics. By uniting environmental control with supply intelligence, IIoT protects product integrity while driving smarter, faster operational decisions, particularly crucial for high-value or time-sensitive therapies, he said.
With real-time data, these technologies enable smarter production, reduce compliance risks, and enhance product reliability. As regulatory expectations and operational complexity increase, pharma companies view IIoT-led automation not as an upgrade, but as a baseline standard for modern manufacturing. In fact, it represents the industry’s shift toward precision, speed, and system-driven quality, said Sinha.
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TOPICS
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