Originally Published on: QuantzigHow we Helped Pharmaceutical Manufacturer Reduce Rejection Rate and Rationalize Manufacturing Practice Using Sensor Data

Amplifying Operational Efficiency Through Analytical Mastery

Client's Profile: A preeminent UK-based pharmaceutical powerhouse, commanding a market capitalization exceeding $1 billion.

Overcoming Challenges: Our client grappled with persistent obstacles, chiefly high rejection rates and the imperative to streamline manufacturing practices. The recurrent rejection of product batches, attributed to deviations in critical quality attributes, not only incurred substantial financial losses but also disrupted product availability.

Innovative Tactics Deployed: Quantzig collaborated intimately with the client, harnessing the potential of sensor data to unravel the root causes of deviations and optimize manufacturing processes. Through avant-garde analytics and the establishment of a unified sensor data infrastructure, we achieved an impressive 80% reduction in rejection rates. This initiative not only provided near real-time insights into the design space but also laid the groundwork for improved future planning, ensuring sustained operational excellence.

Unleashing Impact: The implemented strategies bore noteworthy fruits:

• A substantial 80% reduction in rejection rates, emblematic of a significant enhancement in product quality.
• Real-time insights into the design space, empowering the client with proactive decision-making capabilities.
• Augmented foresight for refined future planning, contributing to sustained operational excellence.

Industry Dynamics: Within the UK's pharmaceutical manufacturing sector, where our client holds a pivotal position, activities encompass research, development, manufacturing, and distribution of pharmaceutical products. The optimization of manufacturing processes emerges as a linchpin, fostering streamlined operations, heightened productivity, and unwavering product quality.

Client's Conundrum: Our esteemed client grappled with the formidable challenge of consistent rejection of product batches by regulatory agencies due to deviations in critical quality attributes. This not only translated into substantial financial losses, surpassing $300K in product costs but also hindered the timely availability of products, impacting market responsiveness.

Addressing Challenges: Post-confirming that material quality aligned with defined standards, the client sought to identify the root causes of deviations in critical quality attributes. Despite meticulous testing, they discerned that deviations were not attributable to raw materials. Turning to sensor data for insights, they encountered the challenge of managing the immense daily data volume across multiple machines.

Tailored Solutions Delivered: Quantzig played a pivotal role in propelling manufacturing optimization by establishing an infrastructure to aggregate data from various sensors. This centralized hub efficiently collected and integrated data streams from multiple sensors, providing comprehensive visibility into operations.

Identification of crucial KPIs occurred through collaboration with subject matter experts, leading to the development of a system generating metrics from the vast data available. Leveraging correlation analytics, we not only identified existing KPIs but also discovered new indicators for more efficient tracking.

A robust framework was crafted to identify the root cause of deviations, utilizing patterns, anomalies, and potential correlations within the data. Systematic analysis of factors like process parameters and equipment performance pinpointed the precise root cause.

Continuous monitoring mechanisms, in real-time against defined SLAs, enabled swift detection of deviations, facilitating immediate corrective actions.

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