Digital and Intelligent System Compliance Application

Pharma 4.0 Intelligent Factory in the Pharmaceutical Industry

Pharma 4.0 intelligent factories in the pharmaceutical industry represent a holistic operational model for future pharmaceutical enterprises and supply chains. The goal is to enable organizations engaged in the drug lifecycle to fully utilize digital and intelligent technology innovations, ensuring drug safety, efficacy, and stability while prioritizing patient safety. Data integrity and efficient lean operations are crucial prerequisites for ensuring patient safety and product quality."

Client Need

Our client, a leading pharmaceutical company, initiated an intelligent manufacturing project to build a "Beacon Factory" – a digital, automated, and intelligent facility capable of manufacturing 10 billion tablets, complying with FDA cGMP.

Our Solutions

(1) Digital consulting, data-driven product design optimization

• Conducted digital product research and design optimization to streamline processes.

• Implemented material scanning for identification and information traceback.

• Utilized simulation calculations for production and material flow systems.

(2) Integrated Manufacturing Execution System (MES)

Integrated MES with material management system, WCS system, AGV scheduling system, and automatic weighing and dispensing system.

(3) ISPE GAMP5 compliant computerized system validation

AUSTAR Contribution and Customer Benefits

AUSTAR leverages global high-quality resources and cutting-edge pharmaceutical intelligent manufacturing technology to deliver tailored digital consulting services compliant with US FDA cGMP requirements. Our integrated solution seamlessly incorporated automation, information technology, and advanced process equipment to streamline operations. We also implemented rigorous computerized system validation to ensure compliance and operational integrity.

Customer Benefits

• Achieved intelligent manufacturing with minimized costs, superior quality, maximum efficiency, and unmanned, paperless production.

• Increased labor productivity by approximately 80%.

• Significantly reduced system energy consumption.

• Decreased production and operational costs by about 30%.

This case study highlights AUSTAR's commitment to enhancing pharmaceutical manufacturing through advanced digital and intelligent technologies, ensuring both operational excellence and regulatory compliance.