Basic Concepts of Track And Trace System For Pharmaceutical Industry

DETAILS : 

• Author : Rameshwar Verma
  
• Publisher ‏ : ‎ Orangebooks Publication
  
• Publication date ‏ : ‎ 16 September 2021
  
• Edition ‏ : ‎ First Edition
  
• Language ‏ : ‎ English
  
• Paperback ‏ : ‎ 190 pages
  
• ISBN-10 ‏ : ‎ 9390837375
  
• ISBN-13 ‏ : ‎ 978-9390837373
  
• Item Weight ‏ : ‎ 250  g

ABOUT THE BOOK

Basic Concepts of Track and Trace System for Pharmaceutical Industry is an essential technical guide addressing one of the most critical challenges in global healthcare: the security and integrity of the medicine supply chain. As counterfeit drugs become an increasing global threat, this book serves as a roadmap for implementing robust serialization and tracking systems.

The book provides a comprehensive breakdown of:

• Serialization Essentials: Understanding unique identifiers, 2D data matrices, and the hardware required for high-speed printing on packaging lines.
• Regulatory Landscapes: A detailed look at global mandates such as the DSCSA (USA), FMD (EU), and DGFT requirements (India).
• Aggregation: The process of building parent-child relationships between individual units, cartons, and pallets to ensure end-to-end visibility.
• Data Management: How to handle the massive influx of data (Level 1 to Level 5) and integrate it with ERP and cloud systems.
• Implementation Strategy: Practical advice on vendor selection, validation, and managing the "people and process" change within a manufacturing facility.

It is a vital resource for production managers, IT professionals in life sciences, and regulatory affairs specialists who need to navigate the complex intersection of technology and pharmaceutical compliance.

ABOUT THE AUTHOR

Rameshwar Verma is an industry expert with extensive experience in pharmaceutical manufacturing and supply chain technology. He is recognized for his ability to translate high-level regulatory requirements into actionable engineering and IT solutions.

Verma’s work is characterized by a practical, "boots-on-the-ground" perspective, focusing on the real-world hurdles companies face during the digital transformation of their packaging lines. Through his writing and professional contributions, he has become a key voice in helping the pharmaceutical industry adopt "Industry 4.0" standards to ensure patient safety and global compliance.