ISPE India Pharma 4.0 Conference

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Pharmaceutical companies are increasingly using automation and robotic solutions in processes such as drug development, manufacturing, and anti-counterfeiting.

 Final 21 Part 11 Regulations of the US FDA in 1997 paved the way for electronic records, electronic signatures and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures achieved on paper.   

 Analytical laboratories in Pharmaceutical Industry face many challenges. These include very complex workflows, meeting regulatory requirements including data integrity, reducing errors in respective tasks, and doing more with less resources both in terms of manpower and capital.  

 At a very high level IoT is used  to define objects that "talk" to each other. What it really means is that the Internet of Things is made up of devices from sensors to smartphones and wearables – connected together and by these connected devices when connected to automated systems, gathers information, analyses it and create an action in a particular task, or to learn from a process. 

 AI offers many possibilities in the pharmaceutical industry, including but not limited to optimizing process design and process control, smart monitoring and maintenance, and trend monitoring to drive continuous improvement.  

 The pharmaceutical industry utilizes empirical data to identify patterns, examine theories, and understand the quality of treatments. Therefore Big data analytics is a natural choice to process this enormous data. Big data holds great promise in improving all aspects of the pharmaceuticals like  research, drug development and clinical trials. 

 Blockchain technology is a distributed ledger that enables the efficient, permanent, and verifiable recording of transactions. It is also a decentralized database that can be used to manage an ever-growing list of records called nodes. 

 Electronic Batch Records (EBRs) are digital systems used throughout the manufacturing process to capture, store, and manage batch-related information. They serve as a comprehensive record of all activities, specifications, and procedures associated with a batch’s production.  

 Traditionally warehousing involves manual processes, human labour managing inventory and warehouse workers travelling across the warehouse to fulfil orders. However, the emergence of warehouse automation has revolutionized the storage and distribution processes, with improvement in efficiency. I 

 Implementation of Pharma 4.0 involves use of computers and therefore CSV becomes an important aspect. A Risk-Based Approach to Compliant GxP Computerized Systems aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.  

   The pharmaceutical industry hosts sensitive information like about patients, patented drugs, clinical trials, research projects, and advances in technology on computers making it a major target for cyber criminals. Further the increase in automation tools, and the use of third-party vendors pose major cyber-security challenges.