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INSIGHT# 2010-38EMH AUGUST 19, 2010

ARC's Eighth India Forum: Enabling Technologies for Pharmaceutical, Food, and Beverage Industries
By Rajabahadur V. Arcot and Piyush Dewangan

Keywords
ARC Forum, Enabling Technologies, Food, and Beverage, Manufacturing IT, Pharmaceutical, Process Analytical Technology, Quality by Design

Overview
ARC Advisory Group’s eighth India forum included a separate track focusing on automation, enterprise, and collaborative production management solutions for the pharmaceutical and food & beverage industries. Shyam Bang, Executive Director, Jubilant Organosys, chaired the pharmaceutical and food & beverage track, with Rajabahadur Arcot, ARC Advisory Group, acting as the co-chairperson. The forum speakers in the pharmaceutical and food & beverage track emphasized the various challenges faced and the technological solutions that address them. The technology solution providers, such as Siemens, ABB, Cognizant, B&R Automation, Invensys Operations Management, Rockwell Automation, and SAP, and speakers from Dr. Reddy’s Laboratories and Aveta Lifesciences presented their views and experiences about achieving compliance, electronic batch record (EBR) systems, manufacturing execution system (MES), plant safety systems, process analytical technology (PAT), and quality by design (QbD), and others.

Both pharmaceutical and software industries have performed well within their spheres in India and could work together synergistically to create more value and for their mutual benefit.

Pharmaceutical Companies Need Manufacturing IT Solutions for Achieving Excellence
The session Chairman, Shyam Bang, in his keynote address spoke about India’s pharmaceutical industry challenges in the context of its potential and promise. Both pharmaceutical and software industries have performed well within their spheres in India and could work together synergistically

VISION, EXPERIENCE, ANSWERS FOR INDUSTRY

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to create more value and for their mutual benefit. Speaking about the technological challenges, Mr. Bang listed various issues that confront the industry. These include frequent technological changes, software upgrades, version changes, integration issues, and lack of process domain knowledge among the suppliers. While India’s pharmaceutical companies are beginning to realize the need to invest in technology solutions for achieving excellence, selecting and implementing appropriate solutions remains a major challenge.

Invest in PAT and QbD
Process analytical technology (PAT) and quality by design (QbD) are key pharmaceutical industry manufacturing initiatives for converging business objectives, lifecycle excellence, and regulatory compliance. Siemens and
PAT enables early process understanding, reduces rework, inventory, and operational costs, optimizes operations, and reduces time to market for new products.

ABB, represented by Abhijit Tambat and Mark Zugelder respectively, spoke about PAT and QbD benefits. Abhijit Tambat, in his presentation, urged

pharmaceutical companies to deploy PAT solutions to ensure that a product is manufactured “first time right,” resulting in reduced rework, scrap, and inventory and enhanced equipment utilization. PAT helps improve the process, achieving optimization and process validation and reducing both time to market and cost of quality. Mr. Tambat also spoke about increasing global concerns about counterfeit medicines. He advocated adoption of mass serialization and e-pedigree to overcome this challenge effectively. While mass serialization assigns Tracking and unique identification numbers to each package, case, or pallet; e-pedigree can capture drug pedigree data in electronic format. traceability solutions aid in tackling counterfeit medicines. Mark Zugelder shared his thoughts about PAT and QbD. He said that a better understanding of the processes, achieved through PAT, facilitates flexible production plus reduced operational costs and time to market. He went on to suggest that pharmaceutical companies must shift from traditional quality assurance through inspection/control, to a QbD approach. He emphasized that PAT and QbD principles can be applied across all types of pharmaceutical manufacturing processes.

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Achieving Operational Excellence
Automation and Electronic Batch Recording Systems

Senthil Kumar, Invensys Operations Management, spoke about the appropriate automation systems for the life sciences industry and the business drivers, such as regulatory compliance, that spur the pharmaceutical companies to invest in these. Increasing awareness among manufacturing companies that cost reduction is best achieved through deployment of advanced process control systems and that electronic records ensure compliance with 21 CFR PART 11 requirements further hasten technology adoption. Chinmoy Roy, Aveta Lifesciences, spoke about the benefits of review by exception through electronic batch record (EBR) systems. Here, only exception data falling outside the acceptable limit requires operator review. Mr. Roy spoke about online review tools (OLRT) that facilitate review by exception and their interface with the manufacturing control systems. The integration of control systems with OLRT will significantly reduce the batch release time and improve the flexibility in work process flows. K.V. Rajan, of ABB provided an insight into batch management and facility automation solutions for overcoming several operational challenges faced by pharmaceutical companies. These include consistency of product His specifications, traceability, and improving equipment utilization.

recommendations to pharmaceutical companies interested in automated documentation, electronic batch records, and such others are that they should invest in batch management and facility automation solutions to seek operational excellence.
Collaborative Production Management

A.V. Rao, from ITC together with Shivam Mittal of SAP, presented a case study on manufacturing excellence in the batch industries. discussed achieving manufacturing transformation by Mr. Mittal integrating

production planning, asset management, and execution
ITC achieved manufacturing transformation by integrating planning and scheduling with asset management and execution operations.

functions.

Mr. Rao spoke about how ITC achieved

manufacturing transformation by integrating planning and scheduling with asset management and execution operations. ITC implemented automation systems, such as DCS and PLC at the plant level, and

manufacturing execution systems at the operations management level and

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integrated them with the enterprise resource planning solutions at the business level, incorporating supply chain intelligence.
Reducing operating cost is the key business driver spurring companies to seek continuous improvements or operational excellence. OpX is achieved through production planning and control, manufacturing execution, and operating effectiveness.

Mayuresh Unde, Cognizant Technology Solutions, spoke about operational excellence as the systematic pursuit of world-class performance in productivity, quality, and delivery of services and/or goods. Reducing operating cost is the key business driver spurring companies to seek continuous improvements or operational excellence. production planning and OpX is achieved through control, manufacturing

execution, and operating effectiveness. operational excellence.
Power Management Systems

These are the three pillars of

After a brief introduction by Rajesh Vedak of Rockwell Automation, Sanjay Mantri, Dr. Reddy’s Laboratories, spoke about the benefits that his company derived from implementing power management SCADA (PMS). Apart from ensuring reliable and uninterrupted power for the plant, PMS also helps in demand side management. PMS also helps in improving plant performance metrics and reducing operational expenses. and quality. In the pharmaceutical industry, uninterrupted operations lead to improved yields

Technology Trends: openSAFETY Protocol and Systems
Uwe Keiter, B&R Automation spoke about the openSAFETY protocol, which after testing according to IEC 61784-3 FSCP 13, was approved and released for international standardization. openSAFETY can be used with all fieldbus and Ethernet systems and is certified by TÜV for SIL 3 applications. Open systems provide end users with flexibility and freedom of choice.

Last Word
India’s pharmaceutical industry has emerged as a leading player in the generic drug market. Its achievements are largely due to its success in drug production through innovative processes and by putting in place work processes that ensure quality and compliance. With numerous pharmaceutical companies in India achieving global scale, it is time for the

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industry

to

leverage

technology

while

pursuing

global

growth

opportunities. collaboration,

Such investments in enabling technologies will help the and emerge best in class. Although technology

companies achieve operational excellence, foster internal and external implementation involves initial capital expenditure and subsequent operational expenses, the benefits are enormous. For further information or to provide feedback on this Insight, please contact your account manager or the authors at raja@arcweb.com and pdewangan@arcweb.com. ARC Insights are published and copyrighted by ARC Advisory Group. prior permission from ARC. The information is proprietary to ARC and no part of it may be reproduced without

©2010 • ARC • 3 Allied Drive • Dedham, MA 02026 USA • 781-471-1000 • ARCweb.com