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Close This Window Growing Need of Manufacturing Execution Systems (MES) in the Pharma Industry
by: SamuelArthur on
Date: Wed, 2 Mar 2011 Time: 1:50 AM
A special report published in AutomationWorld.com, a renowned online resource on automation tools, talks about the struggle of Nutramax Laboratories Inc to meet the Good Manufacturing Practices (GMP) regulations. In the absence of proper automation tools to connect the plant with Enterprise Resource Planning (ERP), the company was unable to manage the inventory and execute batch records as per the FDA standards.
Considered as the most regulated manufacturing industry, pharmaceutical industry faces severe challenges. GMPs require adherence to strict regulatory standards that can guarantee high production values, improved quality, record-keeping and product validation. Good understanding of the industry processes, advanced risk management systems and automated manufacturing are at the core of the system to surmount these challenges.
The new generation challenges have added a new dimension to the definition of operational excellence. The concept of operational excellence is no more limited to imbibing best industry practices at the production level, such as lean methods or six sigma programs. Operational excellence includes adherence to a wide set of regulatory standards to ensure international quality output. This requires a shift towards fully IT-integrated MES (Manufacturing Execution Systems) to deliver the best results at cost-effective rates.
MES: A Thrust towards Better Production Processes
As a concept, MES aims to streamline the processes conducted manually by people working at a pharmaceutical plant in relation to R&D, order tracking, packaging and supply chain management. By integrating these processes through an automated system, MES tends to equip the managers with comprehensive data to help in proper recipe management and electronic batch processing recording.
In terms of process control, IT-integrated MES focuses on delivering the right information to the right people in the real-time scenario. A narrowed down approach to MES can help implement a zero-error system right from the collection of raw materials to the final delivery. An electronic batch process recording system supported by MES enables electronic documentation. This reduces the time required to create manual batches and eliminates the complexity of paperwork in terms of batch management.
By integrating MES and Enterprise Resource Planning (ERP) systems, pharmaceutical industries can greater control over production. Although integrating MES and ERP requires programming skills and customized software, it offers better plant automation and control over manufacturing at plants and intelligent resource planning.
Another feature of MES that helps in reducing errors at the batch tracking and electronic process recording is automatic error identification. This feature requires employees to take immediate actions to overcome the problem, thereby eliminating the probability of lags in the corrective and preventive action (CAPA) process.
Although the pharmaceutical industry can be tagged as a ‘laggard’ in the field of technology adoption, MES has a well deserving place in the segment. By automating manufacturing, process control, supply chain and regulatory compliance mechanisms, MES has wide implementation opportunities in the pharmaceutical industry. This system will help the industry achieve multi-faceted operational excellence at a cost-effective rate.
According to Siemens AG, the pharmaceutical industry will have growth path choices in the near future. They can choose between a flexible recipe management in a big manufacturing plant or a small plant with dedicated production lines. While both models will define growth in different phases, IT integration will remain an integral part of these models. Connecting ERP and MES will help pharmaceutical companies execute managed clinical trials, ensure flexible production and measure continuous development.
About the AuthorI’m an industry expert and a writer on MES, ERP, GMP and other topics which can help various automations like factory automation, dairy automation, plant automation etc to run smoothly. Websites like www.sarlatech.com are places to look for such industrial automation projects. Rating: Not yet rated Login to vote | Not Registered? Create an account Comments
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