Electronic Batch Manufacturing records and MES in Pharmaceutical
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The document discusses the adoption of electronic batch manufacturing records (eBMR) and manufacturing execution systems (MES) in the pharmaceutical industry. It notes that pharmaceutical companies are under pressure to minimize human errors and ensure regulatory compliance, driving adoption of technology solutions. While ERP systems tracked workflows and materials, they lacked control over manufacturing processes. eBMR and MES help address this by enabling equipment to communicate process parameters and measurements digitally in real-time rather than relying on manual recording. This increases accuracy, productivity and ensures compliance. The document provides an overview of Base E12 MES and eBMR software.
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Electronic Batch Manufacturing records and MES in Pharmaceutical
- 1. White Paper on eBMR and MES in the Pharmaceutical Industry
- 2. White paper on eBMR, MES and its adoption in Pharmaceutical Zero tolerance in quality and regulatory compliance has compelled the pharmaceutical industry to embrace technology at a faster rate than other players in the process industry. The industry is always trying to adapt solutions that will minimize human errors and ensure that procedures and practices are adhered to routinely. ERP systems ensured that the manufacturing process were followed as per the required procedure and practices ERP and manufacturing systems ensured that workflows were in place and traceability of materials and events. ERP and manufacturing software had little- to- no control on the manufacturing processes. Though the machine parameters were recorded in the software masters there was no way the software could ensure that the same parameters were implemented as mentioned in the masters Similarly measurement and feedback of various parameters in the manufacturing process like time, temperature, humidity, cycle counts etc were manually observed and recorded providing a window for error and impacting the process leading to a quality failure. In most organizations The ERP systems were unable to “talk” to the machines and ensure that they were set to the required parameters or the information mentioned in the batch manufacturing records was as reported at the give time by the machine or the instruments on the manual batch records. There remained a gap between the machines and the ERP / manufacturing software’s. A human intervention was required to set machine parameters and record the various parameters in the batch manufacturing records manually. Global Pharma players realized the need for timely and accurate manufacturing information that can be collected, stored, retrieved, analyzed and reported more readily. Slow takeoff of MES and eBMR One of the main reasons for the slow takeoff of MES in the pharmaceutical industry has been lack of equipment equipped with PLC designed to capture and provide data.
- 3. use “Standards” for automation as there was no compelling need to share data with any other equipment or software systems. Interfacing legacy equipment to an ERP was a very expensive and effort as PLC manufactures did not speak one common language or standards. There were more than protocols and interfaces had to be developed for each of the protocols . In the recent years most of the equipment and Plc manufactures have embraced the OPC standards, making it easier for equipment manufacturers and software developers to interface with equipment seamlessly. What is eBMR? Electronic Batch Manufacturing Record is an efficient way to capture data, exchange batch information, batch production management, maintain data security and integrity, and report production. It facilitates on-line control, batch processing, and provides operator guidance through SOP’s and signature authorization of the process. While eBMR increases productivity and accuracy of operators, features such as security, audit log generation, and e-Signature capture, ensures compliance to cGMP requirements, such as FDA 21 CFR part 11 eBMR enables reviews by exception. Ensuring that data beyond the acceptance limit are reviewed. It provides complete and accurate documentation and minimizes human errors through automatic verification of data. It provides a view of production history received from the manufacturing control system layer, and the interactive review process from quality assurance to manufacturing paves the way for operational efficiency. eBMR is configured to meet the individual needs of each organization. Data capture forms, workflows, routings, notifications escalations are created based on the unique need of the customer. MES and e BMR ensures The right material has been used. The materials have been weighed as per the recipe. SOPs and checklist have been followed for machine preparation. Ensure sequencing of operations as per SOPs. In process parameters are monitored and recorded at stipulated intervals.
- 4. eBMR and MES have gone beyond the “paper on glass” approach . eBMR SOP ,forms,etc and a historian of batch data. Overview of Base E12 MES and eBMR To know how more please contact Base Information Management Pvt Ltd. Contact 715-718, D-Wing, 7th Floor, Neelkanth Business Park, Nathani Road, Vidyavihar (West),Mumbai – 400086, INDIA www.baseinformation.com Tel +91-22-25106673 Email:[email protected]