A white Paper on the adaption of eBMR and MES in the Pharmaceutical Industry

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:marketing@baseinformation.com