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EBR management in the pharmaceutical industry
1. Electronic Batch Record
Management in the pharmaceutical
industry
By: Pritam Singh
MBA-PM06
IIHMR,JAIPUR
2. Electronic Batch Recording System
Every phase of research & development, manufacturing, quality control and
product distribution must be thoroughly documented and reviewed at every
phase.
Maintenance of these records is vital to the day-to–day operation of every
pharmaceutical company manufacturing or marketing drugs and is necessary
for establishing a detailed audit trial for every lot of product manufactured.
Pharmaceutical companies have traditionally used paper (hard copy) to
maintain production batch records (PBR).
Also known as master production batch records (MPBR).
Many companies are realizing that the burden of paperwork can be lessened
with the use of computer system designed to manage this information.
3. Electronic Batch Recording System
In 1997 the FDA began to accept electronic batch records systems. Since then,
more and more manufacturers have recognized the advantages of automating
the process of controlling batch records.
Electronic Batch Record is designed for comprehensive data collection,
operator work instruction execution and electronic batch record reporting.
EBR displays batch records and manufacturing work instructions online,
providing the advantage of paperless data recording.
4. Continued..
A successful implementation of an EBR system can be challenging.
If not applied effectively it actually increase the burden of compiling batch
records.
EBR software system is available in wide Variety so it is very much difficult to
select suitable one.
5. Benefits of EBR system
Reduced cycle times
Improved accuracy & consistency of batch record.
Cost avoidance
Increased speed of product changes and product introductions.
Electronic batch record helps to improve productivity
Helps to identify wrong material, expiry material
Online documentation of process steps.
Reduction of administrative work for maintaining manufacturing documents.
Reducing the number of lost batches.
6. Challenges
All the companies realized that paper work are lessened with use of EBR
system so they are moving for paperless manufacturing environment.
FDA also forcing companies to switch completely into electronic based
system.
Before implementing EBR system it is important to understand the capabilities
of the supporting system.
It is important that manufacturers develop a strategic plan for their
implementation and validation
This plan should include the objective of the system supported by a return-on-
investment analysis.
