Electronic Batch Record

Management in the pharmaceutical

industryBy: Pritam Singh

MBA-PM06

IIHMR,JAIPUR

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.

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.

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.

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.

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.

Companies providing EBR software

system