This document discusses electronic batch record management systems in the pharmaceutical industry. It explains that electronic batch record (EBR) systems allow pharmaceutical companies to digitize their production batch records for increased efficiency compared to traditional paper-based systems. The document outlines the benefits of EBR systems, such as reduced cycle times and improved accuracy, but also notes challenges in selecting and implementing a suitable EBR software solution.

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.

7. Companies providing EBR software
system