BY: SADHISH JAINMBA PM-07ROLL NO.44

ELECTRONIC BATCH RECORD MANAGEMENT IN

PHARMACEUTICAL INDUSTRY

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.

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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.

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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. Reduction of administrative work for maintaining

manufacturing documents. Reducing the number of lost batches.

Strategic Option

Four TypesPaper System

Document Management Systems

Data Collection System

Manufacturing Execution System

[MES]

1.Paper system

It is the traditional method of maintaining the entire batch record on paper forms and computer printouts.

A Research estimates that 80-90% of pharmaceuticals are using this kind of system till now.

The movement of EBR has been slow.

2.Doc. Management System

The paper documents are created during the production process and they are scanned into system.

This can be performed at either intervals

throughout the production process, or when production is completed.

3.Data Collection System

This type of system captures batch record information during the production process.

Instead of paper the operators type the

information into a data capture device or transfer it from manufacturing equipment.

Data capture devices are : Desktop, PLC, PDA etc.

4.Manufacturing Execution System[MES]

Lacks the ability to capture all necessary data & summarize it in a format useful as a batch record.

It can be integrated with much of the equipment and system used in production.

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.

Conclusion

From Above the Case it is concluded that the burdens of paperwork are lessened with the use of EBR systems, which has many advantages for the pharmaceutical industry.

Most of the pharmaceuticals are moving to paperless manufacturing environments and are implementing a score of solution.

But still there are using of the traditional system.Although The FDA accepts hybrid Systems, industry

analysts expect that this will not for last long.As a result pressure may be placed on companies to

switch completely to EBR.

Companies Providing the EBR System