Electronic Batch Record In Pharmaceutical And Its Benefits

admin    |    23-09-2018

Since beginning Pharmaceutical & Biotechnology industries have stringent or strict rule and regulation than other industries and day by day it become more strict as products which are manufactured in these industries are directly affect the people health.  Each regulatory authority wants more transparency and control from the drug manufacturer. These high level of compliance and control is necessary to sustain the business and uphold the safety of patient.

Authorities require a controlled batch document which is used to produce the product so that each information about product manufacturing can assess. Traditionally, most of the pharmaceutical / biotech industry are use paper based system / batch record to manufacture and pack the drug products where each and every critical step written and people write manually each and every activities.

We are living in the era of communication and technology where we use lots of application on mobile / tablet as well to track each and every activity and now understanding of people w.r.t. computer has been increase and in market there are lots of software to make the life easy and simple so why we are still using old technology; paper based batch record in the pharmaceutical/ biotech industries where a single mistake can be dangerous to the patient health.

As on date modern electronic batch record option are available in market which could be integrate with other system like SAP or other ERP system and with the help of these electronic batch record complete information from end to end of product manufacturing can be record and trace.

Outdated (manual batch records) technology and its risk

With manual or paper based batch record chances of error is more as nowadays to comply the regulatory & quality requirement length of batch record are increasing day by day which make the process so complex and due to this complex process and lengthy batch record people makes mistake during writing critical information or transcription of data on the paper based batch record which is an audit-able document.

With this huge paper based batch record , manufacturing team are always under tremendous pressure to track manufacturing batch record generation, its review, filling and approval along with all usage equipment log book checks, environment monitoring log books checks and final batch release step. With this complexity relaying on manual system or hybrid system (where partially electronic mechanism are used i.e. SAP or other ERP system to create process batch order, dispensing order, release of batch & analytical results recording). Using of paper based / hybrid system are time consuming and situation become worst when frequent change over required, changing of employee are more who required more training to understand complete process.

With this manual process and data recording if any critical step missed or any mistake happened so in that situation if any deviation happened and suppose to be detected, log and investigated on time, may be detected too late during final review by another person which impact the batch release process.

Now you can understand in that complex situation how electronic batch record (eBR) can make a difference and make the life easy of pharmaceutical professional.

Electronic batch record (eBR) and its benefit

By using the electronic batch record , mistake can be minimize and electronic batch recipe can be used instead of manual recipe which reduce the error of missing any critical step. Other then this there are many other benefits of using electronic batch record in pharmaceutical/ healthcare/ biotech industries:

  • Reduce data entry time by 40% to 60%
  • Release time increase
  • Manual error eliminate and regulatory compliance increase
  • Automatic alert for any discrepancy. It can be received through mail/ sms
  • Deviation can be detected online without any delay
  • Breach of any data integrity can be avoided with entry of real time data
  • Each activity and progress can be track online
  • Online report of the process can be generate.
  • Regulatory compliance increase with real time data entry, electronic signature and full of traceability 

Before using these electronic batch record (eBR) its complete validation as per GAMP 5 and other standard is required.

To read the complete details of these electronic batch record (eBR) you can refer following source:

To read the complete details of these electronic batch record (eBR) you can refer following source:

https://www.lzlifescience.com/solutions/ebr/

http://3dsbiovia.com/products/unified-lab-management/biovia-ebr/

http://www.qumas.com/industries/pharmaceutical-biotech/quality-assurance-manufacturing/electronic-batch-records

 



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