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

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

As on date modern electronic batch, record options are available in the market which could be integrated with another system like SAP or other ERP system, and with the help of these electronic batch records 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Outdated (manual batch records) technology and its risk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 a batch record are increasing day by day which makes 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 is 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 logbook checks, and final batch release step. With this complexity relying on a 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 is time-consuming and the situation becomes worst when the frequent change over required, changing of an employee are more who required more training to understand the 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, maybe detected too late during final review by another person which impacts the batch release process.

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

Electronic batch record (eBR) and its benefit

By using the electronic batch record, mistake can be minimized and the electronic batch recipe can be used instead of a manual recipe which reduce the error of missing any critical step. Other then this there are many other benefits of using the 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 the entry of real-time data
  • Each activity and progress can be tracked online
  • An online report of the process can be generated.
  • Regulatory compliance increase with real-time data entry, electronic signature and full of traceability

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

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

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