The pharmaceutical industry generates sizable data during the entire manufacturing life cycle, mainly due to regulatory regulations, to ensure and prove the efficiency, safety, and reliability of the production process & product.
Among many critical documentation is the electronic batch record, which records the batch process and represents how production went during each stage of the production process.
Its advanced version is the Electronic Batch Record, which automates the traditional batch record and fills the loopholes of the conventional system.
What is an Electronic Batch Record?
Electronic Batch Record is a software system or a set of digital tools that automatically updates the batch record as the production progresses on the production floor. The electronic batch record takes input from several input variables across different process stages and is integrated into the software system.
The batch record updates itself every time there is progress and records in an electronic format & paperless manner.
In simple words, the electronic batch records can be considered an electronic version of the traditional paper batch, where each step has been modified to work in an automated manner. Additionally, it can integrate with other Software and transfer data between different software systems installed at different departments.
An electronic Batch record contains the history of the production process of a particular product with every minute detail. It includes information such as the raw material, equipment, manufacturing method, testing results, date and the personnel involved in the manufacturing process, much like the traditional batch record that aims to prove to regulatory bodies that it has followed every necessary GMP and other regulatory guidelines.
The traditional method of developing and maintaining batch records has been on paper, where personnel manually create and enter the required queries. For obvious reasons, it becomes difficult to maintain and retain these records, with endless storage requirements and dedicated resources to make them error-free.
Additionally, these resources are prone to human error that can affect the pharma manufacturer's approval during the regulatory review.
To address the errors above and alike, manufacturers are turning towards electronic batch records that automate the batch recording process.
Electronic Batch Record is the latest development of digital transformation or Pharma 4.0, which is rapidly getting traction. It allows pharma manufacturers to align their product manufacturing process with other digital solutions, such as laboratory automation and warehouse management systems, to increase safety, quality and productivity within a pharm organization.
Electronic Batch Record Architecture
Like other software systems, the electronic batch record consists of an architecture that defines the overall functioning and essential components. Please note that the names can differ from developer to developer, but their overall function and purpose remain the same.
Let's briefly describe these.
Recipe Management
The electronic batch record system allows personnel to create predefined formulations or recipes previously tested, approved and followed during the product manufacturing process.
Its main advantage is that it guides throughout the manufacturing process and ensures accurate and correct ingredients have been used and the process is free from deviations. It also helps to trace the manufacturing process during product failure or recall by pinpointing the cause and its stage.
This safety feature (which we will discuss later) prevents unauthorized persons from creating, editing, and deleting recipes and limits them only to authorized persons.
Production records
The Electronic Batch Record measures and records every process conducted during manufacturing, with the help of different input variables, in an automated manner without human involvement.
The best part is that the record cannot be altered, as with the manual records. It enables production personnel to assess errors or shortcomings if the product becomes erratic or recalled.
This feature is an integral ...
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