Glossary Definition: Batch Record (BR)

A batch record (BR) is the documented execution detail of the manufacturing process of a regulated product, including authors, steps, materials, and equipment.

Batch records are required for the manufacture of drugs and medical devices in life science manufacturing. This record includes the materials, equipment, steps, actions, data entries, people, processes, events and integrations that are necessary to successfully manufacture specific therapies and devices.

Batch records aim to successfully and accurately replicate the master batch record while also detailing any manufacturing differences. Batch manufacturing records (BMR) in the pharmaceutical industry aim to ensure drugs are produced safely and effectively, while also maintaining compliance.

Batch records are also referred to as:

• Batch formula records
• Batch manufacturing records
• Batch production records
• Batch Packaging Records
• Device History Records (DHR)

These terms all mean the same thing and are often used interchangeably. Medical Device manufacturers refer to batch records as Device History Records (DHR). And when digitized, they are often referred to as electronic batch records.

Batch records in pharma are documents that provide a detailed overview of the manufacturing process for a specific batch of drugs or medical devices. These records can be paper-based or electronic in nature, and aim to document every step taken to manufacture a product while maintaining safety, efficiency, and regulatory compliance. 

This thorough documentation allows pharma companies to ensure their therapies are manufactured accurately, and in accordance with the master batch record, regardless of who manufactures the drug or where it’s made.

Pharmaceutical batch records include information about the materials (such as the weight and count of the components), the product name, and a list of processes and procedures to follow.

A thorough batch record also contains:

• General manufacturing instructions (including health and safety)
• Equipment and cleaning requirements 
• List of all raw materials necessary and the quantities of each 
• Actual lot numbers and quantities of raw materials used
• The detailed execution of the manufacturing process
• Expected & actual yield of each batch, with reconciliation as needed
• Exceptions and deviations raised during manufacturing
• List of abbreviations and what they mean
• Revisions, changes, and associated dates

Batch records are important for pharma because they help to ensure that drugs are manufactured safely and efficiently every time.

Think of it like cooking — if you’re making a new dish for the first time, you’ll follow a recipe to ensure what you make meets your expectations. Similarly, in pharma, you’ll follow the master batch record to replicate a drug, and record every step along the way (in the event something goes wrong… so you can retrace your steps).

This component of the tech transfer process enables drug manufacturing to happen at scale, all while ensuring safety and efficiency. Plus, if any issues do arise later with a specific batch, detailed records are readily available for review.

Batch record management refers to the system that is used to manage batch records. This can be done manually or electronically. With manual batch records, information is collected and recorded on paper (or a paper-based system like Word). With electronic batch records, such as those offered in manufacturing execution systems (also known as MES solutions or MES software), data is captured digitally.

The benefits of using an electronic system for batch recording management include:

All in all, electronic batch records have proven to be more efficient and accurate than their traditional, paper-based counterparts.