Types of Batch Records

Batch records are crucial documents in various industries like pharmaceuticals, biotechnology, food and beverage, and chemicals, where they are used to ensure product quality and consistency. They provide a detailed account of the production process for a specific batch of product, helping to maintain compliance with industry regulations and standards. Types of batch records typically include:

1. Master Production Record (MPR) or Master Batch Record (MBR):
   This is a comprehensive document that outlines the standard method for manufacturing a product. It includes the formula, equipment, process instructions, packaging instructions, and quality control points. This serves as a template for producing individual batches and ensures that each batch is made consistently.

2. Batch Production Record (BPR) or Batch Manufacturing Record (BMR):
   This is created for each batch produced and is based on the Master Production Record. It documents the actual materials, equipment, and processes used, as well as any deviations from the MPR. It includes detailed information such as weights, measures, conditions, in-process checks, and signatures of the operators and quality control personnel.

3. Device History Record (DHR):
   In the medical device industry, the DHR is the equivalent of the BPR for medical devices. It compiles all the production history for a batch of devices and ensures that the device was manufactured according to the predetermined specifications.

4. Laboratory Control Records:
   These records include information on the testing conducted on the batch, such as raw material testing, in-process testing, and final product testing. They ensure that the product meets quality standards before it is released.

5. Packaging Batch Record:
   This documents all packaging operations. It includes information about the packaging materials, equipment used, and any in-process controls and inspections that are conducted during packaging.

6. Cleaning and Sanitation Records:
   These records document the cleaning and sanitizing of the equipment and facilities used in the production process. They are crucial in industries where cross-contamination must be strictly avoided.

7. Equipment Use Log:
   This log tracks the usage of equipment for each batch, including details of maintenance, cleaning, and calibration. It helps in tracing any potential source of product quality issues.

8. Environmental Monitoring Records:
   These records document the environmental conditions, such as temperature and humidity, during production. They are especially important in sensitive product manufacturing, such as pharmaceuticals.

9. Distribution Records:
   These records track where the batch was sent, which is critical for product recalls and traceability.

All these records are subject to regulatory review and must be maintained for a specified period, depending on the industry and applicable regulations. Records are vital for audits, investigations, and confirming that the product was manufactured according to Good Manufacturing Practices (GMP).