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Manufacturing

Manufacturing

Master Batch Lot History Record

Master Batch Lot History Records

Terms and Requirements Surrounding Master Batch Lot History Records

Manufactuers that comply with FDA regulations and cGMP requirements must keep master batch records, which are also referred to as:

  • Master production records.

  • Master manufacturing records.

  • Batch production records.

Understand common terms associated with batch records. Know how they fit together. 

MasterControl Electronic Batch Records™ (EBR)
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Understand batch records and batch release.

01

What is a batch record?

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Batch production records document the completion of every step in the production process. Traditionally collected in paper format, electronic batch records (EBRs) are becoming the new standard. The manual assessment of the paper-based production records is a cumbersome process prone to errors that can result in product quality issues, recalls, warning letters, or even consent decrees. 

02

What are electronic batch records?

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An electronic batch record (EBR) is a digital batch or production record that eliminates common pain points associated with paper-based batch records. EBR has the familiar look of paper and helps eliminate data entry errors that cause significant delays in time to market.

03

What is a batch release?

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A batch release occurs after production record documentation has been reviewed and approved as meeting regulatory requirements. Only after batch or lot release can a manufactured product be shipped to the customer or the public.

04

What is batch release in pharma?

A batch release occurs after production record documentation has been reviewed and approved as meeting regulatory requirements, allowing the product to be shipped to the customer or the public. In pharma, the quality control unit is charged with reviewing and approving all drug product production and control records, including those for packaging and labeling.

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Master Batch Records and Batch Production Records

Master Batch Records: Written instructions for a specific manufacturing process. These are required for each unique formulation and batch size. 

Batch Production Records: An accurate reproduction of the master batch record. These are used to document information about the production and control of each drug product batch. 

Both must include information specified in FDA 21 CFR 211.

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Device Master Record, Device History Record and Lot History Record

Device Master Record: A summary of all instructions and specifications from production of a product from start to finish.

Device History Record: All records from the manufacture of a particular finished product. 

Lot History Record:  Documentation related to a certain product lot. The lot history record authorizes and controls the production of a single lot of components or finished devices.

Increase speed to market.

Faster review times are just one benefit of electronic batch records.

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