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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?

02

What are electronic batch records?

03

What is a batch release?

04

What is batch release in pharma?

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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.

Download the Free Product Data Sheet