Manufacturing
Manufacturers 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.
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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.
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.
