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)