Batch Number/ Lot Number

Batch number or Lot number is an serial number or reference given to the record of manufacturing process of a specific quantity of formulation manufactured in single manufacturing order during the same cycle of manufacture and printed at label of the formulation that allows the history of its production to be traced.
Standard Operating procedure of Batch Numbering:
  • There shall be Standard Operating Procedures describing the details of the batch (lot) numbering set up with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number.
  • Batch numbering Standard Operating Procedures applied to a processing stage and to the respective packaging stage shall be same or traceable to demonstrate that they belong to one homogenous mix.
  • Batch number allocation shall be immediately recorded in a logbook or by electronic data processing system.

Batch Number is a part of batch manufacturing record and manufacturing record maintains the following particulars:
  • Serial Number
  • Name of product
  • Master Formula Record Reference
  • Batch/Lot Size
  • Batch/Lot Number
  • Date of starting of manufacturing and completion of manufacturing
  • All ingredients list with quantity for particular lot/batch size
  • Different processed conducted during manufacturing process with time and date
  • Environmental Control details 
  • In process quality control processes
  • Analytical test reports 
  • Signature of competent technical staffs
  • Date of release of finished pharmaceutical products etc

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