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Master Batch Records, also known as Master Production Records and Master Manufacturing Records, are version-controlled templates for your manufacturing process. Dietary supplement manufacturing facilities are required to create these documents and keep them on file, but what exactly is the FDA looking for in a Master Batch Record?

In addition to a list of instructions for manufacturing each unique product and batch size, the FDA is looking for:

  • A complete list of individual equipment and processing lines
  • Identification of all equipment and processing lines
  • Verification of cleaning and calibration activities
  • Lot numbers and other control information for components, packaging and labels
  • Sampling, inspection and results of testing activities
  • Control of issuance and labels
  • Quality control approval
  • Signatures

Learn more tips for compliant Master Batch Records by downloading our latest webinar.

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