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
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