CFR section
21 CFR 225.102(a): Master record file and production records
PART 225-CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS · Subpart E-Records and Reports
Key facts
| Citation | 21 CFR 225.102(a) |
|---|---|
| Section | Master record file and production records |
| Part | PART 225-CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS |
| Subpart | Subpart E-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Devices, Drugs, Veterinary |
| Regulation text (excerpt) | (a) The Master Record File provides the complete procedure for manufacturing a specific product, setting forth the formulation, theoretical yield, manufacturing procedures, assay requirements, and labeling of batches or production runs. The production record(s) includes the complete history of a batch or production run. This record includes the amounts of drugs used, the amount of medicated feed manufactured, and provides a check for the daily inventory record of drug components. |
At a glance
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.