CFR section
21 CFR 225.102(b)(1): 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(b)(1) |
|---|---|
| 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 | Drugs, Veterinary |
| Regulation text (excerpt) | (1) A Master Record File shall be prepared, checked, dated, and signed or initialed by a qualified person and shall be retained for not less than 1 year after production of the last batch or production run of medicated feed to which it pertains. The Master Record File or card shall include at least the following: (i) The name of the medicated feed. (ii) The name and weight percentage or measure of each drug or drug combination and each nondrug ingredient to be used in manufacturing a stated… |
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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.