CFR section
21 CFR 225.102(b)(2): 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)(2) |
|---|---|
| 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) | (2) The original production record or copy thereof shall be prepared by qualified personnel for each batch or run of medicated feed produced and shall be retained on the premises for not less than 1 year. The production record shall include at least the following: (i) Product identification, date of production, and a written endorsement in the form of a signature or initials by a responsible individual. (ii) The quantity and name of drug components used. (iii) The theoretical quantity of… |
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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.