CFR section
21 CFR 225.102(b)(3): 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)(3) |
|---|---|
| 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 |
| Regulation text (excerpt) | (3) In the case of a custom formula feed made to the specifications of a customer, the Master Record File and production records required by this section shall consist either of such records or of copies of the customer's purchase orders and the manufacturer's invoices bearing the information required by this section. When a custom order is received by telephone, the manufacturer shall prepare the required production records. |
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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.