CFR section
21 CFR 120.11(b): Verification and validation
PART 120-HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 120.11(b) |
|---|---|
| Section | Verification and validation |
| Part | PART 120-HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (b) Validation of the HACCP plan. Each processor shall validate that the HACCP plan is adequate to control food hazards that are reasonably likely to occur; this validation shall occur at least once within 12 months after implementation and at least annually thereafter or whenever any changes in the process occur that could affect the hazard analysis or alter the HACCP plan in any way. Such changes may include changes in the following: Raw materials or source of raw materials; product… |
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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.