CFR section
21 CFR 117.160(b): Validation
PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD · Subpart C-Hazard Analysis and Risk-Based Preventive Controls
Key facts
| Citation | 21 CFR 117.160(b) |
|---|---|
| Section | Validation |
| Part | PART 117-CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD |
| Subpart | Subpart C-Hazard Analysis and Risk-Based Preventive Controls |
| Subchapter | 21 CFR B Food |
| Product types cited | Food/Cosmetics |
| Regulation text (excerpt) | (b) The validation of the preventive controls: (1) Must be performed (or overseen) by a preventive controls qualified individual: (i) (A) Prior to implementation of the food safety plan; or (B) When necessary to demonstrate the control measures can be implemented as designed: (1) Within 90 calendar days after production of the applicable food first begins; or (2) Within a reasonable timeframe, provided that the preventive controls qualified individual prepares (or oversees the preparation of) a… |
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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.