CFR section
21 CFR 117.145(c)(1): Monitoring
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 117.145(c)(1) |
|---|---|
| Section | Monitoring |
| 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) | (1) Requirement to document monitoring. You must document the monitoring of preventive controls in accordance with this section in records that are subject to verification in accordance with § 117.155(a)(2) and records review in accordance with § 117.165(a)(4)(i). |
At a glance
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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.