CFR section
21 CFR 117.165(b): Verification of implementation and effectiveness
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 117.165(b) |
|---|---|
| Section | Verification of implementation and effectiveness |
| 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 | Drugs, Food/Cosmetics, General |
| Regulation text (excerpt) | (b) Written procedures. As appropriate to the facility, the food, the nature of the preventive control, and the role of the preventive control in the facility's food safety system, you must establish and implement written procedures for the following activities: (1) The method and frequency of calibrating process monitoring instruments and verification instruments (or checking them for accuracy) as required by paragraph (a)(1) of this section. (2) Product testing as required by paragraph (a)(2)… |
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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.