21 CFR PART 117
21 CFR Part 117
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
FDA's foundational food-safety rule under FSMA. Covers GMPs, written food-safety plans, hazard analysis, preventive controls, supply-chain programs, recall plans, and recordkeeping for most domestic and imported human food facilities.
- Subpart AGeneral Provisions
- § 117.1Applicability and status
- § 117.3Definitions
- § 117.4Qualifications of individuals who manufacture, process, pack, or hold food
- § 117.5Exemptions
- § 117.7Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food
- § 117.8Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities
- § 117.9Records required for this subpart
- Subpart BCurrent Good Manufacturing Practice
- § 117.10Personnel
- § 117.20Plant and grounds
- § 117.35Sanitary operations
- § 117.37Sanitary facilities and controls
- § 117.40Equipment and utensils
- § 117.80Processes and controls
- § 117.93Warehousing and distribution
- § 117.95Holding and distribution of human food by-products for use as animal food
- § 117.110Defect action levels
- Subpart CHazard Analysis and Risk-Based Preventive Controls
- § 117.126Food safety plan
- § 117.130Hazard analysis
- § 117.135Preventive controls
- § 117.136Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control
- § 117.137Provision of assurances required under § 117.136(a)(2), (3), and (4)
- § 117.139Recall plan
- § 117.140Preventive control management components
- § 117.145Monitoring
- § 117.150Corrective actions and corrections
- § 117.155Verification
- § 117.160Validation
- § 117.165Verification of implementation and effectiveness
- § 117.170Reanalysis
- § 117.180Requirements applicable to a preventive controls qualified individual and a qualified auditor
- § 117.190Implementation records required for this subpart
- Subpart DModified Requirements
- Subpart EWithdrawal of a Qualified Facility Exemption
- § 117.251Circumstances that may lead FDA to withdraw a qualified facility exemption
- § 117.254Issuance of an order to withdraw a qualified facility exemption
- § 117.257Contents of an order to withdraw a qualified facility exemption
- § 117.260Compliance with, or appeal of, an order to withdraw a qualified facility exemption
- § 117.264Procedure for submitting an appeal
- § 117.267Procedure for requesting an informal hearing
- § 117.270Requirements applicable to an informal hearing
- § 117.274Presiding officer for an appeal and for an informal hearing
- § 117.277Timeframe for issuing a decision on an appeal
- § 117.280Revocation of an order to withdraw a qualified facility exemption
- § 117.284Final agency action
- § 117.287Reinstatement of a qualified facility exemption that was withdrawn
- Subpart FRequirements Applying to Records That Must Be Established and Maintained
- § 117.301Records subject to the requirements of this subpart
- § 117.305General requirements applying to records
- § 117.310Additional requirements applying to the food safety plan
- § 117.315Requirements for record retention
- § 117.320Requirements for official review
- § 117.325Public disclosure
- § 117.330Use of existing records
- § 117.335Special requirements applicable to a written assurance
- Subpart GSupply-Chain Program
- § 117.405Requirement to establish and implement a supply-chain program
- § 117.410General requirements applicable to a supply-chain program
- § 117.415Responsibilities of the receiving facility
- § 117.420Using approved suppliers
- § 117.425Determining appropriate supplier verification activities (including determining the frequency of conducting the activity)
- § 117.430Conducting supplier verification activities for raw materials and other ingredients
- § 117.435Onsite audit
- § 117.475Records documenting the supply-chain program