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