FDA 21 CFR Part 117 Food cGMP and Preventive Controls
Food safety preventive controls, hazard analysis, cGMP and supply chain controls for human food.
Sectors
Articles (61)
§ 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.§ 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.§ 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facility exemption.§ 117.284 Final agency action.§ 117.287 Reinstatement of a qualified facility exemption that was withdrawn.§ 117.301 Records subject to the requirements of this subpart.§ 117.305 General requirements applying to records.§ 117.310 Additional requirements applying to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.§ 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.§ 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.§ 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.§ 117.126 Food safety plan.§ 117.130 Hazard analysis.