Title 21

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 Authority:21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note, 371, 374; 42 U.S.C. 243, 264, 271. Source:80 FR 56145, Sept. 17, 2015, unless otherwise noted. Editorial Note:Nomenclature changes to part 117 appear at 81 FR 49896, July 29, 2016.

21:2.0.1.1.16.1SUBPART A
Subpart A - General Provisions
21:2.0.1.1.16.1.1.1SECTION 117.1
   117.1 Applicability and status.
21:2.0.1.1.16.1.1.2SECTION 117.3
   117.3 Definitions.
21:2.0.1.1.16.1.1.3SECTION 117.4
   117.4 Qualifications of individuals who manufacture, process, pack, or hold food.
21:2.0.1.1.16.1.1.4SECTION 117.5
   117.5 Exemptions.
21:2.0.1.1.16.1.1.5SECTION 117.7
   117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food.
21:2.0.1.1.16.1.1.6SECTION 117.8
   117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities.
21:2.0.1.1.16.1.1.7SECTION 117.9
   117.9 Records required for this subpart.
21:2.0.1.1.16.2SUBPART B
Subpart B - Current Good Manufacturing Practice
21:2.0.1.1.16.2.1.1SECTION 117.10
   117.10 Personnel.
21:2.0.1.1.16.2.1.2SECTION 117.20
   117.20 Plant and grounds.
21:2.0.1.1.16.2.1.3SECTION 117.35
   117.35 Sanitary operations.
21:2.0.1.1.16.2.1.4SECTION 117.37
   117.37 Sanitary facilities and controls.
21:2.0.1.1.16.2.1.5SECTION 117.40
   117.40 Equipment and utensils.
21:2.0.1.1.16.2.1.6SECTION 117.80
   117.80 Processes and controls.
21:2.0.1.1.16.2.1.7SECTION 117.93
   117.93 Warehousing and distribution.
21:2.0.1.1.16.2.1.8SECTION 117.95
   117.95 Holding and distribution of human food by-products for use as animal food.
21:2.0.1.1.16.2.1.9SECTION 117.110
   117.110 Defect action levels.
21:2.0.1.1.16.3SUBPART C
Subpart C - Hazard Analysis and Risk-Based Preventive Controls
21:2.0.1.1.16.3.1.1SECTION 117.126
   117.126 Food safety plan.
21:2.0.1.1.16.3.1.2SECTION 117.130
   117.130 Hazard analysis.
21:2.0.1.1.16.3.1.3SECTION 117.135
   117.135 Preventive controls.
21:2.0.1.1.16.3.1.4SECTION 117.136
   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.
21:2.0.1.1.16.3.1.5SECTION 117.137
   117.137 Provision of assurances required under § 117.136(a)(2), (3), and (4).
21:2.0.1.1.16.3.1.6SECTION 117.139
   117.139 Recall plan.
21:2.0.1.1.16.3.1.7SECTION 117.140
   117.140 Preventive control management components.
21:2.0.1.1.16.3.1.8SECTION 117.145
   117.145 Monitoring.
21:2.0.1.1.16.3.1.9SECTION 117.150
   117.150 Corrective actions and corrections.
21:2.0.1.1.16.3.1.10SECTION 117.155
   117.155 Verification.
21:2.0.1.1.16.3.1.11SECTION 117.160
   117.160 Validation.
21:2.0.1.1.16.3.1.12SECTION 117.165
   117.165 Verification of implementation and effectiveness.
21:2.0.1.1.16.3.1.13SECTION 117.170
   117.170 Reanalysis.
21:2.0.1.1.16.3.1.14SECTION 117.180
   117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor.
21:2.0.1.1.16.3.1.15SECTION 117.190
   117.190 Implementation records required for this subpart.
21:2.0.1.1.16.4SUBPART D
Subpart D - Modified Requirements
21:2.0.1.1.16.4.1.1SECTION 117.201
   117.201 Modified requirements that apply to a qualified facility.
21:2.0.1.1.16.4.1.2SECTION 117.206
   117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.
21:2.0.1.1.16.5SUBPART E
Subpart E - Withdrawal of a Qualified Facility Exemption
21:2.0.1.1.16.5.1.1SECTION 117.251
   117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.2SECTION 117.254
   117.254 Issuance of an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.3SECTION 117.257
   117.257 Contents of an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.4SECTION 117.260
   117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.5SECTION 117.264
   117.264 Procedure for submitting an appeal.
21:2.0.1.1.16.5.1.6SECTION 117.267
   117.267 Procedure for requesting an informal hearing.
21:2.0.1.1.16.5.1.7SECTION 117.270
   117.270 Requirements applicable to an informal hearing.
21:2.0.1.1.16.5.1.8SECTION 117.274
   117.274 Presiding officer for an appeal and for an informal hearing.
21:2.0.1.1.16.5.1.9SECTION 117.277
   117.277 Timeframe for issuing a decision on an appeal.
21:2.0.1.1.16.5.1.10SECTION 117.280
   117.280 Revocation of an order to withdraw a qualified facility exemption.
21:2.0.1.1.16.5.1.11SECTION 117.284
   117.284 Final agency action.
21:2.0.1.1.16.5.1.12SECTION 117.287
   117.287 Reinstatement of a qualified facility exemption that was withdrawn.
21:2.0.1.1.16.6SUBPART F
Subpart F - Requirements Applying to Records That Must Be Established and Maintained
21:2.0.1.1.16.6.1.1SECTION 117.301
   117.301 Records subject to the requirements of this subpart.
21:2.0.1.1.16.6.1.2SECTION 117.305
   117.305 General requirements applying to records.
21:2.0.1.1.16.6.1.3SECTION 117.310
   117.310 Additional requirements applying to the food safety plan.
21:2.0.1.1.16.6.1.4SECTION 117.315
   117.315 Requirements for record retention.
21:2.0.1.1.16.6.1.5SECTION 117.320
   117.320 Requirements for official review.
21:2.0.1.1.16.6.1.6SECTION 117.325
   117.325 Public disclosure.
21:2.0.1.1.16.6.1.7SECTION 117.330
   117.330 Use of existing records.
21:2.0.1.1.16.6.1.8SECTION 117.335
   117.335 Special requirements applicable to a written assurance.
21:2.0.1.1.16.7SUBPART G
Subpart G - Supply-Chain Program
21:2.0.1.1.16.7.1.1SECTION 117.405
   117.405 Requirement to establish and implement a supply-chain program.
21:2.0.1.1.16.7.1.2SECTION 117.410
   117.410 General requirements applicable to a supply-chain program.
21:2.0.1.1.16.7.1.3SECTION 117.415
   117.415 Responsibilities of the receiving facility.
21:2.0.1.1.16.7.1.4SECTION 117.420
   117.420 Using approved suppliers.
21:2.0.1.1.16.7.1.5SECTION 117.425
   117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).
21:2.0.1.1.16.7.1.6SECTION 117.430
   117.430 Conducting supplier verification activities for raw materials and other ingredients.
21:2.0.1.1.16.7.1.7SECTION 117.435
   117.435 Onsite audit.
21:2.0.1.1.16.7.1.8SECTION 117.475
   117.475 Records documenting the supply-chain program.