Part 117 — Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
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
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.