21 CFR Part 117 - CGMP, Hazard Analysis and Risk-Based Preventive Controls for Human Food

What it says

Facilities that manufacture, process, pack or hold human food and are required to register with FDA must follow current good manufacturing practices and implement a written food safety plan, prepared or overseen by a Preventive Controls Qualified Individual, that identifies hazards and applies risk-based preventive controls, with monitoring, corrective actions, verification and records. Exemptions and modified requirements apply to some facilities, such as qualified facilities.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This rule moved food safety from reacting to problems to preventing them, so the written food safety plan is the center of an inspection, not a binder kept for show.
• Part 117 combines two layers, the baseline sanitation and operating practices in Subpart B, and the hazard-specific preventive controls that follow from the plant's own hazard analysis.
• Whether a facility is exempt or subject to modified requirements depends on its size and activities, so determining its status and keeping that determination documented is the first step.

What FDA inspectors look for

• Whether a written food safety plan exists and was prepared or overseen by a qualified individual.
• Whether the hazard analysis, preventive controls, monitoring and verification records are consistent with each other and with what actually happens on the line.
• Whether the facility's exemption or modified-requirement status, if claimed, is documented and supported.

Related regulations