HACCP

Hazard Analysis and Critical Control Points

HACCP shifts food safety from “test the finished product” to “design and control the process so hazards never reach the consumer.” A team analyses each step of the operation, decides where a control is essential (a Critical Control Point, or CCP), sets a measurable limit at that point, and monitors it continuously — so a loss of control is caught and corrected before product ships.

In the United States, HACCP is mandatory for seafood (21 CFR 123) and juice (21 CFR 120), and its logic underpins the FSMA Preventive Controls rule for human food (21 CFR 117), sometimes called HARPC. Internationally it is defined by the Codex Alimentarius General Principles of Food Hygiene (CXC 1-1969). The same hazard-analysis discipline maps directly onto pharmaceutical Quality Risk Management under ICH Q9.

• —Principle 1 — Conduct a hazard analysis (identify biological, chemical, and physical hazards).
• —Principle 2 — Determine the Critical Control Points (CCPs).
• —Principle 3 — Establish critical limits for each CCP.
• —Principle 4 — Establish monitoring procedures.
• —Principle 5 — Establish corrective actions when a limit is breached.
• —Principle 6 — Establish verification procedures.
• —Principle 7 — Establish record-keeping and documentation.

Codex Alimentarius CXC 1-1969 (General Principles of Food Hygiene, incl. the HACCP annex); US: 21 CFR 117 (Preventive Controls for Human Food), 21 CFR 120 (juice HACCP), 21 CFR 123 (seafood HACCP).