Peptidetesting

Back to the glossary

Regulation

HACCP

HACCP (Hazard Analysis and Critical Control Points) is a preventive food-safety management system. It is not a laboratory test. HACCP identifies and controls biological, chemical, and physical hazards during food production; it does not measure the purity or identity of a peptide or research chemical.

Also called: Hazard Analysis and Critical Control Points

HACCP (Hazard Analysis and Critical Control Points) is a systematic, science-based food-safety management framework that prevents hazards through preventive process control. Originally developed in the 1960s for NASA's space-food program and framed by the FDA, this system focuses on the production line rather than finished-product testing to ensure safety from raw material production through to consumption.

The seven principles of the HACCP framework

  • Conduct a hazard analysis.
  • Determine critical control points (CCPs).
  • Establish critical limits.
  • Set monitoring procedures.
  • Define corrective actions.
  • Verify that the system works.
  • Maintain documentation.

Limitations of HACCP claims for research peptides

HACCP claims for research peptides refer only to the facility's food-safety process controls and do not verify peptide identity, purity, or molecular weight. This framework does not address residual solvents, heavy metals, or COA evidence. These specific quality requirements are met through analytical methods like HPLC and mass spectrometry, or quality systems such as GMP.

HACCP is often confused with GMP (Good Manufacturing Practice), the standard for pharmaceutical-grade peptides that requires finished-product testing. It is also distinct from GLP (Good Laboratory Practice), which covers safety studies, and HARPC, the successor framework under the FDA's Food Safety Modernization Act. For a valid Certificate of Analysis, HPLC purity data and mass-spectrometry identity confirmation are the essential evidence.

Sources

  1. HACCP Principles & Application Guidelines
  2. GMP vs. GLP in Laboratory Testing & Validation
  3. Hazard Analysis Critical Control Point (HACCP)
  4. Regulatory Guidelines for the Analysis of Therapeutic Peptides and ...
  5. Reference Standards to Support Quality of Synthetic Peptide Therapeutics - PMC
  6. HPLC Analysis and Purification of Peptides - PMC
  7. HARPC vs. HACCP: What Changed Under FSMA | The FDA Expert
  8. The hazard analysis and critical control point system in food safety - PubMed
  9. Annex 1 WHO good practices for pharmaceutical quality control laboratories
  10. HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS APPLICATION
  11. HPLC vs Mass Spectrometry for Peptide Purity Testing
  12. [PDF] Quality control in peptide manufacturing: specifications for GMP ...
  13. Key Considerations for GMP Compliance in Peptide Drug ...
  14. HACCP Compliance for Food-Grade Chemicals - Allan Chemical Corporation | allanchem.com
  15. GMP vs HACCP - Difference and Comparison | Diffen
  16. GMP, GLP or ISO 17025:
  17. HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS APPLICATION