Atomy GMP & HACCP Certifications: What They Mean for HemoHIM

GMP and HACCP are internationally recognized quality standards for manufacturing supplements and food products. Atomy and HemoHIM manufacturer Kolmar BNH hold both certifications — plus FDA registration with NAI status. This article explains what these certifications mean and why they matter for consumers.

What Is GMP? (Good Manufacturing Practices)

GMP stands for Good Manufacturing Practices — an internationally recognized quality assurance system used in pharmaceutical and food manufacturing.

GMP requirements include: controlled production environments with defined temperature and hygiene conditions, documented standard operating procedures (SOPs) for every manufacturing step, regular quality controls and laboratory analyses, full traceability of all raw materials and batches, and trained personnel with regular continuing education.

For HemoHIM, GMP certification means every batch is manufactured under pharmaceutical-grade conditions. The three herbal extracts — Angelica gigas, Cnidium officinale, and Paeonia japonica — are extracted and processed under controlled conditions.

What Is HACCP? (Hazard Analysis Critical Control Points)

HACCP is a systematic approach to identifying and controlling hazards in food production. Originally developed by NASA for space food, it is now the global standard for food safety.

The 7 HACCP principles: conduct hazard analysis, determine critical control points (CCPs), establish critical limits, set up monitoring procedures, define corrective actions, establish verification procedures, and maintain documentation.

While GMP ensures overall manufacturing quality, HACCP specifically focuses on preventing contamination and health hazards throughout the entire production chain — from raw materials to finished product.

Kolmar BNH: The Manufacturer Behind HemoHIM

Kolmar BNH (KRX: 200130) is a publicly listed South Korean company and the exclusive manufacturer of HemoHIM. The company holds a comprehensive certification portfolio. Learn more in our Atomy HemoHIM review.

GMP Certification: Kolmar BNH manufactures according to international GMP standards. The production facility in Sejong City, South Korea, undergoes regular audits.

HACCP Certification: The entire production process — from herbal raw material intake to individual sachet packaging — is HACCP certified.

FDA Registration (USA): Kolmar BNH is registered with the US FDA and received NAI status (No Action Indicated) — the best possible result from an FDA inspection. Details in our article Is HemoHIM FDA approved?

TGA Recognition (Australia): Australia's Therapeutic Goods Administration (TGA) is known for its particularly strict standards. HemoHIM has received TGA recognition.

MFDS Approval (South Korea): Korea's Ministry of Food and Drug Safety has recognized HemoHIM as an Individual Health Functional Food — a specific regulatory category for products with proven health effects.

What These Certifications Mean for Consumers

For consumers, GMP and HACCP certifications are important quality indicators:

Product Safety: Every HemoHIM batch is tested for heavy metals, pesticides, and microbiological contamination. Clinical study safety data confirms the good safety profile.

Consistency: GMP guarantees that every package contains the same quality and active ingredient concentration. The patented three-herb formula is manufactured to standardized specifications.

Transparency: All certifications are verifiable. FDA registration is publicly accessible, and GMP/HACCP audits are conducted by independent third parties.

GMP vs. HACCP: Key Differences

GMP covers the entire manufacturing practice — facilities, equipment, personnel, documentation, and quality control. It ensures products are consistently made to high standards.

HACCP specifically focuses on identifying and preventing hazards — biological (bacteria), chemical (pesticides), and physical (foreign objects) contamination. It is a risk-based prevention system.

Together, GMP and HACCP form a comprehensive quality and safety system. The combination means HemoHIM is not only manufactured to high standards but also systematically protected against potential hazards.

Bottom Line

HemoHIM and its manufacturer Kolmar BNH hold GMP and HACCP certifications, FDA registration with NAI status, TGA recognition, and MFDS approval. For a complete overview of HemoHIM — including ingredients, benefits, and how to take it — visit our complete guide.