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GanoHerb Achieves cGMP Certification
Author:
GANOHERB
Source:
Release time:
2024-02-29
On February 3, 2024, Fujian Xianzhilou Biological Science and Technology Co., Ltd. successfully obtained the cGMP certification for dietary supplements (health food) and food products from the United States. This significant certification follows GanoHerb Group's achievement of CNAS laboratory accreditation in 2022 and further underscores their commitment to enhancing quality and food safety.
The cGMP (current Good Manufacturing Practices) for dietary supplements (health food) and food products in the United States is based on the following federal regulations:
1. 21 CFR Part 111: This regulation specifically addresses the production, packaging, labeling, or storage operations of dietary supplements.
2. 21 CFR Part 117: This regulation pertains to current Good Manufacturing Practices (cGMPs) and hazard analysis and risk-based preventive controls for common general food products.
The current Good Manufacturing Practices (cGMPs) for dietary supplements (health food) are the sole national standard in the United States dietary supplement industry. This standard aligns with the FDA's GMP requirements and the regulations set forth by the FDA Food Safety Modernization Act (FSMA).
The cGMP certification audit for dietary supplements (health food) took place from December 4th to 8th, 2023, spanning five days. During this comprehensive audit, cGMP auditors rigorously assessed various aspects of the company, including personnel, factory environment, equipment facilities, GMP documentation system, quality control system, corrective and preventive actions (CAPA), supplier qualification confirmation, environmental monitoring, allergen control, hygiene control, foreign object control, chemical control, pest control, production and process control, packaging and labeling, laboratory control, warehousing, and distribution management.
Following a rigorous and meticulous inspection, the auditor concluded that Fujian Xianzhilou Biological Science and Technology Co., Ltd.'s dietary supplement (health food) production line fully complies with the cGMP standards for U.S. dietary supplements (health food) and food products. As a result, they were awarded the certification.
As of now, GanoHerb has consistently obtained organic certifications from China, United States, Japan, and the European Union, along with GLOBALG.A.P. base certification. Their production line also complies with two crucial international safety management system certifications: ISO 22000:2018 and HACCP. Additionally, the GanoHerb Testing Technology Center has been accredited by CNAS as a laboratory. The recent addition of cGMP certification for dietary supplements (health food) in the United States further validates GanoHerb's commitment to enhancing quality and food safety, and it is expected to facilitate the robust expansion of GanoHerb's health and functional food products in the U.S. market.
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