Herbal Ingredients Quality Control and Product Safety
date:2016-03-22
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On the China Natural Ingredient Conference 2015, He Jian, engineer of the Science&Technology Center of By-health, shares some knowledge about quality control and product safety of natural ingredients on behalf of Qian Wei, director of the Science&Technology Center of By-health.
 
Founded in Oct. 1995, By-health introduced the dietary supplements into the non-direct selling system of China in a systematic way in 2002, and fast grew into a leader and benchmark enterprise in China’s dietary supplement field and became the first to be awarded AAA Credit Level in health care industry of China.
 
As the first transparent manufacturer in health care industry, By-health makes its ingredient processing transparent. The supplier audit method and global ingredient tracking system as adopted by the company have great value of promotion.
  
Quality Control of Plant Extracts
Quality control of plant extracts are performed by China Food and Drug Administration(CFDA). Extracts from immature citron, Chinese angelica, hyperforin perforatum, ginseng, huckleberry, gingko extract and silymarin as produced by By-health are all compliant with relevant laws and regulations of China.
 
Supplier Audit
Supplier audit includes qualification audit and onsite audit. Qualification audit involves review on the Business License, Medicine Production Permission, Operation Permission, GMP Certificate, Ingredient Production Instruction, Instruction on Import Medicines for import ingredients, and accessory production instruction; and onsite audit includes qualification confirmation, review on institute and personnel, management of plant and equipment, material management, production management and quality management.
 
Audit results:
Class A: excellent supplier
Class B: good supplier
Class C: accepted supplier
 
Quality Standard for Plant Extract
Quality standard for plant extract includes the formulation reference and standard components. The formulation references include laws, regulations, product certificates and production processes. Standard components then cover ingredient source, production process, physical and chemical demand, and microbial requirements.
 
 
Research on Safety of Plant Extracts
Rules of Toxicological Evaluation and Test
 
Traditional process Consumption more than recommended or required Test of acute toxicity and 28-day toxicity
Non-traditional process Organic solvent and purely chemical process Test of acute toxicity, genetic toxicity and 28-day toxicity
New ingredients Provide edible history, inspection of harmful components, and safety evaluation literature Toxicity test according to actuality
 
By-Health Global Raw Material Traceability System:

 
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