Safety Assurance
The company conducts comprehensive testing on products such as heavy metals, pesticide residues, aflatoxin, sulfur dioxide. The products meet the standards of many countries and regions, including Chinese Pharmacopoeia, Europe Pharmacopoeia, the United States Pharmacopoeia and Hong Kong Standard.
The testing capability has been certified by the nationally accredited
laboratory CNAS (ISO 17025)
In response to the endogenous factors affecting the safety of traditional Chinese medicine, the company has strengthened its research on the origin, pre-processing and production processes to ensure its products’ safety and effectiveness. Inductively coupled plasma mass spectrometry was used to detect heavy metals and other harmful elements in raw materials and finished products. The method of gas chromatography and high-performance liquid chromatography was used to detect pesticide residues, sulfur dioxide residues and aflatoxin.
Through the census of multi-batch-samples of all products, more than 100 varieties are selected for stricter inspection on heavy metals and harmful elements, pesticide residues, sulfur dioxide and aflatoxin. These are listed as key research and monitoring varieties and targeted research is carried out. Investigation focused on the causes of the occurrence, explore methods and measures for effective prevention and control, and establish the internal safety standards for key varieties from raw materials to finished products. This has filled some gaps in the quality standards related to the safety index of Chinese herbal extracts.
Heavy metals and other harmful elements control
There were over 60 varieties from different batches shown heavy metals exceeding the standard. Based on the research results, the company has taken targeted measures to limit of heavy metal in these products.
1. Optimize the origin of raw materials: and determine the safe origin of raw medicinal materials by examining the soil, water and air of the production area and comparing the samples collected.
2. Study the enrichment characteristics of heavy metals in different herbal materials and the characteristics of heavy metals in different parts of plants (animals), and guide the selection of planting varieties and the evaluation of the parts.
3. Incorporate heavy metals into routine inspection projects, refer to national standards for heavy metals, establish internal control standards that meet international requirements, and implement internal testing of raw materials and routine testing of finished products.
Pesticide residue control
1. Testing shows that there are nearly 20 varieties of Chinese herbal medicines that are prone to excessive pesticide residues. We have listed them as key varieties and applied two control measures.
2. Establish production base or a cooperative production base at suitable sites, strengthening field management,and reduce the use of pesticides.
3. Establish internal control standards for pesticide residues, and test pesticide residues before production. Any non-conforming product shall be re-inspected in-site.
Aflatoxin control
More than 10 varieties of herbs are selected to have aflatoxin exceeding the standard, such as Suan Zao Ren, peach kernel, and Corydalis. Two strong and effective measures were taken to ensure the quality of raw materials and reduce the level of aflatoxin.
1. One is to construct or incorporate raw material production bases, and impose standard operating procedures of processing. For example, when spiny jujube flesh was removed to produce the kernel (Suan Zao Ren), the old way is to use long-term soaking and pound off the flesh. This method breeds mold, causing aflatoxin to exceed the standard. After confirming the source of the problem, the company established a cooperation base, and requires strict processing of harvesting mature fruits and hand peeling meat.
2. For varieties that are difficult to preserve, the raw material are supplied in season. For example, fresh Corydalis root needs to be dried immediately to prevent molding. The company requires cooperative bases to dry new harvested slices immediately after cooking, and arrange the production by the company in the shortest time possible.
Sulfur dioxide residue control
Sulfur fumigation is one of the commonly used methods for traditional Chinese medicine to prevent mildew and insects, so excessive sulfur in the end product occurs. According to the results of the census of Tianjiang Pharmaceutical, more than 60 varieties of sulfur dioxide often exceeded the standard. With reference to the international testing methods and standards for sulfur dioxide, the company established strict internal control standards.
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