Authentic Raw Materials - Dao Di Sourcing
A conflict exists between small Chinese herbal growers and the big markets and large circulations. Small scale farmers have limited planning ability, with poor quality and low accountability. It is difficult for them to enter the big market. In order to solve the problem, to connect small farmers with large markets and meet the requirements of economic development, systematic innovation in an organization must be carried out. It must protect the sustainability and ensure traceability and continuity of Chinese herbal resources, and stabilize the price by reducing malicious competition.
Tianjiang has developed a system of Managing Quality Deviation in Raw Materials by protecting the sustainability and continuity of raw material resources, and by ensuring traceability.
1.Raw Material Planting Base:
From the herbal cultivation to the construction of the planting base, from the standardized raw herbal material processing and decoction procedures to the computerized and standardized extraction process, Tianjiang has engaged in comprehensive quality control standards that will ensure the quality of our final products. The base construction model is: “company + regional supplier + plantation base,” resource sharing, and forming strategic alliances. As of November 2018, our company has established 111 GAP planting bases with 52 Chinese medicine companies and cooperatives in the country. The base strictly implements GAP standards. Tianjiang Pharmaceutical and the cooperation companies have signed joint construction agreements involving 126 varieties of Chinese medicinal herbs in the country.
2. Plant Breeding Research:
Tianjiang formed a school-enterprise consortium with China Pharmaceutical University’s Department of Genetics and Breeding, specializing in the cultivation and demonstration of selected varieties of Chinese herbs. It has put scientific and technological achievements of the pharmaceutical sciences to practical application.
3.Raw Material Quality Control:
The key factors in quality control for Raw Materials are controlling the quality of raw materials from the source, cultivating high-quality seedlings, guiding the planting process from its origin, and stabilizing the planting base source. We have developed a raw material quality deviation management system for more than 480 varieties of plants.
A. Raw Material Planting Management:
· Origin (Stable)
· Site of Production (Stable)
· Period of Growth
· Time of Harvest
· Processing Methods
· Environment (Soil, Water, Weather)
· Grade Specification
B. Raw Material Quality Evaluation System:
· Inspection (including toxicity, etc.)
· Chemical Constituents Determination
· Mass Spectrometry
4. Raw Material Safety Related Quality Control:
Tianjiang formed a school-enterprise consortium with China Pharmaceutical University, Department of Genetics and Breeding, specializing in the cultivation and demonstration of selected varieties of Chinese herbs. It has put scientific and technological achievements of the Pharmaceutical Science to real uses.
Comparison of detoxified chrysanthemum (left) and unsterilized chrysanthemum (right) of detoxified
chrysanthemum tube seedlings at different growth stages
Virus-free Chrysanthemum Plantation Base in Yanma Town
In response to the endogenous factors affecting the safety of herbal products, the company has strengthened its research on the origin, pre-processing and planting 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, to 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 are carried out. The 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.
Heavy Metal control
Based on the company quality control research results, there are over 60 varieties of raw materials shown heavy metals exceeding the standard limits commonly. The company has taken targeted measures to limit of heavy metal in these products.
Optimize the origin of raw materials: comparing the samples collected determining the safe origin of raw medicinal materials by examining the soil, water, and air of the plantation area and.
Study the enrichment characteristics of heavy metals in different herbal materials and the characteristics of heavy metals in different parts of plants and guide the selection of planting varieties.
Incorporate heavy metals into routine inspection projects, refer to national standards for heavy metals, establish internal control standards that meet international and the USP requirements, and implement internal testing of raw materials and routine testing of finished products.
Pesticide residue control
Tianjiang's comprehensive monitoring testing detected that there are nearly 20 varieties of raw material that are prone to excessive pesticide residues. The company have listed them as key varieties and applied two control measures.
Establish plantation base or a cooperative plantation base at suitable sites, strengthening field management, and reduce the use of pesticides.
Establish internal control standards for pesticide residues and test pesticide residues before extraction. Any non-conforming product shall be re-inspected in-site.
According to Tianjiang's quality control research, there are more than 10 varieties of herbs on the general herbal markets to have aflatoxin exceeding the standard limitation, 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.
One is to construct or incorporate raw material production bases and impose standard operating procedures of processing. 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.
For varieties that are difficult to preserve, the raw material is supplied in season. For example, fresh Corydalis root needs to be dried immediately to prevent molding. The company requires cooperative plantation bases to dry newly harvested raw materials immediately and to arrange extraction in the shortest time possible.
Sulfur dioxide residue control
According to the general herbal material market, Sulfur fumigation is one of the commonly used methods to prevent mildew and insects, so excessive sulfur in the end product occurs in the herbal material. Tianjiang Pharmaceutical has conducted a comprehensive census and found that more than 60 varieties of sulfur dioxide often exceeded the limits. The company established strict internal control standards to control sulfur dioxide with reference to international testing methods and standards.
5.Traceability Platform for Monitoring Safety and Product Quality:
The whole-process-tracking-management not only strengthens the quality management and reduces the cost of error correction, but it also facilitates the collection of commodity information and consumer trends, thus improving the company’s rapid response capability. In the field of process manufacturing, especially in the production of pharmaceuticals, the establishment of a product quality traceability system has become one of the important management tools that companies can rely upon.
The traceability platform records and manages all the data involved from raw materials to final products, so that the whole process becomes traceable and transparent.
The quality traceability platform is divided into 7 major modules: seed/seedlings, growing practices, single herb production, patented formula production, commercial circulation, information services, and system management.
The tracing data consists of three main components: production, supply, and marketing. Our company manages two major data sources: herb cultivation and granule production. The cultivation part includes farmer's files and growing environment data, etc.; the granule production part covers steps from purchasing raw material to finished products release.
6. Quality Control of the Pre-extracting Treatments of Raw Herbs-Pao Zhi
Tianjiang follows the principle of “Authentic Materials, Traditional Processing.”-Pao Zhi. Tianjiang uses traditional processing techniques, combined with modern research, following closely with the specifications of Chinese Pharmacopoeia, quantified traditional Chinese medicine processing, and established a set of company standards for Chinese herbal processing (Standard of Processing SOP).
Example: fried Bai Shao (with different frying times)
Description of chalky traits in different frying time
According to the production tracking and experimental results, the production process of the white peony is tentatively determined: according to the requirements of the Chinese Pharmacopoeia, the appearance of the fried white peony is: the surface is slightly yellow, with the visible burned spot. According to the data of the content determination, the best process is that the cooking time is 8 minutes.