Traceable Platform for Monitoring
Safety and Product Quality
Full traceability and Quality Control Through Every Process from Seed to Finished Products
The whole-process- tracking-management not only strengthens the quality management, reduces the cost of error correction, but also facilitates the collection of commodity information and consumer trends and thus improves the company’s rapid response capability. In the field of process manufacturing, especially in the production of pharmaceuticals, the establishment of a product quality traceable system has become one of the important management tools that companies rely upon.
1. The traceable platform records and manages all the data involved from raw materials to final products, so that the whole process becomes traceable and transparent.
2. The quality traceable platform is divided into 6 major modules: seed/seedlings, growing practices, single herb production, formula production, storage and transportation, commercial circulation. It essentially covers the entire circulation of our products.
3. The tracing data consists of three main parts: production, supply and marketing. Our company manages two major data sources: herb cultivation and granules production. The cultivation part includes farmers’ files and growing environmental data, etc.; the granule production part covers steps from raw material to finished products release.
Vertical Quality Control Procedures
Quality Seeds Selection
Good seeds are the first step to guarantee high-quality herbal extracts. Due to the deterioration of existing varieties of Chinese herbal raw materials, the efficacy of Chinese herbal materials at present is less powerful than it has been in the past. In modern agriculture, after one variety goes through 3 cycles of plantation, the efficacy of the resulting crops will be reduced and they may be more susceptible to viruses and pests, so as to cause pathological changes and finally lead to decreased quality of Chinese herbal materials. One of the main solutions is to establish a Good Agriculture and Collection Practice (GACP) cultivation base. To fundamentally solve these problems, Tianjiang has worked cooperatively with Genetics and Breeding Teaching and Research Section of China Pharmaceutical University 中国药科大学 on the research and application of fine varieties of medicinal materials. From seeds to the plantation of traditional Chinese herbs, Tianjiang is working to develop top-quality of herbal seeds and crops.
Tianjiang established multiple Good Agriculture and Collection Practice (GACP) farm to grow authentic herbs. Raw herbs sold on the herbal market face degradation issues in prolonged storage, improper storage condition, and inappropriate harvesting time. They also face herbal damages from mildew, worms, oil leakage, airing, loss of aroma and flavor. This causes property loss, deterioration and even affects the efficacy of the herbs. Therefore, the company uses fresh seasonal raw materials from the right season or in the same year of harvest. That includes plants, nuts and kernels, and flower raw materials. The goal is to guarantee only the raw herbs with high quality, safety, stability, and controllability are selected to put into the next step of production.
Tianjiang considers quality control of raw materials as a top priority. The quality of materials is closely related to their places of origin, harvesting season, processing method and storage conditions. Besides using raw herbs from Tianjiang's own GAP plantations, raw herbs are sourced through established relationships at over 320 farms (include 110 company owed GACP farms) and production regions spanning 22 provinces in China. Many individual herbs come from GACP certified farms or ethically wild-crafted sources. At present, nearly 430 varieties of raw herbs are directly from classical origins. Only raw materials pass the inspection of quality control in seeding, growing, harvesting, restoring, and production. Tests in authentication to detect heavy metals, pesticide residues, flavacin, and sulfur dioxide are performed. Sulfur is never used on the incoming raw herbs.
Traditional Processing and Verification (Pao Zhi)
Chinese medicine has thousands of years of history of processing (Pao Zhi) herbs to reduce toxicity and increase effectiveness. Tianjiang follows the specifications of the Chinese Pharmacopoeia and standardizations in the whole preparation process strictly and adopts the modern science and technology to receive the best of two worlds. The methods conducted in processing raw herbs are: Stir-fried with liquid adjuvants, steaming, parching, germinating, fermenting and freezing. Studies are conducted on processing technology to figure out the effects of the parameters of processing raw herbs, and the changes to the effective constituent and the content with different processing methods and the extraction ratio of effective constituent. Tianjiang has carried out a large number of studies on the determination of specific particle size to ensure the best practice of extraction and made a requirement that all the particle size margins are to be less than 5%. The key factor of traditional Pao Zhi is seen in the difference from the granule herbs produced in Japan, South Korea, and European countries.
Extracted with only purified water to replicate a traditional decoction in order to reach the full spectrum of ingredients and balance the herbs. While conducting the modern technology extraction, consideration is taken on the control of temperature, pressure and water adjustment, length of the decoction, and adopting the traditional pre-decocting, after-decocting, mild fire and strong fire methods, rather than using chemical substances. Water-based full-spectrum extraction maintains the balance of characteristics of the original plant, which helps to ensure the safety and effectiveness of the herbal extracts.
Manufacturing Process Monitoring
Tianjiang products are produced in accordance with the Good Manufacture Practice (GMP). The workshop is an ISO Class 6 clean room and the company takes strict control of the entire process from raw materials selection, processing, production to packaging, which can provide a reliable guarantee for stable quality, efficiency, and safety. Tianjiang established a three-level quality system network, strengthening the control of the production process as well as effectively ensuring the stability, uniformity and effectiveness of the quality of products. Established standard production processes of Five Quality Control step checking system (raw material, decoction, fluid extract, semi-finished products, and finished products) which includes detection of more than 100 quality control points: amount of water added, length of decoction, temperature of decoction, spray drying inlet, outlet air temperature, contraction temperature, and extract weight. A computerized digital control system is implemented during the production procedure to ensure consistency.
Quality Control Tests
In order to guarantee the safety, effectiveness and stability of single Chinese herbal granules, Tianjiang established a laboratory at the national level taking quality monitoring on the whole process, from seed to finished products and made a quality monitoring system from original herbs, extract, self-finished products to finished products. Laboratories use state-of-the-art technology to examine variables such as quality, quantification, dissolubility, bacterial levels, heavy metals, pesticide residue and flavacin. The products manufactured by Tianjiang pharmaceutical meet the double requirements of food and drug in China. The company possesses modern analytical and testing instruments such as CAMAG REPROSTAR, HPLC, GC and ICP-AES. High-performance liquid chromatography, gas chromatography are used to determine the content of active ingredients in the granules. Thin layer scanning Fingerprint Technology is used to identify the fingerprint code of each botanical. Tests are verified by independent laboratories in the US and Germany.
Tianjiang herbal extract granules have been accepted and trusted in more than 30 countries and regions across the world, and have been used by China's top AAA level TCM hospitals, and is used by more than 70% of provincial TCM hospitals in China with several hundred million people over 30 years of clinical application. Herbal extract granules have gained increasing popularity among the clinical Chinese medicine practitioners and patients globally.
Adoption of international standards to set up international quality control measures. Tianjiang complies with international standards and has attained EU food and drug standards following German inspection of over 340 of single herb extracts for indexes such as heavy metal, pesticide residue, aflatoxin, and microorganisms. The products are not only popular in China, but are also sold to over 30 countries and regions bringing benefits to millions of people across the globe.
Tianjiang retains samples for different batches of raw materials and finished products, to ensure the traceability of herb quality. Tianjiang has established a digital and computerized mode warehouse for raw materials and finished product management. The same batch of herbal raw materials, finished products and sold products can be traced from the recoding and tracing system. If there is any concern with the quality of the products, the original samples in the lab and remaining products in the warehouse, and the records of origins of farming, the production data, the test results could be traced with the Safety Tracing System.
Field to Shelf Full Traceability
To comply with FDA regulations, Treasure of the East herb distribution developed a specialized bar coding system that is linked to Tianjiang Safety Tracing system. Herbs distributed through Treasure of the East are controlled with a bar code scanning and tracking system which can be traced back to the original source of raw materials and finished product samples at Tianjiang pharmaceutical. This allows practitioners to track every single herb to its original identification from the manufacturer. The tracking system records the information of production date, batch number, test results, and tracks herbs to their original batch samples.
Sample of COAs