Dr. Xie's Jing Tang Herbal Quality Control Procedure
Herbal quality control is essential and the first priority of Dr. Xie’s Jing Tang Herbal. The following is our quality control procedure for all herbal products we manufacture or distribute.
1. Good Manufacturing Practices (GMP) standard
All raw material and herbal products comply with the US FDA Dietary Supplements cGMP Final Rules and stringent Chinese Good Manufacturing Practices (GMP) for pharmaceutical products, and have also been certified by the Australian Therapeutic Goods Administration (TGA).
GMP certification means that the site and methods employed in the production of our herbs have been subject to a thorough quality control investigation and have been certified to be in compliance with GMP guidelines. Guidelines vary from country to country. In China, the standards for Chinese herbal manufacture are same as pharmaceuticals.
The certification process covers everything from the building and grounds, equipment, personnel and training, sanitation and hygiene, air and water purification, production and documentation. The standards for manufacturing are the guidelines upon which our manufacturers base each decision, and allow us to have the confidence to say that they are some of the best herbal product manufacturers not only in China, but also in the world today.
2. Laboratory Testing
Each of the internationally GMP certified factories where our herbal products are produced has an in-house lab where extensive quality control analysis is performed. All raw materials are identified and basic tests are performed before use. Chemical analyses including TLC (thin layer chromatography) and HPLC (high performance liquid chromatography) are also used to confirm identification, ensure potency and to test for active constituents when necessary.
Tests for moisture content, dissolution, heavy metals (lead, arsenic, mercury, cadmium), pesticide residue, and microbial content (including bacteria and fungi) are performed on every batch of finished product. Restrictions on heavy metal and microbial contaminants are stringent and in accordance with international requirements. Following extensive in-house testing, heavy metal testing is conducted again at third party labs to confirm results and to ensure that our standards of purity and safety are met. More sophisticated analyses, such as aristolochic acid testing and chloramphenicol testing, are conducted at outside certified labs.
When the products arrive in the U.S. they are subject to an additional review by the FDA ensuring that the products you receive meet every safety standard.
3. Certificate of Analysis
Certificates of analysis for herbal quality are provided via the independent laboratories.
4. Tracking System
The name of our herbals are used with both Pin-yin and Latin to avoid any confusion.
A lot number is used as a trucking number for each product. Each product from pulling individual raw herbs to blending them, and from packing and labeling to shipping is dated and signed by the person who makes this product and handle this order, and then each product/order is double-checked, dated and signed by the second person.
Each product is labeled with the production date and expiration date.
5. Monitoring System
Dr. Xie’s Jing Tang Herbal Inc. has two independent laboratories in China, Zhejiang University Department of Veterinary Medicine in Hang-zhou, Zhejiang, and Southwest University International Chi Institute in Chong-qing, China. The samples of our herbal products are regularly sent to these labs for full quality control required analysis: purity, potency, cleanliness, heavy metal, microbial content etc. using microscopy, thin layer chromatography (TLC), high performance liquid chromatography (HPLC) and gas chromatography/mass spectrometry (GC/MS).
6. Controlling the sources
Similar to grapes grown for wine, different growing conditions produce varying qualities of herbs. Climate, soil and weather changes all contribute to the final product and can affect the potency and effectiveness of a particular herb. Therefore, it is crucial to know where and when each herb is harvested. Chinese herbs can be categorized as top, middle and low grade.
To ensure the herbal quality and efficacy, we have always used only top grade herbs for all of our formulas.