Tuesday, August 18, 2009

Understanding GMP and Quality Control of Chinese Herbs

By Ann Wolman, L.Ac., & Joshua Herr, L.Ac.

Many people are aware that China has made headlines in the last several years for allowing unsafe products to be placed in the marketplace. This has led several patients of the Chinese Acupuncture Clinic to ask about quality control of the herbs that we use.

The Chinese Acupuncture Clinic Dispensary would like to address this concern by informing you about where our Chinese Herbal Products come from and explaining about the quality control of the products we are using. As you know, we have numerous brands of pills, whole herbs, granules, tinctures and essential oils.

Our tinctures and essential oils are the two items we dispense that are not manufactured in China. A company in New Mexico produces the tinctures. Our manufacturers of essential oils are located primarily in Europe. We have concentrated on obtaining the highest quality, internal grade essential oil collection. These essential oils are extracted without the use of solvents, which creates a product that is more potent and suitable for multiple forms of use.

Our manufacturers of pills, whole herbs and granules have been internationally as well as China GMP certified. GMP stands for current Good Manufacturing Practice. This international term is recognized worldwide and is used for the control and management of manufacturing and quality control testing of foods, pharmaceuticals and medical devices. It first appeared in the U.S. as part of the 1938 Food, Drug and Cosmetic Act.

GMP certification means that the facility and methods used in the production of products has been subject to a thorough quality control investigation and is certified to be in compliance. This covers all aspects of manufacturing, including inspection of the building and grounds, the air and water purification systems, the handling and processing of raw herbs, the product manufacturing process, the operation and cleaning of equipment, the training of personnel as well as quality control testing and documentation.

By June of 2010 the manufacture of all dietary supplements in the United States will be subject to national GMP requirements.

The companies that import the herbs we use are responsible for ensuring that manufacturers are adhering to GMP standards. Testing includes moisture content and amounts of heavy metals and mold found in sample batches. An example of how Lanzhou Foci Herb factory reports to Mayway, the company that imports herbs for sale at the Chinese Acupuncture Clinic can be found on the web at www.mayway.com.

Each herbal product manufactured in China is licensed, as drugs are in the U.S., and is produced according to stringent Chinese Pharmacopoeia guidelines and government sanctioned references. This assures that the products are sourced, formulated, extracted and tested according to laboratory and clinical parameters. The high standard for quality control insures consumer safety. Additionally, the FDA monitors the safety of herbal products coming into the country. Chinese herbs are routinely held and inspected, often causing backorders and delays.

The Chinese Acupuncture Clinic Dispensary is dedicated to providing the safest and most effective herbs and herbal products available. We are updated on a regular basis by our distributors and professional organizations regarding herbal medicine safety issues and changes to FDA rules and regulations. We put our patients first when making decisions regarding our herb supply. If you have any questions regarding our products do not hesitate to call the clinic at 828-258-9016.