Quality Assurance and ControlGood Manufacturing Practices (GMP)
Quality assurance starts with the choosing of exceptional manufacturers. Ranked in the top 1% of over 2,000 traditional Chinese medicine manufacturers, all of our manufacturing partners comply with the stringent Chinese Good Manufacturing Practices (GMP), and have also been internationally certified by the Australian Therapeutic Goods Administration (TGA). TGA standards are among the highest in the world, as dietary and herbal supplements there are subject to the same guidelines as pharmaceutical drugs. GMP certification means that the site and methods employed in the creation of our products have been subject to a thorough quality control investigation by a government agency and are certified to be in compliance. The GMP certification process covers all aspects of manufacturing, including inspection of the building and grounds, the air and water purification systems, the handling and processing of raw materials, the product manufacturing process, the operation and cleaning of equipment, the training of personnel, and quality control testing and documentation. Adherence to the GMP guidelines ensures that every batch of product is safe and of the highest quality. These standards for manufacturing are the guidelines upon which our teapill, tablet and extract powder 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.
FDA current Good Manufacturing Practices (cGMP) Certification
Our manufacturers have been internationally as well as China GMP certified for years. Their GMP certifications are for the manufacture of medicinal grade products, and set standards to ensure that our products are safe and effective. As U.S. based manufacturers of herbal products begin to grapple with the implementation of cGMPs for the first time (mandatory by 2009), it is important to note that even when attained, these will be Dietary Supplement GMPs and will not be nearly as rigorous as the pharmaceutical model adhered to by our manufacturers. Mayway applauds the implementation of these much-needed basic standards, and our Oakland facility will be in compliance with the Dietary Supplement cGMPs by June 2009
Pharmacopoeia Guidelines
Our manufacturers adhere to official Chinese Pharmacopoeia guidelines or other government sanctioned references in the making of our products. These references contain individual monographs that have been reviewed and chosen from different references across China by a scientific committee. The monographs specify the ingredients, process, and quality control protocols including testing for active ingredient markers that must be followed in order to legally manufacture a specific formula. Strict adherence to these official guidelines ensures that our products are sourced, formulated, extracted, and tested according to rigorous and detailed parameters that have been not only laboratory tested but clinically tested as well.
Laboratory Testing
Each of the internationally GMP certified factories where our products are manufactured 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 thin layer chromatography (TLC) and high performance liquid chromatography (HPLC), 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) and microbial content are performed on every batch of finished product
3rd Party Laboratory Testing
Mayway’s restrictions on heavy metal and microbial contaminants are stringent, surpassing many international requirements. Following extensive in–house testing at the manufacturing site, heavy metal testing is conducted again at third party labs to confirm results and to ensure that our rigorous standards of purity and safety are met. More sophisticated analyses, such as aristolochic acid testing and chloramphenicol testing as well as testing for DDT and benzene hexachloride, two non–permitted pesticides, are also conducted. All labs used by our manufacturers have been accredited by the China National Accreditation Service for Conformity Assessment and are internationally recognized. They include the following:
Central Laboratory, Gansu Exit-Entry Inspection & Quarantine Bureau http://www.gsciq.gov.cn
China National Analytical Center, Guangzhou http://www.fenxi.com.cn/
These world–renowned laboratories are acclaimed for their third–party testing expertise. The International Laboratory Accreditation Cooperation (ILAC) internationally accredits these facilities, and the quality systems employed are in accordance with the ISO 9001. Their work is accepted around the world.
Mayway’s Heavy Metal Testing Limits
As there were no state or federal heavy metals guidelines for traditional Chinese medicines when we began our voluntary testing program, we had to create our own. The U.S. Pharmacopoeia (USP) determines that safe heavy metal levels for drugs of botanical origin are: lead 10 parts–per–million (ppm), cadmium 3 ppm, arsenic 3 ppm, and mercury 3 ppm.
Our manufacturers are internationally GMP-certified by the Australian Therapeutic Goods Administration (Australia's FDA equivalent) whose guidelines are similar but lower the lead limit to 5 ppm
We decided we could do better. Our expert sourcing and quality control procedures allow us to keep our heavy metal limits below 3 ppm for lead, 2 ppm for arsenic, 0.5 ppm for mercury, and 1 ppm for cadmium for almost all of our products.
Certificates of Analysis
Certificates of Analysis are provided to us by the independent third-party accredited laboratories who test every lot of our herbs, teapills, tablets, liquid extracts and concentrated powders we distribute. Certificates of Analysis are available to our customers upon request.
In–House Quality Control
Inspection and Sampling: In line with Dietary Supplement GMPs, each lot received into our warehouse is first quarantined. Then each product is sampled, the Certificate of Analysis verified, and the sample is compared to past lots for consistency. Herbs are inspected using sensory protocols, and confirmed against standard references if necessary. Quality and species are verified.
Lot Numbers
In addition to the batch numbers assigned by the manufacturer, we assign lot numbers to each product. This allows any product to be traced back to the starting materials
Shelf Life and “Best Before Date”
Each sample we draw and retain from shipments is checked periodically for stability. Samples are tested for aerobic microorganisms, mold, yeast, and coliforms. Stability is dependent upon a host of factors: whether it is an herb, a concentrated powder, or a pill or tablet; the nature of the individual ingredients and their rates of oxidation; the packaging and storage conditions, etc. All of these factors play a role in how stable and effective a product will be. Unlike pharmaceutical drugs, which have identified active ingredients that are used as a measurement of chemical stability which in turn determines efficacy, and therefore “shelf-life,” it is much more difficult to establish a product life for traditional Chinese medicines. Our manufacturers have conducted stability tests, consulted the guidelines in the Pharmacopoeia and other references, and looked closely at the oxidation rates of individual ingredients to establish a reasonable shelf life for each product.
Finest Traditional Chinese Herbal Formulas
Ancient techniques
Modern standards
Yosef studying with Dr Hu ~ Beijing, China 1998
Yosef Pollack has studied, published and worked with many master herbalists during his 20 years of practice, providing formulas for many hundreds of patients for a variety of maladies. MAYWAY Herbals is of the highest caliber of herbs formulated for patients here in the West. The material above is for you to read assuring that you are receiving the finest quality of Traditional Chinese Herbal Formulas. Please contact us with any health concerns.
We now carry
Modern living places a variety of stresses on our bodies that can result in physical discomfort. We specialize in achieving natural, healthy relief from pain and discomfort using a variety of traditional Asian medical techniques.
According to Traditional Chinese Medicine, physical problems result from blockages in the flow of energy or “chi” in the body. We use special techniques to release these blockages, helping eliminate the causes of pain and discomfort.
Please explore this site to learn more about our treatment techniques, appointments, and rates. Call or email us with questions about any aspect of our services or to schedule an appointment.
708.445.2000
1105 Holley Ct. Oak Park IL 60301
