Quality Assurance and Control
Quality Assurance and Control
Scientific testing and data serve to confirm that a product meets safety and other quality parameters. However, we believe that the essence of Chinese medicine, its power, is not something that is easily quantified. The manufacturing of a traditional Chinese medicine is not just a scientific process, but also an art resulting from an understanding of the nature of herbs and an experienced hand. While our products are made in carefully controlled GMP environments, much of the character and quality of the final product is based on a set of human choices: the quality of starting materials, the large and small decisions made during processing, and a commitment to quality in every aspect. The results of these choices are not always quantifiable, but the care and attention to detail in their creation can be experienced in the appearance, smell, taste, and effects of any of our products.
Good Manufacturing Practices (GMP)
Good Manufacturing Practices (GMP) helps ensure the quality and safety of products, traceability of ingredients, and transparency of the manufacturing process among other things. GMP certification means that the site and methods employed in production have been subject to a thorough quality control investigation by a government agency or qualified third party organization 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.
At each of the GMP certified facilities of our manufacturing partners is an in-house lab where extensive quality control analysis is performed. Testing ranges from basic organoleptic and microscopy to higher-level analytical techniques including High Performance Thin Layer Chromotography (HP-TLC) and High Performance Liquid Chromatography (HPLC) to confirm identification, ensure potency and to test for active constituents when necessary.
All raw materials are inspected and species confirmed before being processed or used. Physical tests such as dissolution time and moisture content, chemical tests for pesticides and heavy metals, and microbiological tests are performed on every batch of finished product. Following extensive in-house testing, products are randomly selected and tested at third party labs to confirm and ensure that quality and safety standards have been met.
In–House Quality Control
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 with past lots for consistency. Herbs are inspected using sensory protocols, and confirmed against standard references if necessary to verify quality and species.
Random products are sampled and sent to a third party laboratory for testing to confirm that they meet our specifications. One or more samples of every batch of product are retained on site.
Shelf Life and “Best Before Date”
Shelf life is the length of time that products are given before they are considered unsuitable for sale, use, or consumption. Mayway generally uses a best before date for its prepared products. We do not have “Best Before” dates on our herbs and herb powders.
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. The FDA final GMP rule for dietary supplements does not require the establishment of product expiration dates. Any expiration date placed on a product label must be supported by data, reserve samples must be maintained for one year past the shelf-life date, and dating claims must be tested by either accelerated or long-term studies. Mayway does not have stability testing data and does not make claims as to the shelf life of the herbs and herb powders it sells. Subsequently, we do not provide expiration or “Best Before” dates for these products.
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.
3rd Party Laboratory Testing
Following extensive in–house testing at the manufacturing site, heavy metal testing is routinely 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 are also conducted at third party labs.
Testing Standards and Limits
Each Mayway product has an individual product specification that outlines basic product requirements including ingredients, processing method, and quality control information. Quality control information includes applicable testing requirements and limit standards for that product.
Tests required always include microbial load, heavy metals, and certain pesticides, and may also include additional physical and chemical tests such as testing for moisture content, active ingredients or specific chemical markers when applicable, etc. Certificates of Analysis report the results of testing, and attest to the product being within our specifications. Certificates of Analysis are available for every Mayway product except for some external use products and individual grocery items.
Product and Ingredient Traceability
In addition to batch numbers assigned by the manufacturer, we assign tracking numbers to each product. This allows any product to be traced back to the starting materials. The ingredients in any prescription made in the Mayway Herbal Dispensary can be traced back to its individual batch information.