Quality Assurance and Control for Plum Flower Products

Quality Assurance and Control for Plum Flower Products

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.

Quality Testing

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.

Third 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.

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. Additionally, 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.

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.

Mayway's Heavy metals testing limits lower than U.S. Pharmacopoeia limits

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.

Plum Flower® Premium Quality herbs

All Plum Flower® Premium Quality herbs are the officially validated species as listed in the Chinese Pharmacopoeia or other government accepted Materia Medicas. Herbs are sourced from their indigenous regions, ensuring geo-authenticity and quality, and usually come to us direct from the growers and harvesting co–ops. Upon receipt, each herb is inspected to ensure correct species identification, proper maturity, and quality.

Inspection is conducted by highly trained staff using macroscopic, microscopic, and sometimes thin layer chromatography (TLC) means to confirm species. Herbs are tested also for sulfur dioxide residues and for certain pesticide residues to ensure safety and quality. Plum Flower® Premium Quality herbs are processed according to Official PRC Pharmacopoeia and Materia Medica methods to reduce toxicity, modify herb characteristics, and to enhance efficacy. Further processing may include cutting (by machine or hand), steaming, and drying. Proprietary methods have been developed to avoid the typical manner of preserving herbs with sulfur dioxide fumigation and other preservatives. The processed and prepared herbs are vacuum packaged and nitrogen injected, either in between the double bags, or into the bag if singly bagged, to naturally preserve freshness.Finished batches of Plum Flower® Premium Quality herbs are tested for various quality assurance parameters including moisture content, heavy metals (lead, arsenic, mercury, cadmium) and microbial contamination. They are also tested for certain pesticide residues. These tests are performed on every batch of finished product. 

The above information is directly taken from Mayway.com.