USP Ingredient Verified Mark imparts creditability to TCM products and offers Hong Kong a solution to address the quality issues of traditional Chinese medicines
Hong Kong, 13 August 2009 – A locally-developed Chinese medicinal ingredient, freeze-dried coriolus versicolor extract (commonly known as Yunzhi extract), has successfully passed the stringent verification processes of the United States Pharmacopeia (USP). It is the first and only botanical extract and dietary ingredient to acquire the USP Ingredient Verified Mark in Hong Kong.
The USP verification signifies that the ingredient’s manufacturing procedures and quality control are consistent with the standard operating procedures, and the manufacturing system and monitoring procedures are in compliance to International ICH GMP (Good Manufacturing Practice) guidelines. As an independent, not-for-profit public health organization, USP sets standards for prescription and over-the-counter medicine which are enforced by United States Food and Drug Administration. USP also sets standards for food ingredients and dietary supplements.
USP’s Verification Program verifies the ingredients used in the manufacture of dietary supplement products. Ingredients that pass USP's rigorous verification processes are awarded use of the USP Ingredient Verified Mark to display on containers of the verified ingredient. The mark recognizes the ingredients of consistent quality for use in the supplements they manufacture.
By acquiring the internationally recognized USP Ingredient Verified Mark for its TCM product, a company is much better positioned to gain international credibility when it sells its product in the international market.
Dr. Albert Wong, Founding President, Modernized Chinese Medicine International Association, said, “Currently, there is no internationally consensus for safety and quality standards for traditional Chinese medicines. That is why almost 3 years ago MCMIA (Modernized Chinese Medicine International Association) entered into an agreement with USP to introduce the USP Ingredient Verification Program to the Greater China Region to help TCM companies in the Region to get USP accreditation for the safety and quality of their products.”
“We are very pleased to see a HK based company becomes the first one to earn this honor. We hope it will take full advantage of the credibility this Mark imparts to the product so as to facilitate its entry into the international market. We also look forward to other companies to emulate this success and follow this path to internationalize their own TCM products,” added Dr. Wong.
Dr. John Hu, General Manager, US Pharmacopoeia R&D (Shanghai) Co. Ltd, said, “One of the major challenges for herbal, TCM and supplements industry is to demonstrate a stringent process to control the quality is in place per international standard and the ingredients that consistently meet the specifications are used in the product.”
“USP, as an official public standards setting authority conducts verification programs for dietary supplement ingredients and products and pharmaceutical ingredients. These programs involve manufacturing process GMP audit, independent testing and review to verify ingredient and product integrity, purity, and potency for manufacturers who choose to participate,” said Dr. Hu.
Mr. Abraham Chan, Chairman of PuraPharm Group of Companies said, “We applaud USP for trying to help consumers identify high-quality dietary supplements. As a manufacturer of Chinese medicinal ingredients and products, our ultimate goal is to provide consumers with safe and high quality products that they can trust and use with confidence. Our voluntary participation in the USP quality verification demonstrates our commitments.”
Products and ingredients that pass all strict USP verification requirements are awarded the distinctive USP Verified Mark. The unique process requests manufactures to carry out the manufacture of the ingredient. USP also accesses whether the manufacturing system and monitoring procedures are up to the GMP standard.
Samples are tested to confirm the ingredients meet the requirements for acceptable limits of contamination; as well as its purity. USP also reviews chemical and manufacturing control document including standard operating procedures, management processes, validation protocols and report, as well as operating and batch production records.
Throughout the entire verification process of the freeze-dried Yunzhi extract, Prof. Lau, Expert of Molecular Chinese Medicine and Cytokine Biology, has led a team of analytical chemists and biomedical scientists to analyze the chemical compositions and investigated biological effects of the medicinal herbs. The platform technology used include high performance liquid chromatography, gas chromatography-mass spectrometry, genomics profiling by genechips, validation of biological effects by gene amplifying techniques (PCR assays), and cell signaling and immunological studies.
Prof. Lau said, “the complexity of Chinese medicine formulae is an enormous technological challenge to the research and quality assurance/control of herbal products.” Apart from the chemical method conventionally used, his team will continue to develop efficient and practical methodologies for chemical analysis and validation of biological effects of yunzhi and related herbs.
Yunzhi extract is widely used as an adjunct to conventional serious illnesses treatments including surgery, chemotherapy and radiotherapy. Clinically it helps to stimulate the immune system and reduces the undesirable side effects of the radiation and chemotherapy and increases the effectiveness of the conventional therapies. It also improves the quality of life as well as increases the survival time.
Since its discovery in 1971, over 350 scientific and clinical studies have been published demonstrating Yunzhi’s potential benefits to a variety of diseases, especially serious illnesses. The latest research by the Hong Kong Chinese University on integrated TCM serious illnesses treatment involving 3,063 patients suffering from different types of serious illnesses further illustrates the effectiveness of Yunzhi. A total of 1,540 patients took Yunzhi during their serious illnesses treatments; the rest only received the traditional radiology and chemotherapy. The results showed that the five year survival rate of serious illnesses patients taking Yunzhi is 8% higher than those who did not take any Yunzhi.
In Japan, Yunzhi has been approved as a serious illnesses adjunct by the Ministry of Health and Welfare, and is widely prescribed to serious illnesses patients. However, the benefits of Yunzhi in serious illnesses treatments are not fully appreciated in Hong Kong.
Dr. Bernard Chan, M.D. and the co-author of the bestselling book “Yin and Yang of Serious illnesses” said, “The challenge of traditional Chinese medicine for Western practitioners is to ensure the quality and stability of the ingredients for safe consumption in a Western context. USP verification of TCM ingredient is the best solution to address the quality issue of TCM that Hong Kong is facing.”
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