title: Statistical quality control process for traditional Chinese medicine.
abstract: The statistical quality control process on raw materials and/or the final product of traditional Chinese medicine (TCM) is examined. We develop a statistical quality control (QC) method to assess a proposed consistency index of raw materials from different sources and/or final products manufactured at different sites. The idea is to construct a 95% confidence interval for a proposed consistency index under a sampling plan. If the constructed 95% confidence lower limit is greater than a prespecified QC lower limit, then we claim that the raw material or final products have passed the QC and hence can be released for further processing or use; otherwise, the raw materials and/or final product should be rejected. For a given component (the most active component if possible), a sampling plan is derived to ensure that there is a desired probability for establishing consistency between sites when there is truly no difference in raw materials or final products between sites. An example concerning the development of a TCM is presented to illustrate the proposed statistical QC method for assessing consistency in raw materials from two sites.
authors.affiliation: Department of Management Sciences, City University of Hong Kong, Hong Kong, China.
authors.forename: Siu-Keung
authors.initials: SK
authors.lastname: Tse
authors.forename: Jang-Yang
authors.initials: JY
authors.lastname: Chang
authors.forename: Wei-Lun
authors.initials: WL
authors.lastname: Su
authors.forename: Shein-Chung
authors.initials: SC
authors.lastname: Chow
authors.forename: Chao
authors.initials: C
authors.lastname: Hsiung
authors.forename: Qingshu
authors.initials: Q
authors.lastname: Lu
mesh_terms: D000465:Algorithms; D003627:Data Interpretation, Statistical; D004365:Drugs, Chinese Herbal / Q000592:standards*; D008516:Medicine, Chinese Traditional / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size
chemical_list: D004365:Drugs, Chinese Herbal