Statistical quality control process for traditional Chinese medicine.
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.
Tse
Siu-Keung
SK
Department of Management Sciences, City University of Hong Kong, Hong Kong, China.
Chang
Jang-Yang
JY
Su
Wei-Lun
WL
Chow
Shein-Chung
SC
Hsiung
Chao
C
Lu
Qingshu
Q
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
D004365:Drugs, Chinese Herbal