Statistical quality control process for traditional Chinese medicine.
Journal Article (Journal Article)
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.
Full Text
Duke Authors
Cited Authors
- Tse, S-K; Chang, J-Y; Su, W-L; Chow, S-C; Hsiung, C; Lu, Q
Published Date
- 2006
Published In
Volume / Issue
- 16 / 6
Start / End Page
- 861 - 874
PubMed ID
- 17146984
International Standard Serial Number (ISSN)
- 1054-3406
Digital Object Identifier (DOI)
- 10.1080/10543400600808047
Language
- eng
Conference Location
- England