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


  • eng

Conference Location

  • England