Statistical quality control process for traditional Chinese medicine

Siu Keung Tse, Jang Yang Chang, Wei Lun Su, Shein Chung Chow, Chao Hsiung, Qingshu Lu

Research output: Contribution to journalArticlepeer-review

19 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)861-874
Number of pages14
JournalJournal of Biopharmaceutical Statistics
Issue number6
Publication statusPublished - Dec 2006
Externally publishedYes


  • Acceptance criteria
  • Consistency index
  • Sampling plan
  • Test procedure

ASJC Scopus subject areas

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)


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