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Implementation status and barriers of good manufacturing practice (GMP) for Chinese patent medicine
He T.T.; Hu H.; Wang Y.T.
2015
Source PublicationAfrican Journal of Traditional, Complementary and Alternative Medicines
Volume12Issue:4Pages:56
Abstract

Background: Safety, quality and effectiveness of Chinese patent medicine (CPM) are highly relevant to the manufacturing process. However, the level of manufacturing practice (GMP) for CPM as implemented in China is less reported in literatures. Therefore, the aim of this paper was to reveal the implementation status of GMP for CPM in China, in terms of implementation principle, implementation content, industrial impacts, and implementation barriers from both macro and micro aspects. Methods: A comprehensive analysis was carried out with archival data and field work at CPM manufacturers. Results: Both implementation principle and content of GMP for CPM in China indicated a transformation from provision-oriented to human-oriented, leaving more flexible operation space to CPM manufacturers. However, poor manufacturing practices may still exist because the implementation of GMP in China is not strict enough to eliminate all the unqualified CPM manufacturers from market. Moreover, compared with international WHO GMP, there are barriers for implementing GMP for CPM, including main deficiencies in quality control management, cost of GMP renovation projects, lack of education and training, and lack of expertise. Conclusion: This paper found that the implementation of GMP for CPM still faced many barriers though GMP had generated some positive impacts on CPM manufacturing. Removal of implementation barriers could be considered, including strengthening personnel competence, improving the quality management system and enhancing the international communication with advanced GMP regulators. © 2015, African Ethnomedicines Network. All rights reserved.

KeywordChinese Patent Medicine Gmp Good Manufacturing Practice Quality Risk Management Traditional Chinese Medicine
DOI10.4314/ajtcam.v12i4.9
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaIntegrative & Complementary Medicine
WOS SubjectIntegrative & Complementary Medicine
WOS IDWOS:000359018100009
The Source to ArticleScopus
Scopus ID2-s2.0-84938598599
Fulltext Access
Citation statistics
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
AffiliationState Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
First Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
He T.T.,Hu H.,Wang Y.T.. Implementation status and barriers of good manufacturing practice (GMP) for Chinese patent medicine[J]. African Journal of Traditional, Complementary and Alternative Medicines, 2015, 12(4), 56.
APA He T.T.., Hu H.., & Wang Y.T. (2015). Implementation status and barriers of good manufacturing practice (GMP) for Chinese patent medicine. African Journal of Traditional, Complementary and Alternative Medicines, 12(4), 56.
MLA He T.T.,et al."Implementation status and barriers of good manufacturing practice (GMP) for Chinese patent medicine".African Journal of Traditional, Complementary and Alternative Medicines 12.4(2015):56.
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