Journal of Pharmaceutical Practice 2021;39(3):287-290

doi:10.12206/j.issn.1006-0111.202101010

GMP Defects in the field inspection for processed Chinese herbal medicine manufacturers in Anhui Province during 2014 to 2018

Pengjun YIN 1 ; Shigao HU 1

Affiliations

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Keywords

Processed Chinese herbal medicine; good manufacturing practice; inspection; defects

Country

China

Language

Chinese

Abstract

Objective To propose the improvement measures and suggestions for the better quality management of processed Chinese herbal medicine production and provide insights and solutions for the quality control of processed Chinese herbal medicine production. Methods A retrospective statistical analysis was used to analyze the serious defects and major defects found in 50 processed Chinese herbal medicine manufacturers that failed to pass GMP certification in Anhui province from 2014 to 2018. Results The main problems found in processed Chinese herbal medicine manufacturers that failed to pass GMP certification were the low law consciousness of the legal representative or responsibility person, poor performance of key personnel, untraceable original data of the production records or testing, orderless material managements, ineffective operation of the manufacturing management system or quality control system. Conclusion It is recommended that processed Chinese herbal medicine manufacturers should enhance legal awareness, build good faith, pay attention to personnel training and GMP compliance. The regulatory authority should exercise the professionalism to ensure the quality and reliability of processed Chinese herbal medicines.