Analysis on the Defects of Drug GMP Certification Inspection in Henan Province and Recommendations after the Implementation of Newly Revised Drug Administration Law
JIN Jian-wen, DANG Ming-an, XIE Zhi-li
Henan Province Food and Drug Evaluation and Inspection Center, Zhengzhou 450000, China
Abstract：OBJECTIVE To discover the common deficiency in GMP certification existing in pharmaceutical enterprises of Henan Province, analyze the existing main risk point, offer some measures and suggestions and provide reference for implementing the newly revised Drug Administration Law. METHODS All defective items found in the 210 on-site inspection reports for GMP certification of pharmaceutical enterprises were statistically analyzed. RESULTS AND CONCLUSION After the implementation of the newly revised Drug Administration Law, drug manufacturers need to pay attention to the problems in quality control and quality assurance, document management, equipment and other aspects, and make continuous improvement and promotion accordingly. Drug regulatory departments enhance supervision by changing the supervision mode and increasing the inspection frequency and prevent the occurrence of drug safety accidents.
金建闻, 党明安, 谢芝丽. 河南省药品GMP认证缺陷分析及新修订《药品管理法》实施后的建议[J]. 中国药学杂志, 2021, 56(2): 162-167.
JIN Jian-wen, DANG Ming-an, XIE Zhi-li. Analysis on the Defects of Drug GMP Certification Inspection in Henan Province and Recommendations after the Implementation of Newly Revised Drug Administration Law. Chinese Pharmaceutical Journal, 2021, 56(2): 162-167.
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