Research on current situation,difficulties and specific suggestions of certification of the new version of GMP
Author(s): YAN Jian-zhou, SHAO Rong
Pages: 311-314,318
Year: 2014 Issue: 6
Journal: Qilu Pharmaceutical Affairs
Keyword: New version of GMP; Full-time GMP inspector; Market withdrawal mechanism;
Abstract: This paper analyzed the current situation of GMP certification,concluding the difficulties and problems in certification process in terms of certification concepts,costs,financial sources and related mechanisms,providing specific suggestions on the basis of representative provinces such as Shandong. Suggested that we should change the enterprises′ negative attitude toward GMP certifica-tion,accelerate certification process;broaden financial sources to relieve the fund pressure of enterprises;set up full-time GMP inspec-tors pool to improve the efficiency of certification;perfect market withdrawal mechanism to eliminate the worries of enterprises.
Pages: 311-314,318
Year: 2014 Issue: 6
Journal: Qilu Pharmaceutical Affairs
Keyword: New version of GMP; Full-time GMP inspector; Market withdrawal mechanism;
Abstract: This paper analyzed the current situation of GMP certification,concluding the difficulties and problems in certification process in terms of certification concepts,costs,financial sources and related mechanisms,providing specific suggestions on the basis of representative provinces such as Shandong. Suggested that we should change the enterprises′ negative attitude toward GMP certifica-tion,accelerate certification process;broaden financial sources to relieve the fund pressure of enterprises;set up full-time GMP inspec-tors pool to improve the efficiency of certification;perfect market withdrawal mechanism to eliminate the worries of enterprises.
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