对GMP实施成果及药品认证风险的理性思考

目的全面实施GMP是我国医药发展史上的一个里程碑。GMP认证检查应确立发展理念,拓展思路,更新方式,规范行为。方法论述了通过实施GMP,我国药品生产企业的生产环境和生产条件发生的根本性转变,制药工业总体水平显著提高。结果实践证明,GMP是行之有效的科学化、系统性的管理手段。结论面对药品安全风险的高发期,需要以积极而理性的社会心态,正视目前存在的质量隐患,强化认证跟踪检查,建立药品安全监管的长效机制。

Rational Thinking on Achievement of Implementation of GMP and Risks of Drugs Certification

Objective Fully implementing GMP is a milestone in the development of Chinese medicine industry. GMP certification examination should be established by developing ideas and ways to update and standardize the behavior. Methods By implementing GMP, revolutionary changes have taken place on the production environment and condition of Chinese drug companies and the overall level of the pharmaceutical industry have been greatly elevated. Results Practice has proved that GMP was an effective, scientific and systematic managerial tool. Conclusions Facing the high risk of the break of drug safety problem, we need to take positive and reasonable social attitude, envisage the existing quality problem, strengthen the authentication＇s tracking inspection, and set up the long-term mechanism of the supervision and management of drug safety.