摘要
目的通过对以品种为单元的药品GMP实施模式与参数放行模式的对比分析,探讨该模式与国际先进模式的异同,及其发展趋势。方法采用对比分析法,对两类模式的实质内涵、覆盖品种等方面的异同点进行比较分析。结果与结论以品种为单元的药品GMP实施模式是药品生产参数放行的初始阶段,随着该模式的发展完善,终将实现所有品种生产均按参数放行。
Objective To research the similarities and differences between the specie-specific patterns with the advanced pattern and the trend of specie-specific patterns through the comparison analysis on the two patterns.Methods By the method of comparative analysis,study the similarities and differences between the specie-specific patterns with the parametric release on the connotation and the covering surface.Results and Conclusion The pharmaceutical GMP model on specie-specific patterns is the initial stage of parametric release.With the development of the specie-specific patterns,the implementation of all varieties of drugs should conform to the parametric release.
出处
《中国药事》
CAS
2010年第4期358-360,共3页
Chinese Pharmaceutical Affairs
关键词
药品GMP
以品种为单元
参数放行
pharmaceutical GMP
specie-specific patterns
parametric release
