中小型制药企业实施新版GMP的研究

Research on the New Edition of GMP Implemented in the Minor Pharmaceutical Enterprises

通过对比98版GMP和新版GMP的一些变化,并结合中小型制药企业的实际情况来找出更好的应对这些变化的有力措施。结果和结论:跟大型制药企业相比,中小型制药企业在实施新版GMP上有些不同的原则和做法,当中小型制药企业遵循这些时,成功进行新版GMP的改革还是有希望的。

Compare the GMP （revised in 1998） and GMP （revised in 2010） to find out the differences between the two specifications, then combine the physical truth in the minor pharmaceutical enterprises to seek out effective measures to deal with the changes.Results and Conclusions：Compared to large-scale pharmaceutical enterprises, minor pharmaceutical enterprises have different principles and methods to pass through GMP certification, and if minor pharmaceutical enterprises follow these principles and methods, success in reform of GMP （new edition） is hopeful.