摘要
在对欧盟GMP和相关验证指南深入理解的基础上,对过滤、洗涤、干燥机的验证过程进行研究,即通过对"三合一"四项确认的学习和实践结果定性及定量分析,使其达到欧盟的设备验证要求。
By understanding the EU-GMP and relevant guideline further and studying the validation process of the filtration and washing drying machine,i.s.Qualitative and quantitative analysis the results of qualification process and make it meet the requirement of the EU-GMP.
