ISO 14644版本总结

ISO 14644版本总结

摘要

ISO 14644版本总结最新版本 ISO 14644-1和-2已经发布了不少洁净室等级以及监测指导方针的更改。这个文件强调了新版 ISO 14644-1中的重要更改，以及可能对制药欧洲GMP 附录1 & FDA无菌制程指导方针的影响

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