主文件的修订按变更控制程序进行管理。
Modifications to M-aster Documents are managed through Change Control.
您是否建立了符合药品GMP（2010年修订）要求且很严格的变更控制程序？
Do you have a strict change control procedure, which follows the requirements of the GMP Guidelines (revised in 2010)?
对于同用户的契约关系来说，在构建中较早地制定严格的变更控制程序也许是必须的。
For contractual relationships with users, it may be necessary to institute strict change control procedures early in Construction.
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