... GMP/EU GMP/ISO相关经验及知识 sterilization validation 灭菌验证 HVAC/clean room validation 空调系统、洁净室验证 ...
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灭菌确效( Sterilization validation ) 项次 项 目 结 果 重要度 59 灭菌确效主计画书( master plan) : - 范围( Scope ) 与项目 - 执行时机或频率 - 负责执行组...
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Reporting the Dailies of executed of Validation engineer to quality manager of all types of validations incl. process systems, cleaning, equipment, sterilization, clean room, computer systems.
向质量经理汇报日常的所有类别的验证,包括工艺系统、洁净、设备、灭菌、洁净室、计算机系统。
This is accomplished primarily by validation of the sterilization process or of the aseptic processing procedures.
这主要是通过灭菌工艺或者无菌操作程序的验证来完成。
The company shall establish documented procedure for the validation of sterilization process, which shall be earlier than the initial use.
公司对灭菌过程的确认建立文件化程序,灭菌过程确认应在最初使用前进行。
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