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性别保密
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发表于 2014-8-22 16:13:28
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ISPE里面有提及,我摘了几段
The Maintenance Good Practice approach to spare parts and materials application is to establish criteria for identifying spare parts and materials as "like for like."
The Maintenance Unit should develop a procedure to determine if spare parts and materials are "like for like." This procedure should be approved by the Quality Unit. When parts or materials are deemed "like for like," they can be installed as identical or functionally equivalent and do not require further documentation, beyond noting the installation on a WO.
If parts or materials are deemed not to be "like for like," this constitutes a change that should be documented through the established change control process for cGMP systems or equipment. Testing and re-qualification requirements should be established in advance of any part application. Appropriate testing should be conducted to provide assurance that the equipment is working properly and is suitable for its intended use.
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