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Are those critical parameters and their control ranges defined by risk assessment and included in the VMP (Validation Master Plan)?
那些关键参数及其控制范围是通过风险评估确定的吗？它们包含在验证总计划中了吗？
The key elements of a validation program should be clearly defined and documented in a validation master plan (VMP) or equivalent documents.
验证计划的关键组成部分应该明确定义并在验证主计划（VMP）或类似文件中写明。
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