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。
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？
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？
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