缺陷严重程度分类的定义

缺陷严重程度分类的定义：

Critical：An observation is defined as“Critical”when any one or more of the following four conditions apply：

Any non-conformance or non-compliance that will or already has adversely affected product performance meeting specification，safety，therapeutic efficacy，or regulatory requirements。

Any non-conformance or non-compliance that if allowed to continue，may result in product rejection，field action，or serious regulatory action(e.g. Warning Letter or similar)

The observation is a repeat“Critical”or“Major”observation,or relates to failure to meet a commitment made to a regulatory authority。

The observation represents the complete absence of one or more quality system elements or system components necessary to meet regulatory

requirements.

Major:An observation is defined as“Major” when any one or more of the following two conditions apply：

Any non-conformance or non-compliance that may or may have adversely affected product performance meeting specification，safety，therapeutic efficacy，or regulatory requirements。

Any isolated non-compliance in not reporting or reporting late any required regulatory/health authority reports notifications.(Note:frequent

occurrences represent a “Critical”observation.)

Major:An observation is defined as“Minor” when it is isolated and will not adversely affect product performance meeting specification,safety,therapeutic efficacy,or regulatory requirements.

Other: An observation that represents suggestion or recommendation but does not represent deficiency or non-compliance and does not adversely impact product performance meeting specification. This condition may be expected to have no impact on regulatory authority action.

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