If the review frequency for the data is specified in CGMP regulations, adhere to that frequency for the audit trail review. For example, § 211.188(b) requires review after each significant step in manufacture, processing, packing, or holding, and § 211.22 requires data review before batch release. In these cases, you would apply the same review frequency for the audit trail.

如果CGMP规定了数据审核频率，请按照该频率进行审计追踪审核。例如，§211.188(b) 要求在生产、加工、包装或贮存的每个重要步骤之后进行审核, §211.22 要求在批放行之前进行数据审核。在这些情况下, 需要对审核跟踪使用相同的审核频率。

If the review frequency for the data is not specified in CGMP regulations, you should determine the review frequency for the audit trail using knowledge of your processes and risk assessment tools. The risk assessment should include evaluation of data criticality, control mechanisms, and impact on product quality.13

如果CGMP法规中没有规定数据的审核频率, 则应应用工艺知识和风险评估工具来确定审计追踪的审核频率。风险评估应包括对数据关键性、控制机制，以及对产品质量的影响的评价。


Your approach to audit trail review and the frequency with which you conduct it should ensure that CGMP requirements are met, appropriate controls are implemented, and the reliability of the review is proven.

审计追踪审核的方法以及执行的频率应确保符合CGMP要求, 实施适当的控制, 并证明审核的可靠性。



See the audit trail definition in 1.c. above for further information on audit trails.

有关审计追踪的更多信息, 请参见上文 1. c. 中的审计追踪定义。