PIC/S指南<GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS 受GMP/GDP监管环境的数据管理和完整性良好规范>(PI 041-12018年11月30日 (Draft 3))中提到关于数据完整性的风险管理方法:

不是所有的数据都对药品质量和患者安全具有等同的重要性,应考虑数据影响了什么决定以及对药品质量或安全的影响:

• 如,当作出批放行决定时,用以确定符合关键质量属性的数据通常比仓库的清洁记录重要。

• 如,对于口服片剂,API含量数据一般要比脆碎度数据对药品质量和安全影响更大。

Not all data or processing steps have the same importance to product quality and patient safety. Risk management should be utilised to determine the importance of each data/processing step. An effective risk management approach to data governance will consider:

不是所有数据和处理步骤都对药品质量和患者安全具有等同的重要性。应使用风险管理来确定每个数据/处理步骤的重要性。对数据风险管理的有效方法应考虑:

• Data criticality (impact to decision making and product quality) and

  数据关键程度(对制定决定和产品质量的影响)以及

• Data risk (opportunity for data alteration and deletion, and likelihood of detection / visibility of changes by the manufacturer’s routine review processes).

  数据风险(数据篡改、删除的机会,以及日常审核程序可检测这些问题的可能性)

From this information, risk proportionate control measures can be implemented.

应实施与风险相当的控制措施。

Data criticality

数据关键程度

The decision that data influences may differ in importance and the impact of the data to a decision may also vary. Points to consider regarding data criticality include:

受数据影响的决策可能会在重要程度上有所有不同,数据对决策的影响度可能也不同。关于数据关键程度要考虑的要素包括:

Which decision does the data influence?

数据影响了什么决策?

For example: when making a batch release decision, data which determines compliance with critical quality attributes is normally of greater importance than warehouse cleaning records.

例如,当作出批放行决定时,用以确定符合关键质量属性的数据通常比仓库的清洁记录重要。

What is the impact of the data to product quality or safety?

数据对药品质量或安全有什么影响?

For example: for an oral tablet, API assay data is of generally greater impact to product quality and safety than tablet friability data.

例如,对于口服片剂,API含量数据一般要比脆碎度数据对药品质量和安全影响更大。

来源:公众号 GMP办公室