MHRA GMP数据完整性老话新谈：第三部分

MHRA GMP数据完整性老话新谈：第三部分  
Good Manufacturing Practice (GMP) data integrity: a new look at an old topic, part 3
MHRA GMP数据完整性老话新谈：第三部分
David Churchward, 27 August 2015 — Compliance matters, Good manufacturing practice
2015年8月27日，DAVID CHURCHWARD
Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. A robust data governance approach will ensure that data is complete, consistent and accurate, irrespective of the format in which data is generated, used or retained.
数据完整性在药品质量体系中是一个基本的问题，它确保药品具备所需的品质。坚实的数据管理方法可以确保数据完整、一致和准确，而不论数据产生形式如何，如何使用或保存。
This is the last in a series of 3 blogs exploring the impact of organisational behaviour and procedures on reliable, consistent and accurate data in medicines manufacture. The first blog looked at the impact of organisational behaviour and the second blog discussed ways in which systems can be designed to assure data quality and integrity.
本博客是探索有组织的行为和程序对药品生产中数据可靠性、一致性和准确性影响的三篇系列博文中最后一篇。第一篇博文探讨了有组织行为的影响，第二篇博文讨论了确保数据质量和完整性的系统设计方法。
The final blog in this series will look at the recurring problem of ‘trial analysis’, and ways in which organisations within the supply chain can take steps to build confidence and reliance on each other’s data.
系列的最后一篇博文将讨论一再发生的“试针”问题，以及供应链内的组织可以采取何种措施来增加彼此数据的可信度和可靠信。

MHRA GMP数据完整性老话新谈：第三部分 - Julia - 成功是永远的追逐，追逐是永远的成功

Data governance is an integral part of the pharmaceutical quality system
数据管理是药品质量体系不可分割的一部分。
Trial (injections) and error 试针和错误
The use of ‘trial injections’ in chromatographic tests to verify stability of the analytical set-up is a recurrent theme reported as grounds for regulatory action. This practice is particularly concerning where the ‘trial injection’ is a product sample, whose results are then discarded or retained under a different file structure to other results. In these circumstances, data integrity is undermined, particularly if the result obtained from the trial injection failed to comply with specification. At the very least it asks serious questions regarding analyst understanding of data integrity, quality system design or managerial response to undesirable results.
已有不少报道说明，在色谱测试中进行“试针”来核对分析状态的稳定性是法规当局采取措施的原因。这种行为在“试针”的样品是正式产品，且其结果被抛弃或保存在与其它结果所不同的路径文件夹时尤其受到关注。在这种情况下，数据完整性的根本被破坏，尤其是试针所得的结果不符合质量标准的情况下。至少它质疑了化验员对数据完整性的理解，质量体系设计或管理方面对非预期结果的反应。
In cases where analyses run over an extended period, it may be understandable that the analyst would wish to verify that the analytical system is operating as expected before committing the full system suitability and sample set. Where there is management agreement that verification of analytical system stability is required prior to system suitability checks, there are some basic considerations which can address the data integrity concerns.
如果分析过程需要运行一段较长时间，则可以理解化验员可能希望要确认其分析系统在实施全面系统稳定性和样品序列前可以如预期要求运行。如果管理人员同意在系统适用性检查之前对分析系统稳定性进行核查的话，应该有一些基本的考虑来解除对数据完整性的担忧。
The practice needs to be consistent with the company’s data governance system. The system stability check must be proceduralised as part of the approved method or standard operating procedure (SOP), with corresponding guidance on the assessment of the results, and all data (including system stability check samples) should be reported. Importantly, a sample of the product batch under test should not be used for the system stability check. An independent, well-characterised sample or standard will fulfil the analytical requirement without raising data integrity concerns relating to ‘testing into compliance’. A robust laboratory data governance approach will also include periodic reconciliation of analytical sample runs, to confirm that there are no concealed trial injections or modified sample runs.
操作需要与公司的数据管理体系要一致。系统适用性检查必须制订作为批准的方法或标准操作程序（SOP）的一部分，还要包括对结果评估的相应指南，所有数据（包括系统适用性检查样品）均要报告。重要的一点是，要测试的产品批的样品不能用于系统适用性检查。可以采用一个独立的、已知特性的样品，或标准品来满足分析的要求，而不会引起数据完整性关于“符合性导向测试（测试直到合格）”的担心。一个稳定的化验室数据管理方法也应包括对分析样品运行数量的定期平衡核查，以确认并没有隐藏的试针或修改过的样品分析。
Supply chain 供应链
In the first blog of this series I described how omitting one aspect of the data lifecycle weakens the effectiveness of other governance measures. The same principle applies to the supply chain. A failure at one site weakens all sites downstream in the chain.
在本系列的第一篇博文中，我描述了忽略数据生命周期的一个方面会如何削弱其它管理措施的有效性。相同的原则也适用于供应链。在一个场所的失败会削弱供应链中所有下游场所的数据完整性。
To keep the supply chain moving, organisations need to place reliance on summary reports – batch records, analytical data, validation reports etc, especially in relation to outsourced services. It is therefore important to use supplier audits as an opportunity to build confidence in these summaries provided on a routine basis. What is the contractors organisational culture and maturity relating to data governance? What systems do they have to ensure data integrity?
为了保持供应链的运转，各组织需要能依赖总结报告---批记录、分析数据、验证报告等，特别是与外包服务相关的报告。因此使用供应商审计来建立其对这些定期提供的总结报告的信心是很重要的。合同外包单位的数据管理文化和成熟度是怎样的？他们采用了什么体系来确保数据完整性？
Conclusion 结论
Data governance is an integral part of the pharmaceutical quality system, with effort and resource being balanced in accordance with other risks to product quality.  As such, manufacturers and analytical laboratories are not expected to implement a forensic approach to data checking on a routine basis, but instead design and operate a system which provides an acceptable state of control based on data criticality and inherent risk.
数据管理是药品质量体系不可分割的一部分，其投入与资源和产品质量其它风险一样是需要平衡考虑的。因此，并不期望生产商和分析化验室定期对数据检查的方式可提供经得起犯罪庭审一样的证据，只是要求其设计和运作一个系统的方式能提供可接受的声明，表明其控制是基于数据关键程度和内在风险水平的。
Data integrity requirements apply equally to manual (paper) and electronic data. Reverting from computerised to paper-based systems will not in itself remove the need for data integrity controls. The implementation of effective behavioural, procedural and technical steps based on a clear understanding of risk will ensure that the system will encourage the right behaviours, improve compliance, and provide greater assurance of product quality.
数据完整性要求平等适用于手动（纸质）和电子数据。从计算机化系统返回到纸质系统并不会自动消除对数据完整性控制的要求。基于对风险的清楚了解，实施有效的行为规定、程序化和技术步骤将能确保系统会鼓励正确的行为、提高符合性，并且提供更好的产品质量保证。
MHRA has published more detailed guidance on data integrity expectations, which builds on the behavioural and procedural topics covered in this series of blogs.
MHRA已发布了关于数据完整性期望的更详细的指南，它是建立在本博客系列所涵盖的行为和程序方面主题上的。
http://zhuyujiao1972.blog.163.com/blog/static/98694727201573185210379/