HPLC积分方法设定应该达到准确、科学、稳定的积分效果，如果达不到科学积分，可进行调整积分参数或手动积分，但两者均需要进行科学的论述和说明，手动积分应该限制并有批准授权程序进行，同时在第二人数据审核时进行涵盖包括审计追踪的审核。

13. Peak integration

13.1 Peak areas in chromatograms should be accurately and consistently integrated in a scientifically sound manner.

13.2 Where possible, HPLC and GC instruments should be interfaced with computerized chromatographic data-capturing and processing systems that are capable of applying the integration parameters set, automatically and consistently.

13.3 To facilitate the accurate integration of chromatographic peaks, it is preferable that all of the peaks are fully separated. However, when quantitative data are to be obtained from unresolved peaks, the laboratory should have clear policies as to how such peaks should be integrated. This should include a description of the type of integration to be used, with a justification for its use, including, for example:

■ tangential skim;

■ exponential skim;

■ exponential curve fitting;

■ straight line skim;

■ front peak skim;

■ rear peak skim;

■ peak-to-valley ratio; and

■ valley height ratio.

13.4 Validated methods, specified chromatographic conditions and good chromatography practices should facilitate obtaining symmetrical peaks. Where atypical peak shapes are observed, these should be investigated and appropriate action taken.

1 3.5 Where manual integration has to be done, authorized procedures should be followed. Records should be maintained and include the authorization and justification for manual integration.

13.6 Using a procedure to integrate peak height or area by manually setting the baseline using chromatographic software should only be allowed in exceptional cases. Only trained, experienced users should be granted privileges to do so. Records and justification should be given when this procedure is followed.

13.7 Where smoothing is applied, the type of “filter” used and the extent of smoothing should be justified.

可参考WHO《良好色谱规范》“12.3 最好由经过授权的人员在色谱系统中创建并保存检验方法。从已保存方法中选择分析用方法时不应对方法进行修改，除非经由授权人员批准用于预期用途。”的要求。

这个基本是普遍操作了。我们公司对于HPLC积分方法，不但需要锁定，而且对于积分人员的权限也会有一定的要求，并不是所有人员都可以去积分。我们一般是实验人员只有建序列和进样的权限，积分的权限在她的主管。

这个数据数据完整性的一个环节吧，保证你数据的真实性，不会有法规规定的这么细。

这是数据完整性的典型问题。

答案是，应受控。包括手动积分。ECA数据管理和数据完整性也提到了这个问题。