我们目前没有锁定积分方法，写入SOP中，但是规定了积分参数的调整需要第二级权限来进行调整，平时尽量使用之前已设置好的处理方法文件。对于手动积分的要求，有单独建立SOP，手动积分必须说明原因。

应尽可能做到自动积分。但是对于一些生物制品的色谱方法。往往无法依赖自动积分。因此需要建立手动积分方法，但是需要确定手动积分的要求以及相应人员的复核和批准。包括审计追踪的。一些积分方法的轻微改变及可以产生0.5%-2的差异。还是需要对积分方法进行严格管理。

供参考。

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。

法规和指南中并未明确规定必须锁定积分方法，锁定积分方法虽然规避了人员手动积分或者篡改色谱数据的风险，也同时给企业带来了很多的效率的降低，应该基于各企业的内部控制、色谱方法的稳定性、审核体系的完整性等；WHO色谱指南中相关的要求如下，可进行参考。

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.