How are the data integrity expectations (ALCOA) for the pharmaceutical industry prescribed in the existing EU GMP relating to active substances and dosage forms published in Eudralex volume 4?
在Eudralex第4卷公布的与活性物质和剂型有关的现有欧盟GMP中，如何规定制药业的数据完整性期望（ALCOA）？
1 回答
The main regulatory expectation for data integrity is to comply with the requirement of ALCOA principles. The table below provide for each ALCOA principle the link to EU GMP references (Part I, Part II and Annex 11):
对数据完整性的主要监管期望是遵守ALCOA原则的要求。下表为每项ALCOA原则提供了与欧盟GMP参考文献（第一部分、第二部分和附件11）的链接。
