A copy of the current GMP certificate (Annex 3) orreference to the EudraGMP database should be included, if available. 1.3在生产厂地进行的其他生产活动 Any other manufacturing activities carried out on the site -如果有的话,对生产厂地内的非药品生产活动进行描述。 description of non-...
A copy of current GMP certificate (Appendix 3) or reference to the EudraGMP database should be included, if available. 列出过去5年的现场GMP检查清单,包括日期和进行检验的药政机构的名 称/国家。如果有,应当提供现行的GMP证书(附件3)或引用欧洲GMP 数据库中的副本。 Any other manufacturing activities ...
View Abbott Laboratories's WHO GMP Certification details related to GMP Quality Systems on PharmaCompass.com
1.2. In recent years, the number of observations made regarding the integrity of data, documentation and record management practices during inspections of good manufacturing practice (GMP), good clinical practice (GCP) and good laboratory practice ...
审计追踪是含有 GMP 记录创建、修改或删除相关动作信息的元数据表。审计追踪提供生命周期详细情况的安全记录,如电子或纸质记录中信息的创建、增加、删除或修改,而不会妨碍或改写原始记录。审计追踪有利于重建此类与记录(无论使用何种介质)有关事件的历史,包括动作的“何人何事何时及因何”。 data governance.数据管理...
近年,在 GMP、GCP 和 GLP 检查中,数据完整性、文件记录管理规范性方面的缺陷数量大大上升。可能的原因大致包括(1)太过依赖人员操作,(2)使用了未进行恰当管理和验证的计算机化系统,以及(3)未充分审核和管理原始数据与记录。 1.3. Quality risk management (QRM), control strategies and sound scientific principles...
19、GMP inspections of the site within the last five years; including dates and name/country of the competent authority having performed the inspection. A copy of the current GMP certificate (Annex 3) or reference to the EudraGMP database should be included, if available.1.3 在生产厂地进行的...