行业认证
Good Manufacturing Practice (GMP) Internal Auditor
药品生产质量管理规范（GMP）内审员
面向药品生产企业QA/QC岗位，培训GMP条款、偏差处理、变更控制与自检审核方法。
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A sample question · with answer and explanation
某片剂车间进行GMP自检时发现，压片机岗位操作记录中部分批次的片重差异数据由操作工事后凭记忆补填，自检组长判定该缺陷属于数据可靠性问题，其核心理由应是该行为违反了记录填写的哪项基本要求
AI explanation知识点：GMP对记录填写及时性的要求。正确项：生产记录应在操作过程中即时填写，事后凭记忆补填无法保证数据真实、准确，属于数据可靠性缺陷。错误项：签名要求针对的是代签问题，与本场景补填无直接对应；笔色要求是记录载体规范，不是本缺陷核心；记录存放地点要求与事后补填无关。
About the Good Manufacturing Practice (GMP) Internal Auditor exam
- Issuing body行业协会或第三方培训机构
- Choose your level不分级
- Question bank300 questions online (growing)
- Practice modesSequential practice, mock exam, flash review, mistake drills
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