Compliance Gap Analysis 合规性差异分析
Our experienced GMP consultant will conduct a gap analysis against FDA cGMP, EU GMP, and CFDA GMP on following areas throughout the entire manufacturing process, provide compliance assessment, and recommend corrective and preventative actions.
我们的GMP资深顾问会从法规符合性的角度以FDA cGMP、欧盟GMP、及中国新版GMP为依据，针对生产全过程，从下述等多个方面对药企的质量管理体系进行差异分析，评估其法规符合性，并提出符合药企现状的整改建议。
- Personnel and Training人员及培训
- Premises and Equipment厂房及设施
- Equipment Management 设备管理
- Material Management 物料管理
- Process Control 生产过程控制
- Document Control 文件控制
- Laboratory Test实验室检测
- Verification and Validation确认验证
- Quality Review 质量回顾
- Complaints and Recall 投诉及召回