筑牢质量防线 共铸卓越品质——麦科奥特完成药品CDMO合作机构年度质量审计

系统性审计：多维透视质量体系成熟度

审计团队严格依据现行GMP规范及132号文件要求，从“人员、设备、物料、规程、环境、检测”6个方面对受托方质量体系进行全方位核查，重点覆盖：

1. 质量体系架构：组织机构、关键人员资质、部门职责  

2. 设备设施管控：洁净区环境监测、制药用水系统管理、设备仪器确认与验证  

3. 数据可靠性：电子数据审计追踪、计算机化系统权限管理、原始数据链完整性  

4. 质量事件处置：偏差根本原因调查、CAPA有效性验证、变更处置合规科学  

建设性闭环：推动质量持续提升 

在末次会议上，双方就审计发现的改进机会达成一致共识。受托方对于我方审计团队发现的问题和建议给予了充分认可，承诺将制定详尽的整改计划，不断提升并完善药品生产的质量体系，保证出厂药品质量。

Micot Strengthens CDMO Partnership Through Annual Quality Audit

Systematic Audit: A Multidimensional Lens on Quality System Maturity

The audit team conducted a comprehensive review of the contracted manufacturer's quality system in strict accordance with current GMP regulations and the requirements of Document No. 132. The audit encompassed six key aspects—Personnel, Equipment, Materials, Procedures, Environment, and Testing—with a focus on the following areas:

1. Quality System Framework: organizational structure, qualifications of key personnel, and departmental responsibilities.

2. Equipment and Facility Controls: clean area environmental monitoring, pharmaceutical water system management, equipment/ instrument qualification and validation.

3. Data Integrity: audit trails for electronic data, computerized system access management, and integrity of the raw data chain.

4. Quality Event Management: investigation into root causes of deviations, verification of CAPA effectiveness, and compliance-driven scientific change control.

The Constructive Loop: Driving Continuous Quality Improvement 

 At the closing meeting, both parties reached a consensus on the improvement opportunities identified during the audit. The contracted manufacturer fully acknowledged the issues and recommendations raised by our audit team and committed to developing a detailed corrective action plan, with the aim of continuously enhancing and refining the quality system for drug production to ensure the quality of released products.