. Company profile 公司簡介 2. Description of facility/premises (building, layout etc) 生產車間設施描述 3. Any GMP programs, certificates, licenses GMP 或質量證書 4. Resume and certification of QA person 質监經理學經歷證件 5. List of equipment/instrument for manufacturing 生產設備及儀器清单 6. List of standard operational procedures (SOP) covering: 下列工厂规程文件清单 Premises e.g. warehouses, HVAC 厂房设备管理, 仓储管理, 收发料管理 Personnel, including Training program 岗位操作规程, 职工培训管理 Manufacturing process and control, including maintenance, calibration programs 工艺规程, 工艺管理, 生产管理, 校正, 验证管理 Quality control (QC) and assurance (QA) system/procedures 质量检验管理 Sampling, testing procedures for raw materials, intermediates, packaging materials, finished products 试验检验管理, 包装材料标准, 原辅料标准, 半成品中间体标准, 成品标准 Stability programs 安定性检验 Sanitation & hygiene programs 卫生管理, 职工健康管理 Batch records & documentation system 文件管理, 记录表格管理 Self-inspection program 自我檢查計畫 Management of contractors 供應商, 物资采购管理 Recall of products 回收退货产品管理