Audited Company "CSPC OUYI Pharmaceutical Co, Ltd.;
No. 88 Yangzi Road Economic and Technological
Development Zone Shijiazhuang - 052160,
Hebei, China"
Audit scope Indomethacin
Company auditor Sopharma AD, Sofia, Bulgaria
16, Iliensko chausse, 16,
1220 Sofia, Bulgaria
Auditors Iliana Georgieva
Dimitar Dimitrov
Audit time and date 9:00 AM CST -5:00 PM CST; 28.03.2025
Audit type On-site| Audited Company | CSPC OUYI Pharmaceutical Co, Ltd.; <br> No. 88 Yangzi Road Economic and Technological <br> Development Zone Shijiazhuang - 052160, <br> Hebei, China |
| :--- | :--- |
| Audit scope | Indomethacin |
| Company auditor | Sopharma AD, Sofia, Bulgaria |
| | 16, Iliensko chausse, 16, |
| | 1220 Sofia, Bulgaria |
| Auditors | Iliana Georgieva |
| | Dimitar Dimitrov |
| Audit time and date | $9: 00$ AM CST -5:00 PM CST; 28.03.2025 |
| Audit type | On-site |
Audit criteria: EudraLex, EU GMP, Part II; EU GMP Part I; ICH Q7 - Guide for Active ingredients; ISO 9001:2015 QMS requirements; other 审核标准:EudraLex,欧盟 GMP,第 II 部分;欧盟 GMP 第 I 部分;ICH Q7 - 活性成分指南;ISO 9001:2015 质量管理体系要求;其他
Audit methodology - Review and discussion of documents and topics under scope of audit: The company licenses and certificates, SMF, APQR and SOPs. Change control, deviation management, QRM, OOS/OOT, customer complaint management, recall management, vendor approval, selfinspection program, training (GMP and specific), qualification (equipment, supply systems, facility), validation management, quality management review, documentation system (forms, records, protocols), etc. The listed topics will be reviewed through SOPs and generated records and the company approach to ensure the product quality and safety shall be presented. 审计方法 - 审查和讨论审计范围内的文件和主题:公司许可证和证书、SMF、APQR 和 SOP。变更控制、偏差管理、QRM、OOS/OOT、客户投诉管理、召回管理、供应商批准、自检计划、培训(GMP 和特定)、资格认证(设备、供应系统、设施)、验证管理、质量管理审查、文档系统(表格、记录、协议)等。列出的主题将通过 SOP 和生成的记录进行审查,并介绍公司确保产品质量和安全的方法。
Onsite visit (or virtual tour) of production, warehouses, QC laboratories and Utility systems will be conducted. 将对生产、仓库、QC 实验室和公用事业系统进行现场访问(或虚拟参观)。
Morning Session 上午会议
Time 时间
Activity 活动
I. 开幕会议。
讨论审计目标和时间表
I. Opening meeting.
Discussion of the audit objectives and schedule
I. Opening meeting.
Discussion of the audit objectives and schedule| I. Opening meeting. |
| :--- |
| Discussion of the audit objectives and schedule |
Other issues from company side that should be taken in account during the audit 审计过程中应考虑的公司方面的其他问题
II. Onsite visit: (in case of remote / online audit - virtual facility tour) II. 现场访问:(如果是远程/在线审核 - 虚拟设施参观)
1. Warehouse for raw materials 1. 原材料仓库
2. Warehouse for finished products 2. 成品仓库
3. Production 3. 生产
4. Packaging 4. 包装
5. Supply systems: HVAC, PW system, other 5. 供电系统:HVAC、PW 系统、其他
6. QC laboratory and microbiological laboratory 6. QC 实验室和微生物实验室
7. Other 7. 其他
Break 破
Morning Session
Time Activity
"I. Opening meeting.
Discussion of the audit objectives and schedule"
Other issues from company side that should be taken in account during the audit
II. Onsite visit: (in case of remote / online audit - virtual facility tour)
1. Warehouse for raw materials
2. Warehouse for finished products
3. Production
4. Packaging
5. Supply systems: HVAC, PW system, other
6. QC laboratory and microbiological laboratory
7. Other
Break| Morning Session | |
| :---: | :---: |
| Time | Activity |
| | I. Opening meeting. <br> Discussion of the audit objectives and schedule |
| | Other issues from company side that should be taken in account during the audit |
| | II. Onsite visit: (in case of remote / online audit - virtual facility tour) |
| | 1. Warehouse for raw materials |
| | 2. Warehouse for finished products |
| | 3. Production |
| | 4. Packaging |
| | 5. Supply systems: HVAC, PW system, other |
| | 6. QC laboratory and microbiological laboratory |
| | 7. Other |
| | Break |
Audit Agenda 审计议程
Afternoon session 下午会议
Time 时间
Activity 活动
I. Documentation review: 一、文件审核:
APQR for audited product - related SOP, last report and staff training 针对经审核产品的 APQR - 相关 SOP、最后报告和员工培训
Deviation management - related SOP and examples 偏差管理 - 相关 SOP 和示例
Change control management - related SOP and examples, list of all registered change controls from previous year 变更控制管理 - 相关 SOP 和示例,上一年所有已注册变更控制的列表
Complaint management - related SOP and examples 投诉管理 - 相关 SOP 和示例
Quality risk management - related SOP and practical examples and reports 质量风险管理 - 相关的 SOP 和实际示例和报告
CAPA management - related SOP and examples CAPA 管理 - 相关 SOP 和示例
OOS and OOT test results - related SOP and examples for OOS batches OOS 和 OOT 测试结果 - 相关 SOP 和 OOS 批次示例
Recall management - related SOP and review of records, mock recalls 召回管理 - 相关的 SOP 和记录审查、模拟召回
Data integrity - related SOP and examples from the facility tour discussion 数据完整性 - 与设施参观讨论相关的 SOP 和示例
Material management - procedure and records 物料管理 - 程序和记录
Cleaning, disinfection and fumigation practices 清洁、消毒和熏蒸做法
Batch manufacturing record for one batch and respective analytical records; issued documents of batch release activities (related SOP and operating forms) 一个批次的批次制造记录和相应的分析记录;出具的批次放行活动文件(相关 SOP 和操作表格)
Reprocess and rework of products, recovery of materials - SOP, protocols, records 产品的再加工和返工、材料回收 - SOP、协议、记录
Internal audit program - review. Personnel. Trainings - SOPs and records 内部审计计划 - 审查。人员。培训 - SOP 和记录
Calibration program - main production equipment and QC instruments 校准程序 - 主要生产设备和 QC 仪器
Qualification of production and QC equipment and supply systems (AHU, PWS, etc.) 生产和质量控制设备和供应系统(AHU、PWS 等)的认证
Preventive maintenance program for main production and QC equipment 主要生产和 QC 设备的预防性维护计划
Qualification of service providers - related SOP and on-site audit reports 服务提供商的资格 - 相关的 SOP 和现场审计报告
Vendor qualification practices - related SOP and records 供应商资格认证实践 - 相关 SOP 和记录
Computerized systems validation for production and QC labs - SOP and records 生产和 QC 实验室的计算机化系统验证 - SOP 和记录
Stability program for audited products (in case of API and finished product audit) 被审核产品的稳定性计划(在 API 和成品审核的情况下)
Environmental monitoring of clean area (in case of API and finished product audit) 洁净区的环境监测(在 API 和成品审计的情况下)
Validation master plan. Process and cleaning validation activities for audited product (related SOP, protocols and reports) (in case of API and finished product audit) 验证主计划。被审核产品的工艺和清洁验证活动(相关 SOP、协议和报告)(在 API 和成品审计的情况下)
(Other specific topics depending of audit scope) (其他特定主题,具体取决于审核范围)
II. Time for auditor statement preparation II. 审计师声明的准备时间
III. Closing meeting III. 闭幕会议
Afternoon session
Time Activity
I. Documentation review:
APQR for audited product - related SOP, last report and staff training
Deviation management - related SOP and examples
Change control management - related SOP and examples, list of all registered change controls from previous year
Complaint management - related SOP and examples
Quality risk management - related SOP and practical examples and reports
CAPA management - related SOP and examples
OOS and OOT test results - related SOP and examples for OOS batches
Recall management - related SOP and review of records, mock recalls
Data integrity - related SOP and examples from the facility tour discussion
Material management - procedure and records
Cleaning, disinfection and fumigation practices
Batch manufacturing record for one batch and respective analytical records; issued documents of batch release activities (related SOP and operating forms)
Reprocess and rework of products, recovery of materials - SOP, protocols, records
Internal audit program - review. Personnel. Trainings - SOPs and records
Calibration program - main production equipment and QC instruments
Qualification of production and QC equipment and supply systems (AHU, PWS, etc.)
Preventive maintenance program for main production and QC equipment
Qualification of service providers - related SOP and on-site audit reports
Vendor qualification practices - related SOP and records
Computerized systems validation for production and QC labs - SOP and records
Stability program for audited products (in case of API and finished product audit)
Environmental monitoring of clean area (in case of API and finished product audit)
Validation master plan. Process and cleaning validation activities for audited product (related SOP, protocols and reports) (in case of API and finished product audit)
(Other specific topics depending of audit scope)
II. Time for auditor statement preparation
III. Closing meeting| Afternoon session | |
| :---: | :---: |
| Time | Activity |
| | I. Documentation review: |
| | APQR for audited product - related SOP, last report and staff training |
| | Deviation management - related SOP and examples |
| | Change control management - related SOP and examples, list of all registered change controls from previous year |
| | Complaint management - related SOP and examples |
| | Quality risk management - related SOP and practical examples and reports |
| | CAPA management - related SOP and examples |
| | OOS and OOT test results - related SOP and examples for OOS batches |
| | Recall management - related SOP and review of records, mock recalls |
| | Data integrity - related SOP and examples from the facility tour discussion |
| | Material management - procedure and records |
| | Cleaning, disinfection and fumigation practices |
| | Batch manufacturing record for one batch and respective analytical records; issued documents of batch release activities (related SOP and operating forms) |
| | Reprocess and rework of products, recovery of materials - SOP, protocols, records |
| | Internal audit program - review. Personnel. Trainings - SOPs and records |
| | Calibration program - main production equipment and QC instruments |
| | Qualification of production and QC equipment and supply systems (AHU, PWS, etc.) |
| | Preventive maintenance program for main production and QC equipment |
| | Qualification of service providers - related SOP and on-site audit reports |
| | Vendor qualification practices - related SOP and records |
| | Computerized systems validation for production and QC labs - SOP and records |
| | Stability program for audited products (in case of API and finished product audit) |
| | Environmental monitoring of clean area (in case of API and finished product audit) |
| | Validation master plan. Process and cleaning validation activities for audited product (related SOP, protocols and reports) (in case of API and finished product audit) |
| | (Other specific topics depending of audit scope) |
| | II. Time for auditor statement preparation |
| | III. Closing meeting |