GMP 内审体系指引
I.
目的 PURPOSE:
建立一个 DXC GMP内审的体系，保证企业的运行符合
cGMP的要求。
To establish an DXC GMP internal audit ’s system to make sure all operations in DXC T.O are in compliance with the cGMP.
用 TrackWise 作为管理审计报告的系统， 并跟踪所有相关行动 , 确保 DXC符合公司总部的指示和政策、 cGMP和产品分布地的政府法律机构所建立的要求。
Assure DXCis operating
in compliance with corporate guidelines and policies, current
GMP’ s and any other requirements established by the Regulatory Agencies where the products are distributed using TrackWise as the system to manage the audit report and follow up on all corrective actions.
II. 范围 SCOPE:
1. 需被审计的部门有：
The departments need to be audited are: 制造部 ，工程部 ， QC，QA，仓储部
，物控部 ，技术服务部
Lactam Workshop, Non-Lactam Workshop, Engineering Department, QC, QA, Warehouse, Material Management Department and Technical Service Department
2. QA GMP月度审计包括下列内容，但不限于此：
Monthly QA GMP internal audits must include, but not be restricted to:
工厂设施 Premises
维护 Maintenance 校验 Calibration 流向 Flow
标识系统 Labeling system
净化空调系统 HVAC system
工艺用水系统 WFI & USP water system
设备 Equipment
维护 Maintenance
清洁 Cleaning
标识系统 Labeling system
状态控制 Status control
区域 Area
设备 Equipment
物料 Material
文件实施和版本控制
Ducumentation Practice & revision control
标准操作程序 SOP
原始记录 MLS/PLS
测试标准、方法、记录
TS/TM/Report
批生产记录 Batch record
生产 Production
清场、清洁、环境控制
Housekeeping/cleaning/clearance/environmental control system 变动控制系统 CCF system 过程控制 Process management
中心称量室配料程序
Dispensing practices
质量保证 / 控制 QA/QC
异常情况 /OOS控制 Incident deviation control/OOS
验证（工艺、设备、水系统、空调系统、设备清洁）
Validation (Process, equipment, Water system, HVAC system & Equipment cleaning)
标准品、标准溶液、试剂和样品的管理
Reference standards, standard solution, reagents and samples management 稳定性考察和留样规则
Stability testing program, retain sample and storage 分析原始记录 Analytical worksheet 取样 Sampling procedure
GMP培训和记录 GMP training and record 产品的储存、分发
Storage/Distribution of products Segregation of materials
仓库中物料的隔离
标签贮存区域 Label storage area
温湿度控制 Temperature and humidity control
虫鼠控制 Pest/Mouse control
物料系统 Materials system
包装和标签系统 Packaging and Labelling system
抱怨 Complaint
回收 Recall
退货和抢救产品
Returned/Salvaged products
自查系统 Self Inspection
不合格物料的控制
Rejection controls
III. 职责 RESPONSIBILITIES
1. TrackWise 系统管理员 TrackWise System Administrator
为公司用户提供一线系统支持
Provide first line system support to site-end-users. 2. 审计负责人 Lead Auditor
2.1
计的岗位
Lead Auditor should be independent of the departments audited by Auditor
审计负责人应该是不受被审计部门约束的，至少其工作职能是独立于被审
or the Auditor ’ s job function should be independent of the position audited by the Auditor at least.
2.2 准备内审计划，该内审计划应该得到 QA经理的批准。
Prepare the Internal Audit Plan and it should be approved by QA Manager. 2.3 作为审计负责人，按照计划进行审计。
and conduct the audits according to the approved plan.
Serve as Lead Auditor
2.4 用 TrackWise 系统整理审计所发现的缺陷，并为每个被审计部门准备审计报告。
Document observations and prepare a report for each audited Department using TrackWise as system.
2.5 用 TrackWise 来管理审计报告，包括相应的整改防范行动项目。
Using TrackWise as the system manages the audit report including the
completion of corrective actions and the corresponding CAPA
3. QA 经理 QA Manager
3.1 确保审计员受到完全、适当的培训。
Ensure auditors are properly trained. 3.2 批准内审计划书，并保证内审按照日程进行。
Approve the internal audit plan and assure internal audits are conducted as per schedule.
’s
3.3 批准内审报告，并保证其机密性和正确归档。
Approve the internal audit report and assure it is kept confidential and appropriately filed.
4. 被审计部门经理 Audited Department Managers
4.1 确保责任区域与 cGMP要求相符。
Ensure areas of responsibility are in compliance with cGMP’s at all
times.
4.2 审计中，陪同审计员或者指定的人员，无论在原审计过程中还是跟踪审计中，对所
提出的问题提供相应记录和回答。
During the audit, accompany (or assign a designee) the
auditors providing
records and answers as requested during the original, as well as follow up audits.
4.3 保证内审中发现的任何问题都被整改。
Ensure any observation found during an internal audit is corrected. 4.4 敦促审计的反馈及时发出。
Enforce audit response to be issued in a timely manner.
5. 被审计部门总监 Department Directors
5.1 确保经理对内审报告中的不足之处作出整改。
Responsible to ensure Department Managers correct deficiencies stated on internal audit reports.
5.2 敦促审计的反馈及时发出。
Enforce audit response to be issued in a timely manner.
IV.
步骤 PROCEDURE 1. 内部审计安排
Internal Audit Schedule
1.1 每年年初，审计负责人须准备年内的被审计部门日程安排。每年本文
II.1 中所涉
及的部门须被审计到。
At the beginning of each year, a schedule of departments to be audited
during the current year will be prepared by the Lead Auditor. It is the
intent that the departments referred to Part II.1 should be specified and be audited every year.
1.2 内审计划由指定的 QA审计负责人完成。
Internal Audit Plan will be completed by the QA auditor assigned as Lead Auditor.
1.3 审计将根据新药申请 / 注册，质量事件，新设施，抱怨等规范，按照已批准的年度
审计计划进行。
Audits will be conducted yearly as per the approved established schedule
according to NDA/registrations, quality events, new facilities,
complaints, etc. 1.3.1
审计安排须表明将要被审计的部门 审计工作的队伍成员。
/ 系统，审计负责人，和任何将参与月
度
The schedule will indicate the area/system to be audited, the Lead
Auditor and any team members expected month for execution.
1.3.2
在审计开始的一周前，审计负责人将发出审计计划书。 An audit plan will be sent by lead auditor approximately the audit. pending.
one week before
1.3.3
基于 cGMP和部门规程，准备一份审计项目的清单。
Prepare a checklist of the items to be audited based on cGMP procedures, etc.
’ s, area
1.3.4 审计前，检查上一次审计的结果状态，以找出任何未完成的整改。 Before the audit,
verify
status of previous audits to address any open
action
1.3.5
执行审计，并将任何潜在的缺陷告知责任部门的管理人员。
Execute audit and inform Departments responsible management for any potential observations.
1.3.6 缺陷被分类为：
Observations will be classified as:
a. 关键缺陷 –一种直接影响到产品的认定、效力、质量、纯度的，
会导致法规机构执行措施的情况或者问题。 Critical
–a condition
or issue that could directly
affect (or did affect)
或者是
the identity,
strength, quality, and purity of the product or could lead
to action by regulatory authority.
与所建立的程序有偏移，如果不整改，会影响产品质量 Deviations from established procedures which if not corrected will adversely affect product quality
明显不符合 GMP
Obvious GMP violations 缺乏要求的程序
Lack of required procedures 没有反映出质量下降的趋势
Failure to react to negative quality trends 违反政府法规，违法 TGA, EU 或 FDA准则
Observations leading to Regulatory Action i.e. violation of non compliance to the TGA, EU or FDA codes.
b. 主要缺陷 –非直接影响产品质量，或者不会被相关机构在执行法规性检
查中记录下来的情况和问题。同一系统中的多个大缺陷或者不同系统中 的同一个大缺陷可能导致法律机构的行动。
Major –a condition or issue that could indirectly have an impact on
the quality of the product or be cited on a list of observations during a regulatory inspection. A pattern of major observations in the same
system or a pattern in multiple systems could lead to action by regulatory authority.
与所建立的程序有偏移，但对产品有潜在的不利影响
Deviations from established procedures which if not corrected, has the potential to adversely affect product quality
校验超期
Calibration out of date 缺乏预防性维修
Lack of preventative maintenance 对标准程序的要求缺乏操作意识
Lack of operator awareness of standard procedure requirements 生产线上的隔离较差 Poor line segregation 缺乏环境控制
Lack of environmental controls
c. 次要缺陷－与 cGMP要求不符，但对产品没有明显的潜在、直接或间接
的影响。
Minor – failure to follow cGMP
’ s where no potential , direct or
indirect impact to product is evident.
与所建立的程序有偏移，但对产品无潜在的不利影响 Deviations from established
procedures that DONOThave the potential
to adversely affect product 清洁、整洁度较差
Poor housekeeping/cleanliness/tidiness 标准程序有较小的修改
Standard Procedures require minor modification 不完整的文件
Incomplete documentation
e. 违反何种规则（ GMP, SOP etc. ）需在报告中指明
Violations (a reference to the
GMP code or Standard Procedure that is
in violation by the observation)
1.3.7
审计负责人将准备 / 发出审计缺陷报告，并由
QA经理批准。报告应当在
审计结束后的 15 天内发至责任部门经理。 系统。任何潜在缺陷将立即告知责任部门。
TrackWise 将作为管理审计报告的
The audit observations report will be written/issued by the Lead Auditor and approved by the QA Manager. It should be submitted to the responsible department Manager within 15 days of audit completion
(including the exit meeting). Using TrackWise as the system to Manage audit report. Any potential observation will be immediately informed to the responsible department.
注： TrackWise 会给每个审计报告分配一个唯一的控制编号。
Note: TrackWise will assign a unique control number to each audit
record.
2. 各部门的 GMP自查
2.1 QC、QA、仓库、头孢、非头孢、工程部至少应每月进行一次自查。自查报告须经
部门经理签名后并抄送给 QA审核。该自查报告中应包括 : 整改措施，整改时间，责任人。
QC, QA, DW, LP, NP, ENG department must be self-audited at least once a month. The Self-inspection Report should be signed by the related
department managers and copy the reports to QAfor checking. The corrective actions, deadline of completing the corrective actions and responsible person should be included in the report.
3.2 在次月，各部门对整改措施的完成情况进行检查跟踪，并书面报告
The individual department should take responsibility for following up the corrective action and send a written following report to QA next month.
QA。
注：各部门的 GMP自查不需要采用 Trackwise 系统。
Self-audit of each department doesn
3. 审计负责人负责发出内部审计报告。 ’ t use Trackwise system.
The Lead Auditor will be responsible for issuing the internal audit report. 3.1
用 TrackWise 系统来管理审计缺陷， 内审中所发现的缺陷将被记录在案。
The observations
found during the internal
audit will be documented, using
TrackWise as the system to manage audit observations.
3.2 内审报告中的”缺陷”复印件将提供给
QC/QA总监和
QA经理，被审计部门的
总监和经理并提供 QA用
于
TrackWise 归档。
Copies of “observations ” of the Internal Audit report will be provided to the QC/QA Director, QA Manager, the audited Department Director and Manager and for the QA file using TrackWise as system.
4. 须执行措施将转交给部门经理或者指定人员以进行整改行动。当收到这部分内容后，
还必须在 30 天通过 TrackWise 交还给审计负责人。
Actions to be taken will be given to the Department Manager or designee for corrective actions. This part must be returned to the Lead Auditor within 30 days upon receipt using TrackWise.
5. 当所有审计中所发现的缺陷对应的整改防范措施都发出后，
审计可被视为结束。 所
有针对“缺陷”行动的完成 / 执行将通过 TrackWise 作为“审计缺陷”流程来管理。
Upon issuance of all audit observations, the audit will be considered closed.
Completion/implementation of all observations will be managed through the
TrackWise system as audit observations.
6. 被审计部门经理或指定人员应当通知审计负责人其“审计缺陷”已关闭，并提供整改行
动已完成或执行的依据给审计负责人。 审计负责人用 TrackWise 作为管理审计报告的系统，将这些整改依据归入到内审报告中，并更新内审报告。
The audited department Manager or the designee should notify when the audit
observations are closed and provide evidence of completion/implementation to
the Lead auditor.
Lead auditor will attach evidence to the internal audit report
and will update audit report,
using TrackWise as the system to manage the audit
reports.
8. 某些质量事件可能需要立刻审计，在此情况下将不会有通知。
Some quality events may require an immediate audit, in which case there will be no prior notification.
9. 报告 Report
9.1 所有的内审计划书将会被分配一个号码，此号码由审计进行的年份，和
年内
的数字顺序编号组成。 All internal audit plans will be assigned a number which will consist of the year the audit is performed and the numerical sequence of the audit within that year .
9.2 内审报告应在审计完成的 15 天内交出。 within 15 days of
Internal audit reports should be written and submitted
audit completion. 9.3
以上内审报告和整改报告应按照
SOPDXC的要求保存 .
Above Internal GMP Audit Reports and Corrective action Report should be preserved according to SOP DXC requirement.
9.4 QA 每年应该对内审中发现的问题进行趋势分析，并与相关部门讨论此趋势。
QA should analyses the trend of observations
found during
internal
audit
once a year and discuss the trend with related department. 9.5 GMP 内审报告和整改报告应该作为公司的保密文件进行管理。
Internal GMP Audit Reports and Corrective action Report should be
controlled as company
V.
附件 ATTACHED FILES/ APPENDIX 附录 1 工作流程。 Appendix I Flow Chart 附录 2 TrackWise 流程图 Appendix II TrackWise Flows
VI.
修正记录 HISTORY
’s confidential documents.
附录 I
流程图
Appendix I Flow Chart
每年年初审计负责人准备内审日程安
排 。 Lead Auditor prepares Internal Audits ’s schedule at the beginning of each year
审计负责人填写表格 QA-382-05-09 (内审计划 ) Lead Auditor fills out Form QA-382-05-09 (Internal Audit Plan)
QA 经理或者指定人员批准内审计划 QA Manager or designee approves the Internal Audit Plan
在审计开始之前，审计负责人向被审计部 门的经理提供内审计划。 Lead Auditor provides the internal Audit Plan to the Manager of the department to be audited (prior to the audit)
根据 GMP 和公司内部要求， 审计负责人 提供一份须检查项目 / 部门的清单。 Lead Auditor provides a checklist of the Department to be audited based on GMP ’s, department procedures, etc
审计负责人检查上次审计的结果状 态。 Lead Auditor verifies status of previous audit.
审计负责人根据日程执行内部审计
Lead Auditor executes Internal Audit as scheduled.
缺陷被分为关键缺陷， 主要缺陷，次要缺陷
Observations are classified as Critical, Major and Minor
在总结审计时，审计负责人和部门主管、经理召开 结束会议，会议中须指出 TrackWise 所指定的反馈截止日期。 Upon conclusion of audit, a close out meeting is held by Lead Auditor with Department Supervisors and Managers and due dates for responses are established using TrackWise System
审计负责人发出审计报告
Lead Auditor issues Audit Report
QA 经理批准审计报告
QA Manager approves the audit report
审计负责人将给 QC/QA 总监、QA 经理、被审计部门的总 监和经理 发出报告 的副 本。 Lead Auditor will issue copy of the report to QC/QA
Director, QA Manager, Director and Manager of audited department.
审计负责人在审计结束后的 15 天内，用 TrackWise 把审 计报告交给被审计部门经理。 Lead Auditor submits the Audit Report to the responsible department Manager within 15 days of the audit completion using TrackWise System
相关责任人员完成审计报告指出的需执行行动，并
明确整改行动和执行的截止日期， 用 TrackWise，在 收到审计报告后的 30 天内交还给审计负责人。 Responsible person completes actions to be taken of the Audit Report indicating the corrective actions and implementation due dates and submits it to the Lead Auditor within 30 days upon receiving the report using TrackWise System
被指定人员应向审计负责人提供 审计中所发现的缺陷已完成整改 的 依 据 。 Designee provides evidence of audit observations completion to the Lead Auditor
审计负责人用 TrackWise ，在审计报告中附上整改完成的依据，并更新报告。 Lead Auditor attaches evidence of commitments completion to the Audit Report and updates it using TrackWise System
附录 2 TrackWise 流程图
Appendix II TrackWise Flows
审计 Audit
审计员 Site Auditor
开建 Opened
完成 Complete
取消
Cancel
修改 Revise
等待审计缺陷 Awaiting Observations
发起审计缺陷 Observations
审 计 完 成 Observations
Complete
< 关 闭 - 完 成 Closed-Done 关 闭 - 取 消 Closed-Canceled Audit Observation WorkFlow 开建 Opened 审计员 Site Auditor 取消 在所涉及的区域内流 转 Route to Affected Area Cancel 被指派人 Assignee 等待所涉及区域的反馈 AwaitingAff.Area Response 修改 Revise 发 起 者 Originator 系统生成 TWC CAPA 递 交 评 估 Submit for Evaluation QA 代表 Rep CAPA QA 代表 Rep 审计员 Site Auditor 向指派人提出修改 Revise -Assignee 等待审计员进行评估 AwaitingSiteAuditor Observation Evaluation 关 闭 - 取 消 Closed-Canceled 审计员最终批准 Site Auditor Final Approval 关 闭 - 完 成 Closed-Done 因篇幅问题不能全部显示，请点此查看更多更全内容