GMP内审
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Version No.:2 SOP
Read this SOP carefully before you sign it.
I. 目的PURPOSE:
建立一个XX GMP内审的体系，保证企业的运行符合cGMP的要求。
To establish an XX GMP internal audit’s system to make sure all operations
in XX 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XX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 XX is 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:
版本号：2
Version No.:2 SOP 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)
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●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
●仓库中物料的隔离 Segregation of materials
●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 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计
的岗位
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Lead Auditor should be independent of the departments audited by
Auditor 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。
Serve as Lead Auditor and conduct the audits according to the approved
plan.
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’s
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.
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。
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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
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.
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.
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.
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审计安排须表明将要被审计的部门/系统，审计负责人，和任何将参与月度审
计工作的队伍成员。
The schedule will indicate the area/system to be audited, the Lead
Auditor and any team members expected month for execution.
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 one week
before the audit.
pending.
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’s, area
procedures, etc.
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
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.
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，或者是
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) 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
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●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
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Deviations from established procedures that DO NOT have 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)
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。TrackWise将作为管理审计
报告的系统。任何潜在缺陷将立即告知责任部门。
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 QA for checking. The
corrective actions, deadline of completing the corrective actions and
responsible person should be included in the report.
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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QA。
The individual department should take responsibility for following up the
corrective action and send a written following report to QA next month.
注：各部门的GMP自查不需要采用Trackwise系统。
Self-audit of each department doesn’t use Trackwise system.
3. 审计负责人负责发出内部审计报告。
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.
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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。
Internal audit reports should be written and submitted within 15 days of
audit completion.
9.3 以上内审报告和整改报告应按照SOPXX的要求保存.
Above Internal GMP Audit Reports and Corrective action Report
should be preserved according to SOP XX requirement.
9.4 Q A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’s confidential documents.
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
附录I 流程图Appendix I Flow Chart
附录2 TrackWise流程图Appendix II TrackWise Flows
审计 Audit
Audit Observation WorkFlow