CPR-08-01-a Self-inspection

Number / version:

Document name:General Procedure

Corporate Manual

CPR-08-01-a

自检

翻译:肖雄涛

1. REFERENCE TO A POLICY 参考方针

1.1.

CPO-08: Internal Audits. CPO-08：内部审计

2. PURPOSE 目的

2.1.

To evaluate on a regular basis the effectiveness and suitability of the quality

system and compliance with the Actavis Corporate Manual, GXP and other

relevant regulatory requirements, and to recommend any necessary corrective/

preventive actions.

为了定期地评估质量系统的有效性和适宜性，执行Actavis公司手册、GXP和其它规章制度的彻底程度，为了建议实施任何必要的整改/预防措施。

3. SCOPE 范围

3.1.

This procedure pertains to self-inspections of all quality systems within Actavis.

本规程适用于Actavis集团内的所有质量系统的自检活动。

4. RESPONSIBILITY 职责

4.1.

The Quality Assurance unit (QA) at each site is responsible for organising the

inspections and for the follow up on corrective/preventive actions.

每个公司的QA部门负责组织检查并跟踪整改/预防措施的执行情况。

4.2.

The lead auditor is responsible for carrying out the self-inspection, to produce

an inspection report and to schedule and conduct a closing meeting.

主审计师负责开展自检，完成审计报告，安排和主持总结会议。

4.3.

The manager for the inspected unit is responsible for corrective/preventive

actions taken, following an inspection, and to present the audit findings to the

unit staff.

被检查单位的经理负责在检查之后制定整改/预防措施，并将审计缺陷告知所有员工。

5. DEFINITIONS 定义

5.1.

Auditor: A person who has the appropriate training and experience to be

qualified to carry out an inspection.

审计员：经适当的培训，拥有一定经验，具有实施检查活动资格的人。

5.2.

Corrective Action: Action(s) designed to identify and eliminate root causes of

non-compliances.

整改措施：用来界定和排除发生偏离的根本原因的活动。

5.3.

Main components of GXP: Personnel, premises, equipment, documentation,

production, quality control, distribution, complaints, recalls, self inspections

and validation.

GXP要素：人员、厂房、仪器、文件、生产、质量控制、配送、投诉、召回、自检和验证。

Actavis Group This document is uncontrolled if printed out Page 1 of 4

Number / version:

Document name:CPR-08-01-a

Self-Inspections

5.4.

Preventive Action: Action(s) designed to prevent the occurrence of non-compliances.

预防措施：用来防止发生偏离事件的活动。

5.5.

Self-inspection: Pre-announced internal inspection carried out on a

regular basis to evaluate the effectiveness and suitability of the quality

system and compliance with the Corporate Manual, GXP and other

relevant regulatory requirements, and to recommend any necessary

corrective/preventive actions.

自检：预先通知的内部检查，其目的是为了评估质量系统的有效性和适宜性，执行Actavis公司手册、GXP和其它规章制度的彻底程度，为了建议实施必要的整改/预防措施。

6. PROCEDURES 规程

Scheduling 安排

6.1.

All main components of GXP shall be inspected at least every 3 years, a self-inspection plan must be in place and accepted by the local quality board.

应该至少每3年对GXP的所有要素进行一次检查，必须制定自检计划并经当地质量委员会的批准。

6.2.

IT departments and control of computer systems shall be included in the

internal audit plan if validated computer systems are used.

如果使用经验证的计算机系统，IT部门和计算机控制系统应该须包含在内部审计的计划内。

6.3.

The inspection plan shall be presented to the relevant division/department

managers.

检查计划应该分发相关组织/部门的经理。

6.4.

The frequency of self-inspections for each main component of GXP shall be

decided according to criticality of the activity and gravity of previous non-compliances.

自检计划中GXP的每个主要因素的检查周期的制定应该根据以往其发生偏离事件的频繁程度和危害性来确定。

6.5.

If the inspection reveals grave non-compliances the relevant component shall

be rescheduled and inspected more frequently than stipulated in the original

plan.

如果检查显示某些因素发生了严重偏离的情况，那么这些因素的检查计划应该重新制定，其检查要比一般规定的频率高。

Unscheduled Self-Inspections 随机自检

6.6.

Special occasions may demand additional self-inspections, for example recalls

and repeated rejections. Requests for unscheduled self-inspections shall be

directed to QA who will evaluate the need and organise the inspection.

特殊的场合可能需要增加自检，比如发生召回和再三的拒绝事件。随机的自检需要应该由QA直接评估并且亲自组织这样的自检活动。

Actavis Group This document is uncontrolled if printed out Page 2 of 4

Number / version:

Document name:CPR-08-01-a

Self-Inspections

The Self-Inspection Team 自检小组

6.7.

A self-inspection team shall be appointed by QA and be made up of a mixture

of people, including experts in GXP and persons familiar with the field and area

to be inspected.

自检小组应该由QA直接领导，并由不同的人组成，包括GXP专家和熟悉被检查区域的人员。

6.8.

The lead auditor (team leader) shall be independent of the unit to be inspected

and have the authority and experience to organise and manage a team activity.

审计小组长应独立于被检查的部门，并且经授权有足够的经验协调和管理小组活动。

6.9.

Auditors shall be trained in carrying out inspections and have the necessary

knowledge of the GXP components to be inspected and the relevant sections of

this Manual.

在实施检查的过程中审计员应该得到培训，掌握需检查的GXP因素和相关部门手册的知识。

6.10.

The lead auditor (team leader) will submit the inspection scope to the relevant

manager, and coordinate scheduling of the opening and closing meetings.

审计小组长要将检查的范围呈送相关经理，并且协调安排通风和总结会议。

The Self-Inspection 自检

6.11.

The inspection is carried out according to the self-inspection plan and

according to an SOP for self-inspection.

自检是按照自检计划和相关自检SOP的规定而实施的。

6.12.

A program including the purpose and scope of inspection has to be followed

during the inspection.

在自检过程中要有一份包括了检查目的和范围的纲要来指导检查活动。

6.13.

Before a self-inspection is performed the auditor(s) shall review relevant

sections of this Manual and any relevant GXP or other regulatory requirements.

在自检开始之前审计员应充分学习本手册的相关章节和GXP，以及其它法律、法规要求。

6.14.

Selected findings from previous audit should be checked for completion and

effectiveness.

选择上次审计发现，检查其完成情况和效力。

6.15.

It must be assured that all areas defined in the audit scope are examined.

要保证在审计范围中规定的所有区域都有被检查。

6.16.

The lead auditor shall present the findings to the manager(s) for the inspected

unit(s) on a closing meeting.

在总结会议上审计小组组长应为被检查部门的经理提供审计缺陷。

Reporting 报告

6.17.

The inspection team shall issue as quickly as possible an inspection report

detailing the findings of the inspection, criticality of the findings.

检查小组应尽快起草关于检查发现的细节描叙和发现的危害程度的报告。

Actavis Group This document is uncontrolled if printed out Page 3 of 4

Number / version:

Document name:CPR-08-01-a

Self-Inspections

Corrective Actions/Preventive Actions 整改/预防措施

6.18.

The manager(s) shall decide what corrective/preventive actions are to be taken

regarding each finding. This is documented in the inspection report and a

responsible person assigned for each action and a target date for completion

agreed upon.

管理人员应确定每个缺陷应该采取的整改/预防措施。每项措施的预期完成时间和责任人要记录在文件中。

6.19.

The lead auditor shall evaluate if the suggested corrective/preventive actions

are adequate.

主审计师应评估建议的整改/预防措施是否可行。

6.20.

The corrective/preventive actions should be completed in a timely manner.

纠正/预防措施应该在规定的时间内完成。

6.21.

The inspection report shall be sent to QA for follow up.

检查报告应该呈送QA以便跟踪。

Follow up 跟踪

6.22.

QA monitors the progress of the corrective action and alerts the responsible

persons when corrective/preventive actions are to be completed.

QA监控整改措施的进展情况，提醒责任人何时要完成整改/预防措施。

6.23.

The local quality board shall be informed on regular basis about status of

corrective/preventive actions.

整改/预防措施的情况应该以正规的形式告知当地质量委员会。

6.24.

The inspection report is closed when all corrective/preventive actions are

completed.

当所有纠正/预防措施完成后检查报告就可以封存了。

Archiving 存档

6.25.

QA shall archive the original inspection reports in a safe and a secure place for

a minimum of 6 years.

QA应在一个安全可靠的地方保存原始检查报告至少6年。

Actavis Group This document is uncontrolled if printed out Page 4 of 4