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 lf-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。脐带怎么消毒>6个月宝宝吐奶
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 lf-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 prent 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 caus 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, premis, equipment, documentation, production, quality control, distribution, complaints, recalls, lf 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。
5.4.Preventive Action: 梦到脱发Action(s) designed to prevent the occurrence of non-compliances.
讽刺人的成语预防措施：用来防止发生偏离事件的活动。
5.5.生活像什么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 lf-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 ud.
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 prented 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 lf-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 lf-inspections, for example recalls and repeated rejections. Requests for unscheduled lf-inspections shall be directed to QA who will evaluate the need and organi 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。
The Self-Inspection Team 自检小组
6.7.市场营销论文A lf-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。鳄梨
6.8.The lead auditor (team leader) shall be independent of the unit to be inspected and have the authority and experience to organi 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 ctions 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.美丽的玫瑰花The inspection is carried out according to the lf-inspection plan and according to an SOP for lf-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 purpo and scope of inspection has to be followed during the inspection.
