CPR-08-01-a Self-inspection.doc

REFERENCE TO A POLICY 参考方针 CPO-08: Internal Audits. CPO-08：内部审计 PURPOSE 目的 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。 SCOPE 范围 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。 RESPONSIBILITY 职责 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。 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。 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。 DEFINITIONS 定义 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。 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。 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。 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。 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