STANDARD OPERATING PROCEDURE标准操作规程REVISION No.: 修订号：Delegation of Approval Authority for GMP-Related ActivitiesGMP相关活动批准权的委派Effective Date 生效日期:Author/Dept. Date起草人/部门: 日期: _Reviewer/Dept. Date审核人/部门: 日期: _Reviewer/Dept. Date审核人/部门: 日期: _Reviewer/Dept. Date审核人/部门: 日期: _Approver/Dept. Date批准人/部门: 日期: _Title: Delegation of Approval Authority for GMP-Related Activities文件名: GMP相关活动批准权的委派Document No. 文件编号:Revision No. 修订号:Effective Date 生效日期:Page 页码: 2 of 51. PURPOSE 目的1.1. This procedure describes the requirements for delegating approval authority for GMP-related activities.本规程描述了委派GMP相关活动批准权的要求。2. SCOPE 范围2.1. This procedure applies to the temporary delegation of Approval Authority for GMP-related activities in .本规程适用于 进行GMP 相关活动批准权的临时委派。2.2. This procedure is a bilingual document written in both English and Chinese.本规程为中英文对照版本。3. REFERENCES 参考资料3.1. N/A4. RESPONSIBILITIES 职责4.1. All delegating personnel should follow this procedure.所有委派人应该遵循本规程的要求。5. DEFINITIONS 定义5.1. Delegation - A temporary designated level of approval authority granted to a subordinate employee. 委派 - 临时委派批准权给下属。6. PROCEDURE 规程6.1. Delegation is permitted in the following situations:下列情况下可以委派：6.1.1. The person whose approval is required is temporarily unavailable (e.g. Vacation, Business Travel or Illness). 批准人暂时不在（例如：度假、公务出差或生病）。6.1.2. The delegating person can delegate to the person whose position is subordinate to the delegation person. Company organization chart will be regarded as position level signature tree.委派人可以将批准权授给自己下属。可以参考公司组织结构图作为职位级别签名图。6.2. Delegation is not permitted in the following situations:下列情况下不可以委派：6.2.1. Quality Assurance responsibilities shall not be delegated to persons outside of the Quality Assurance Department, for example to Production Personnel.质量保证的职责不可以委派给非质量保证部门人员，比如生产人员。Title: Delegation of Approval Authority for GMP-Related Activities文件名: GMP相关活动批准权的委派Document No. 文件编号:Revision No. 修订号:Effective Date 生效日期:Page 页码: 3 of 56.2.2. Production and other departmental personnel shall not delegate responsibilities to Quality Assurance.生产和其他部门人员不可以将职责委派给质量保证部门。6.2.3. The person to whom the responsibility has been delegated may not delegate this responsibility further.接受委派职责的人员不可以再委派该职责。6.3. The person delegating approval authority will complete Form 20-SOP-155-A, “Delegation of Approval Authority” before the delegation becomes effective and will including the following information:批准授权的委派人员填完表格20-SOP-155-A，“批准权委派 ”后委派才能有效，表格包括下列信息：6.3.1. The name and position of the individual who is to assume approval authority;受委派人员的姓名和职位；6.3.2. Specific GMP related activities or document that are being granted for approval to the delegate (for example, approval of documents);受委派人员可以批准的具体GMP相关工作或文件（例如：文件的批准）；6.3.3. Delegation period and reason for the delegation;委派时段和委派原因；6.3.4. The delegated individuals qualifications, including training, job skills and experience;受委派人员资质，包括培训、工作技能和经验；6.3.5. The delegators official signature and date. 委派人员的正式签名和日期。 6.4. The person to whom delegation is being assigned must date and countersign the Form 20-SOP-155-A, “Delegation of Approval Authority” 被委派人必须在表格20-SOP-155-A，“批准权委派”上会签并注明日期。6.5. Only approval authority may be delegated, ultimate responsibility and accountability for the approval remains with the person making the delegation.只能委派批准授权，委派人员保留最终职责和批准解释权。6.6. The delegated individual will sign “Who for Who”.受委派人员将签署“谁为谁”。6.7. The original completed Form 20-SOP-155-A, “Delegation of Approval Authority” will be forwarded to QA for filing.完成的原件表格20-SOP-155-A，“批准权委派”提交给QA进行归档。Title: Delegation of Approval Authority for GMP-Related Activities文件名: GMP相关活动批准权的委派Document No. 文件编号:Revision No. 修订号:Effective Date 生效日期:Page 页码: 4 of 57. ATTACHMENTS 附件7.1. Attachment 1 - “Delegation of Approval Authority” Form 附件1 “批准权委派”表Delegation of Approval Authority批准权委派Delegation of approval authority is granted to:批准权委派给：Name of Individual Position姓名_ 职位_For the following GMP related activities or documents:从事于以下GMP工作和文件：_ Delegation period and reason for the delegation:委派时段和委派原因：_Qualifications of the individual to whom delegation is made:受委派人的资质：Training, Job Skills or Experience培训、工作技能或经验 _Approval authority of the listed functions is granted to the individual named above.上面所列项目的批准权已委派给受委派人。Individual making delegation Position Date委派人_ 职位_日期_Individual Receiving the Delegation Position Date被委派人_ 职位_ 日期_