annual-review-产品质量年度回顾英文版模板

1、xxxxQxxaxxxxxSOPAnnual ReviewsSOP No： M-050Effective:Supersedes: 11/8/01DBC: 6.17Page 1 of 21.0 PURPOSE:To perform the annual review of complai nts, recalls, returned or salvaged drug products, no tificati on of rejecti on forms, out of specificati on result forms, critical system cha nge con trol f

2、orms, in vestigati on /deviati on report forms, product specificati ons, manu facturi ng and con trol procedures.2.0 SCOPE:2.1 All Customer compla in ts, recalls, retur ned or salvaged drug products, no tificati on of rejectio n forms, out of specificati on result forms, critical system cha nge con

3、trol forms, in vestigati on /deviati on reports that occurred throughout the year will be reviewed on an annual basis.2.2 Applies to all products and the docume nts perta ining to their manufacture.3.0 RESPONSIBILITY:3.1 It is the resp on sibility of the Quality Con trol/Stability Systems Tech nicia

4、n to prepare a separate annual report on each product that is marketed by Compa ny.3.2 The Quality Assura nee Assista nt Scien tist an d/or the QA Man ager is resp on sible for review ing the docume ntati on from selected batches of every product.3.3 The QA/QC Director an d/or the QA Ma nager and/or

5、 QC Man ager are resp on sible for:3.3.1 Review ing each products annual report.3.3.2 Perform review of recalls, retur ned or salvaged drug products, no tificati on of rejecti on forms, out of specificati on result forms, critical system cha nge con trol forms, investigation/deviation report forms.3

6、.4 The Regulatory Affairs Paralegal is resp on sible for providi ng a summary annual review report of all compla ints by product.3.5 The Regulatory Affairs Director is resp on sible for review ing the summary annual compla int report.3.6 The QA/QC Director is resp on sible for no tify ing the resp o

7、n sible officials of the compa ny in writing if an investigation is performed on Returned Drug products or on Drug Products that are salvaged because of improper storage con diti ons.Approver/DateApprover/DatePrincipal AuthorApprover/DateXXXXXXXXQuality SOPAnnual ReviewsSOP No： M-050Effective:Supers

8、edes: 11/8/01DBC: 6.17Page 2 of 24.0 PROCEDURE:4.1 The records associated with a selected batch/lot of fini shed productor each bulk formula,in cludi ng all raw material and packagi ng material records that are used to manu facture and package the batch/lot of product are reviewed for content and co

9、mplete ness annu ally.4.2 The records for compla in ts, recalls, retur ned or salvaged drug products, no tificati on of rejectio n forms, out of specificati on result forms, critical system cha nge con trol forms and in vestigati on /deviati on reports are reviewed. The annual review filec ontains t

10、he QC review results summarized by product, QA results summarized for each bulk formulati on, and the Regulatory Affairs results summarized by product.4.2.1 The Regulatory Affairs Paralegal will log all complaints for each product on a list,in dicat ing the type of compla in t, itan darfrenerencyote

11、d This list isreviewed by the Regulatory Affairs Director to determ ine any sig nifica nt cha nges in freque ncy or type of compla int for each product from previous years.4.2.2 The causes for any recalls will be examined and an investigation will be performed to assure all correct ions were made to

12、 the reas on for the recall. The report of the in vestigati on is issued to the resp on sible officials of the compa ny.4.2.3 The retur ned goods policy is reviewed for content and impleme ntati on. The retur ned goods reports are reviewed to assure complete ness and accuracy. Any n ecessary cha nge

13、s will be made as required. If an in vestigati on is required, the resp on sible officials of the compa ny will be no tified.4.2.4 Notificati on of Reject ion Forms are reviewed and summarized for tren ds.4.2.5 Critical System Change Con trol forms are reviewed for complete ness.4.2.6 Out of Specifi

14、cati on Result Forms are reviewed and summarized for tren ds.4.2.7 In vestigati on/Deviati on Reports are reviewed to determ ine any tren ds. Recomme ndati ons for improveme nt in an area will be give n to the correct departme nt man ager.4.3 Each product ' s annual report, which contains the fo

15、llow in geviewed:4.3.1 Stability Assay test results are recorded for each product on a yearly basis. The data is reviewed throughout the shelf life of the product. If a product has no expirati on date the n results are recorded for at least 48 mon ths and reviewed.4.3.2 Quality Con trol test results

16、 for each batch are reviewed for each product. The data are tabulated inan Excel spreadsheets nd a summary is gen erated for each product.4.4 Product specifications, Product Control Procedures, the current Formula and theManu facturi ng Procedures are updated as n eeded based on the annual review.4.

17、5 The annual review is docume nted and filed物 业安保培训方案为规范保安工作，使保安工作系统化/规范化，最终使保安具备满足工作需要的知识和技能，特制定本教学教材大纲。XXXXXXXXQuality SOPAnnual ReviewsSOP No： M-050Effective:Supersedes: 11/8/01DBC: 6.17Page 3 of 2一、课程设置及内容全部课程分为专业理论知识和技能训练两大科目。其中专业理论知识内容包括：保安理论知识、消防业务知识去肚、职业道德、法律常识、保安礼仪、救护知识。作技能训练内容包括：岗位操作指引、勤务技

18、能、消防技能、军事技能。二培训的及要求培训目的1保安人员培训应以保安理论知识、消防知识、法律常识教学为主，在教学过程中，应要求学员全面熟知保安理论知识及消防专业知识，在工作中的操作与运用，并基本掌握现场保护及处理知识2）职业道德课程的教学应根据不同的岗位元而予以不同的内容，使保安在各自不同的工作岗位上都能养成具有本职业特点的良好职业道德和行为规范）法律常识教学是理论课的主要内容之一，要求所 有保安都应熟知国家有关法律、法规，成为懂法、知法、守法的公民，运用法律这一有力武器与违法犯罪分子作斗争。工作入口门卫守护，定点守卫及区域巡逻为主要内容，在日常管理和发生突 发事件时能够运用所学的技能保护公司

19、财产以及自身安全。2、培训要求1保安理论培训通过培训使保安熟知保安工作性质、地位、任务、及工作职责权限，同时全面掌握保安专业知识以及在具体工作中应注意的事项及一般情况处置的原则和方法。2）消防知识及消防器材的使用通过培训使保安熟知掌握消防工作的方针任务和意义，熟知各种防火的措施和消防器材设施的操作及使用方法，做到防患于未燃，保护公司财产和员工生命财产的安全。3）法律常识及职业道德教育通过法律常识及职业道德教育，使保安树立法律意识和良好的职业道德观念，能够运用法律知识正确处理工作中发生的各种问题；增强保安人员爱岗敬业、无私奉献更好的为公司服务的精神。4）工作技能培训其中专业理论知识内容包括：保安

20、理论知识、消防业务知识丑、职业道德、法律常识、保安礼仪、救护知识。作技能训练内容包括：岗位操作指引、勤务技能、消防技能、军事技能。二培训的及要求培训目的安全生产目标责任书为了进一步落实安全生产责任制，做到“责、权、利”相结合，根据我公司2015年度安全生产目标的内容，现与财务部签订如下安全生产目标：一、目标值：1、全年人身死亡事故为零，重伤事故为零，轻伤人数为零。2、现金安全保管，不发生盗窃事故。3、每月足额提取安全生产费用，保障安全生产投入资金的到位。XXXXXXXXQuality SOPAnnual ReviewsSOP No： M-050Effective:Supersedes: 11/8/01DBC