annual-review-產(chǎn)品質(zhì)量年度回顧英文版模板

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 業(yè)安保培訓方案為規(guī)范保安工作，使保安工作系統(tǒng)化/規(guī)范化，最終使保安具備滿足工作需要的知識和技能，特制定本教學教材大綱。XXXXXXXXQuality SOPAnnual ReviewsSOP No： M-050Effective:Supersedes: 11/8/01DBC: 6.17Page 3 of 2一、課程設置及內(nèi)容全部課程分為專業(yè)理論知識和技能訓練兩大科目。其中專業(yè)理論知識內(nèi)容包括：保安理論知識、消防業(yè)務知識去肚、職業(yè)道德、法律常識、保安禮儀、救護知識。作技能訓練內(nèi)容包括：崗位操作指引、勤務技

18、能、消防技能、軍事技能。二培訓的及要求培訓目的1保安人員培訓應以保安理論知識、消防知識、法律常識教學為主，在教學過程中，應要求學員全面熟知保安理論知識及消防專業(yè)知識，在工作中的操作與運用，并基本掌握現(xiàn)場保護及處理知識2）職業(yè)道德課程的教學應根據(jù)不同的崗位元而予以不同的內(nèi)容，使保安在各自不同的工作崗位上都能養(yǎng)成具有本職業(yè)特點的良好職業(yè)道德和行為規(guī)范）法律常識教學是理論課的主要內(nèi)容之一，要求所 有保安都應熟知國家有關(guān)法律、法規(guī)，成為懂法、知法、守法的公民，運用法律這一有力武器與違法犯罪分子作斗爭。工作入口門衛(wèi)守護，定點守衛(wèi)及區(qū)域巡邏為主要內(nèi)容，在日常管理和發(fā)生突 發(fā)事件時能夠運用所學的技能保護公司

19、財產(chǎn)以及自身安全。2、培訓要求1保安理論培訓通過培訓使保安熟知保安工作性質(zhì)、地位、任務、及工作職責權(quán)限，同時全面掌握保安專業(yè)知識以及在具體工作中應注意的事項及一般情況處置的原則和方法。2）消防知識及消防器材的使用通過培訓使保安熟知掌握消防工作的方針任務和意義，熟知各種防火的措施和消防器材設施的操作及使用方法，做到防患于未燃，保護公司財產(chǎn)和員工生命財產(chǎn)的安全。3）法律常識及職業(yè)道德教育通過法律常識及職業(yè)道德教育，使保安樹立法律意識和良好的職業(yè)道德觀念，能夠運用法律知識正確處理工作中發(fā)生的各種問題；增強保安人員愛崗敬業(yè)、無私奉獻更好的為公司服務的精神。4）工作技能培訓其中專業(yè)理論知識內(nèi)容包括：保安

20、理論知識、消防業(yè)務知識丑、職業(yè)道德、法律常識、保安禮儀、救護知識。作技能訓練內(nèi)容包括：崗位操作指引、勤務技能、消防技能、軍事技能。二培訓的及要求培訓目的安全生產(chǎn)目標責任書為了進一步落實安全生產(chǎn)責任制，做到“責、權(quán)、利”相結(jié)合，根據(jù)我公司2015年度安全生產(chǎn)目標的內(nèi)容，現(xiàn)與財務部簽訂如下安全生產(chǎn)目標：一、目標值：1、全年人身死亡事故為零，重傷事故為零，輕傷人數(shù)為零。2、現(xiàn)金安全保管，不發(fā)生盜竊事故。3、每月足額提取安全生產(chǎn)費用，保障安全生產(chǎn)投入資金的到位。XXXXXXXXQuality SOPAnnual ReviewsSOP No： M-050Effective:Supersedes: 11/8/01DBC