某外企質(zhì)量管理體系文件

1、總頁數(shù)：15頁(13頁+2個(gè)附件：2頁)Total pages: 15 pages (13 pages + 2 appendices : 2 pages)目錄 TABLE OF CONTENTS: TOC o 1-5 h z HYPERLINK l bookmark10 o Current Document .目的OBJECTIVE2 HYPERLINK l bookmark12 o Current Document .范圍SCOPE2 HYPERLINK l bookmark14 o Current Document .職責(zé)RESPONSIBILITIES2 HYPERLINK l book

2、mark0 o Current Document .步驟PROCEDURE3 HYPERLINK l bookmark2 o Current Document 流程圖 Flowchart3 HYPERLINK l bookmark16 o Current Document 質(zhì)量管理體系 Quality Management System4 HYPERLINK l bookmark18 o Current Document 優(yōu)良藥品生產(chǎn)管理規(guī)范Good Manufacturing Practice5 HYPERLINK l bookmark22 o Current Document 管理原那么

3、Management Principle6.術(shù)語GLOSSARY錯誤!未定義書簽。.參考文件REFERENCES錯誤味定義書簽。.附件APPENDIX錯誤味定義書簽。.其他相關(guān)信息RELATED FORMS AND TRAINING MATERIAL錯誤!未定義書簽。表格Forms錯誤保定義書簽。培訓(xùn)資料Training Material錯誤味定義書簽。Doc. No.: QA004 編號：Version No.: 7.0 版本號Page 10 of 13 頁數(shù)Effective Date:生效日期周期性生產(chǎn)回顧Periodic Production Review每年一次，通常在第一季度完成，

4、以下內(nèi)容應(yīng)被回顧：Once per year, normally done in the 1S, quarter of the year, the content listed below must be reviewed.列出所有需要回顧的產(chǎn)品批次Listing of all batches included in the review生產(chǎn)記錄趨勢(包括產(chǎn)量和中間控制)Production records trends (including yield or output, and in-process control)實(shí)驗(yàn)室記錄趨勢，超標(biāo)分析 Laboratory release test

5、ing record trends, 00S穩(wěn)定性記錄趨勢 Stability testing records trends,產(chǎn)品和物料質(zhì)量標(biāo)準(zhǔn)和測試方法 Product and material specifications and test methods留樣檢查 Retention Sample Check報(bào)廢，返工，再包裝和再加工Rejected, reworked, repack and reprocess batches of product and material偏差 Deviation相關(guān)法規(guī)文件，藥典，其他市場要求，內(nèi)部標(biāo)準(zhǔn)文件，技術(shù)協(xié)議和TTS的最新符合性 Conform

6、ance to up to date and relevant registration, pharmacopoeia, and other market requirement, internal standard documents, Technical agreements and TTS新的注冊申請，再回顧期間申報(bào)的，批準(zhǔn)的或拒絕的申報(bào)資料包括入市后的承諾New Regulatory applications and any variations to registered details submitted, granted or refused during the review

7、period and including any post marketing commitments變更控制 Change Control驗(yàn)證狀態(tài) Validation Status投訴趨勢，召回和退貨 Complaint trends, Recalls and Returned goods.關(guān)鍵設(shè)備和公用設(shè)施的性能Critical Equipment and utilities performance, Exceeded action limits.供應(yīng)商表現(xiàn) Supplier Performance以上所有的內(nèi)容通過以下形式被回顧All above items will be revie

8、wed by:質(zhì)量管理會議 Quality Council Meeting內(nèi)部審計(jì) Internal Audit驗(yàn)證回顧報(bào)告 Validation Review Report周期性牛.產(chǎn)Pl顧(格式參見GQG5008)Periodic Production Review (refer to GQG 5008 for PPR template )QMS執(zhí)行的有效性必須通過自檢和監(jiān)控審計(jì)(L2及L3審計(jì))進(jìn)行評估。The on-going effectiveness of QMS implementation must be assessed through self inspection and

9、 monitoring audits (L2 and L3 audit) where performed.工廠質(zhì)量管理會議的目的 The purpose of Site Quality Council Meeting按照Annex 1的章程逐項(xiàng)進(jìn)行回顧，跟蹤上次會議的行動，通報(bào)當(dāng)月值得關(guān)注的質(zhì)量相關(guān)事 件，確定需采取的行動計(jì)劃及其責(zé)任人、完成時(shí)間。對于Part7, 8-Validation, Calibration, 應(yīng)通報(bào)相關(guān)偏差，并確保預(yù)防糾正措施恰當(dāng)有效。The council is conducted following the charter in Annexl, including

10、 the follow up of Last council, communicate the outstanding issues subjected to quality management, and thenDoc. No.: QA004 編號：Version No.: 7.0 版本號Page 11 of 13 頁數(shù)Effective Date:生效日期confirm the action plan with its owner & due date. For Part7, 8 - Validation &Calibration, the relative deviation must

11、 be discussed to ensure the CAPA effectiveness.QMS執(zhí)行的有效性必須通過自檢和監(jiān)控審計(jì)(L2內(nèi)審及L3 Corporate審計(jì))進(jìn)行評估。 The on-going effectiveness of QMS implementation must be assessed through self Inspection and monitoring audits (L2 Internal audit and L3 Corporate audit) where performed.4.3.1.6 提高 Improving提高是為了預(yù)防質(zhì)量事故的發(fā)生，

12、最終到達(dá)卓越Improving is to prevent the quality problem and issue, ultimately deliver industrial Excellence.在上海工廠，持續(xù)改進(jìn)的建議通常來源于In GSKBS, the recommendations for the continuous improvement is usually derived from:風(fēng)險(xiǎn)管理流程 Risk management process變更管理系統(tǒng) Change Management system質(zhì)量管理會議Quality Council周期性生產(chǎn)回顧 Perio

13、dic Production Review驗(yàn)證回顧報(bào)告 Validation Review Report偏差處理 Deviation Handing持續(xù)改進(jìn)的進(jìn)度通過以下流程來跟蹤和回顧：The progress of the actions is followed and reviewed by:糾正預(yù)防措施系統(tǒng) Corrective action and preventive action system4.4.2. GSKBS根據(jù)國家食品藥品監(jiān)督管理局關(guān)于推動藥品生產(chǎn)企業(yè)實(shí)施藥品質(zhì)量受權(quán)人制度的通 知(國食藥監(jiān)安(2009) 121號)，及滬藥監(jiān)安(2009) 495號的要求，執(zhí)行藥品質(zhì)量

14、受權(quán)人 制度。由質(zhì)量保證部經(jīng)理作為GSKBS質(zhì)量受權(quán)人，經(jīng)企業(yè)法人代表授權(quán)批準(zhǔn)，并提交上海食 品藥品監(jiān)督管理局備案批準(zhǔn)。According to the notice from SFDA(國食藥監(jiān)安(2009) 121 號),and SHFDA 滬藥監(jiān)安(2009) 495 號，GSKBS execute the system of Qualified Person. Manager of quality assurance department is assigned to be QP of GSKBS. He/she is authorized by Corporate Represent

15、ative, and is registered in SHFDA.質(zhì)量受權(quán)人按規(guī)定行使以下職責(zé):The main responsibility of QP is as below負(fù)責(zé)保證企業(yè)質(zhì)量管理體系的有效運(yùn)行Ensure the effectiveness of quality management system負(fù)責(zé)對影響產(chǎn)品質(zhì)量的關(guān)鍵管理活動行使決定權(quán)Final approval for key documentations which could affect product quality對于產(chǎn)品質(zhì)量有重大影響的情況行使否決權(quán)Own the veto right of key pr

16、oceedings參與或負(fù)責(zé)與藥品質(zhì)量相關(guān)的其他工作Participate or response for the works related to product quality負(fù)責(zé)與藥品監(jiān)督管理部門的溝通Responsible for the communication with Food and Drug Administration.Doc. No.: QA004 編號：Version No.: 7.0 版本號Page 12 of 13 頁數(shù)Effective Date:生效日期具體職責(zé)參見相關(guān)法規(guī)文件。Detailed responsibility refer to relevant

17、 regulations.因工作需要，藥品質(zhì)量受權(quán)人可將質(zhì)量管理的局部具體工作轉(zhuǎn)授權(quán)給轉(zhuǎn)受權(quán)人，但藥品質(zhì)量受 權(quán)人必須對轉(zhuǎn)授權(quán)的這局部質(zhì)量管理工作負(fù)責(zé)（即授權(quán)不授責(zé)）。轉(zhuǎn)受權(quán)人具有相應(yīng)專業(yè)技術(shù) 資格和工作經(jīng)驗(yàn)與轉(zhuǎn)授工作內(nèi)容相適應(yīng)的，其培訓(xùn)由藥品質(zhì)量受權(quán)人負(fù)責(zé)組織。轉(zhuǎn)受權(quán)人不得 再次轉(zhuǎn)授權(quán)其他人承當(dāng)相關(guān)工作。To adapt routine work, QP could assign some rights to a deputy. However, QP is the responsible person for these authorizations. The deputy should

18、have suitable certification and experience of relevant warrant. The training for a deputy is organized by QP. The deputy can not assign his/her commission to other people.Biologicals Shanghai Quality Council CommunicationDate:Author:Date/Month/YearDate:Author:TypeDescriptionSuccessesDecisionsIssues

19、and OpportunitiesFor ApprovalGLAXOSMITHKLINE BIOLOGICALS (SHANGHAI) LTD 上海葛蘭素史克生物制品Appendix： 2 附件Doc. No.： QA004Version No.： 7.0Page No.: 1 of 1Effective Date:編號版本號頁數(shù)生效日期Last saved 保存時(shí)間 15/09/2022 11:52 AM變更歷史CHANGE HISTORY編號：QA004Doc. No標(biāo)題：GSKBS質(zhì)量管理體系Title: GSKBS Quality Management System版本號Version

20、 No.生效日期Effective Date變更內(nèi)容Description of Change變更理由(以及可能的技術(shù)變更)Justification of Change (and Technical Change No if 叩plicable)Version 1.0 (QA004)01/04/2001N/ANewVersion 2.0 (QA004/01)10/03/2002More practiceAdd annual quality performance review systemUpdateVersion 3.0 (QA004/02)30/90/2004-content of qu

21、ality performance report-the members of the quality review team -the frequency of the quality issue meetingsMeeting the requirements of the QMSVersion 4.030/06/2006This procedure is modified as GQP chapter 1: management.All the processes and processes KPIs are defined in this procedure.The periodic

22、product review report is added to this report.The monthly quality report is simplified as per the value of the analysis. The cover page of the monthly report is added to the report.The communications are modified as per the changes in GSKBS.All the QA related documents are listed and the review freq

23、uency is clearly defined.As per the GSKBS current practice Harmonization with GQPs Streamline all the processes and KPIs Link to the QA plan but more detailVersion 5.030/05/2008Specify QMS implementation requirements and gap analysis steps/toolsAdd the description of GMP RequirementUpdate the Qualit

24、y Council Meeting CharterComply with QMS requirementsLast saved 保存時(shí)間 15/09/2022 11:52 AM變更歷史CHANGE HISTORY編號：QA004Doc. No標(biāo)題：GSKBS質(zhì)量管理體系Title: GSKBS Quality Management System版本號Version No.生效日期Effective Date變更內(nèi)容Description of Change變更理由(以及可能的技術(shù)變更)Justification of Change (and Technical Change No if 叩pl

25、icable)Version 6.029/04/2010Specify responsibility of different role locally.In 4.1.2.5, detailed description of Difference & Gap，also added the actions must be taken accordingly.In 4.3.1.2, added Organization Chart should be up to date, and should be reviewed at least once a year.In 4.3.1.3, Suppli

26、er Meeting was replaced by Quality issue communication with supplier. Added Quality learning (Remarks, Deviation, Complaint, global alert, FDA inspection result information share).In 4.3.1.5, added The on-going effectiveness of QMS implementation must be assessed through self inspection and monitori

27、ng audits (L2 and L3 audit) where performed.-Comply with GQMP1003 V2.0, GQP2101 V2.0.-To be more practical.Version 7.0Deleted Annex 2 *Site Monthly Reporf which is sent to GQA on a monthly basis.Added 4.3.1.5.6, the purpose of Site Quality Council meetingAdded 4.3.2, the requirement of QP-As the con

28、tent of this monthly report is duplicated Site Quality Council meeting minutes, so GSKBS, Regional QA and GQA get the agreement of cancel this report. The communication will focus on SQC minutes.-L3 audit FND-L3-0167563, CP-2010090-Adapt regulationLast saved 保存時(shí)間 15/09/2022 11:52 AMXXXDoc. No.: QA00

29、4Version No.: 7.0Page 2 of 13Effective Date:編號版本號頁數(shù)生效日期.目的 OBJECTIVE建立一個(gè)結(jié)合管理原那么和GMP要求的質(zhì)量管理體 系，從而為客戶提供好的產(chǎn)品質(zhì)量，符合法規(guī)的要求 并促使xxxx持續(xù)不斷的進(jìn)步。To establish system to integrate the management principle with Good Manufacturing Practice requirement so as to deliver the quality for the customers, compliance for the

30、 regulators and continuous improvement for the GSKBS.范圍 SCOPE此程序適用XXX生物制品內(nèi)所有與質(zhì)量 有關(guān)的操作This procedure applies to all activities related quality throughout GSKBS.職責(zé) RESPONSIBILITIES3.1工廠經(jīng)理應(yīng)-保證足夠的資源以建立、執(zhí)行及維護(hù)工廠的質(zhì)量 體系3.1工廠經(jīng)理應(yīng)-保證足夠的資源以建立、執(zhí)行及維護(hù)工廠的質(zhì)量 體系-指定并授權(quán)QMS倡導(dǎo)者負(fù)責(zé)將QMS的要求有效 地融入工廠質(zhì)量體系保證各部門經(jīng)理在他們管理的區(qū)域執(zhí)行QMSQMS

31、倡導(dǎo)者負(fù)責(zé)管理工廠QMS執(zhí)行的過程質(zhì)量部負(fù)責(zé)建立，維護(hù)以及改進(jìn)質(zhì)量管理體系。 確保QMS執(zhí)行過程中產(chǎn)生的質(zhì)量/符合性風(fēng)險(xiǎn)能 夠很好地被管理所有員工必須遵守質(zhì)量管理體系。管理層負(fù)責(zé)檢查回顧質(zhì)量管理體系的執(zhí)行情 況，并對改進(jìn)質(zhì)量體系提供相應(yīng)的資源3.1工廠經(jīng)理應(yīng)-保證足夠的資源以建立、執(zhí)行及維護(hù)工廠的質(zhì)量 體系-指定并授權(quán)QMS3.1工廠經(jīng)理應(yīng)-保證足夠的資源以建立、執(zhí)行及維護(hù)工廠的質(zhì)量 體系-指定并授權(quán)QMS倡導(dǎo)者負(fù)責(zé)將QMS的要求有效 地融入工廠質(zhì)量體系保證各部門經(jīng)理在他們管理的區(qū)域執(zhí)行QMSQMS倡導(dǎo)者負(fù)責(zé)管理工廠QMS執(zhí)行的過程質(zhì)量部負(fù)責(zé)建立，維護(hù)以及改進(jìn)質(zhì)量管理體系。 確保QMS執(zhí)行過程

32、中產(chǎn)生的質(zhì)量/符合性風(fēng)險(xiǎn)能 夠很好地被管理所有員工必須遵守質(zhì)量管理體系。管理層負(fù)責(zé)檢查回顧質(zhì)量管理體系的執(zhí)行情 況，并對改進(jìn)質(zhì)量體系提供相應(yīng)的資源詳細(xì)職責(zé)參加第四章It is the responsibility of site manager to-Ensure resources are made available to establish, implement and maintain the local quality system.-Assign and empower a QMS Champion to take responsibility for effective inte

33、gration of QMS requirements into the local system.-Ensure department managers implement QMS within their area of accountability.It is the responsibility of QMS Champion to manage local QMS implementation process.It is the responsibility of the quality dept. to establish, maintain and improve the qua

34、lity management system. To ensure quality/compliance risks arising from implementation are appropriately managedIt is the responsibility of all staff to follow the quality management systemIt is the responsibility of management team to review the implementation of quality management system, and prov

35、ide the related resource for its improvement.Refer to chapter 4 for detailed responsibilitiesXXXXXXDoc. No.: QA004Version No.: 7.0Page 3 of 13Effective Date:編號：版本號頁數(shù)生效日期4.步驟 PROCEDURE流程圖 Flowchart/I4.2.1.8. Incident42.1.7.Analytical Controls 分析控制4.3.1.5 Review 回顧Management事件管理一Improve 提高Plan計(jì)劃4.2Goo

36、d Manufacturing4.2.1.2 Personnel k人員4.2.1.1 Management XXXDoc. No.: QA004Version No.: 7.0Page 3 of 13Effective Date:編號：版本號頁數(shù)生效日期4.步驟 PROCEDURE流程圖 Flowchart/I4.2.1.8. Incident42.1.7.Analytical Controls 分析控制4.3.1.5 Review 回顧Management事件管理一Improve 提高Plan計(jì)劃4.2Good Manufacturing4.2.1.2 Personnel k人員4.2.1

37、.1 Management 管理4.1 QMSProcessAssurancel過程保證質(zhì)量管理體系4.3.1.4Measure監(jiān)測4.3.1.2Organize組織4.3.1.3 Communicate 溝通.4.2.1.3Documentatior& Data iri和數(shù)據(jù)44.2.1.5 Material anU1Product Control4物料和產(chǎn)品控制Facilities 設(shè)施Doc. No.: QA004 編號：Version No.: 7.0 版本號Page 4 of 13 頁數(shù)Effective Date:生效日期質(zhì)量管理體系 Quality Management Syst

38、em介紹 Introduction:xxx的質(zhì)量體系是一個(gè)具有生命力的系統(tǒng)，全面的政策，支持的過程和與法規(guī)要求一致的程序，并 在公司內(nèi)部進(jìn)行積極的管理Quality Management system is a living system with comprehensive policies, supported by process and procedure aligned to regulatory requirement and requiring active management in GSKBS該體系的輸入為:Input of this system-Global Requir

39、ements (including GQPs, GQMPs, GSOPs, Global Quality Council Communication and Global Quality Alert)全球要求(包括GQPs, GQMPs, GSOPs,全球質(zhì)量管理會議溝通和質(zhì)量警報(bào)) -Continuous Improvement based on process 基于過程的持續(xù)改進(jìn)-Regulatory Requirements 法規(guī)政策4.2.2.詳細(xì)步驟 Detailed stepID操作步驟(什么)Action (What)誰(職責(zé))Who(func.)控制，指標(biāo)，規(guī)那么(QA, EH

40、S, Fi.)Controls, KPIs, Rules (QA,EHS,Fi.)1.監(jiān)控體系3個(gè)輸入的變化Monitor change of 3 input of QMS質(zhì)量經(jīng)理 Quality Mgr.N/A2.組織差距分析Organize gap analysis.QMS倡導(dǎo)者QMS ChampionQMS差距分析表的編號為GA-年份-序列號，序 歹U 號從 001 開始 The No. of QMS gap analysis form is GA-Year-Serial No., starting from 001.根據(jù)全球QMS的變更情況，填寫QA004-F1的 A局部后交相關(guān)指定人

41、員。Whenever there is any change of global QMS, fill in part A of QA004-F1, and then handover this form to the assigned person.3.執(zhí)行差距分析Perform gap analysisSOP作者或指 定人員SOP author or assigned person分析前，需要從My-Leaming上取得證書，然后 完成QA004-F1的B局部。Before gap analysis, the person must acquire the certificate via m

42、y-learning. Complete the Part B of QA004-F1.4.對差距執(zhí)行風(fēng)險(xiǎn)評估并確認(rèn)行動計(jì) 劃Perform risk assessment of the gap and confirm the action plan執(zhí)行差距分析 人員與相關(guān)部 門經(jīng)理 Related person and Dept. Mgr. who performed gap analysis參見QA053,并填寫QA004-F1的C局部。 Refer to QA053, fill in part C of QA004-F1.對于風(fēng)險(xiǎn)評估認(rèn)為對產(chǎn)品安全、質(zhì)量或有效 性沒有影響者，應(yīng)作為“差異

43、”進(jìn)行記錄， 可以不再采取進(jìn)一步行動。For the differences assessed as having no impact on product safety, quality or efficacy, it should be recorded as a difference. No further action is required.對于風(fēng)險(xiǎn)評估認(rèn)為可能對產(chǎn)品安全、質(zhì)量或 有效性有影響者，那么應(yīng)作為“差距”，必須采Doc. No.: QA004 編號：Version No.: 7.0 版本號Page 5 of 13 頁數(shù)Effective Date:生效日期取進(jìn)一步行動消除差

44、距，降低風(fēng)險(xiǎn)。參見 QA053 和 QA052。For the differences assessed as having potential impact on product safety, quality or efficacy, it should be considered as a gap. Further action must be taken to mitigate the gap and risk. Refer to QA053 & QA052.行動計(jì)劃必須在四個(gè)月內(nèi)制定并完成(QMS 文件預(yù)放行階段一個(gè)月，生效后三個(gè)月，共 計(jì)四個(gè)月)The action plannin

45、g must be scheduled and completed with 4 months. (QMS documentation pre-release one month, 3 months after being effective, 4 months in total).5.監(jiān)控計(jì)劃執(zhí)行的過程Monitor the progress of action planningSOP作者或指 定人員SOP author or assigned person填寫QA004-F1的D局部,并通知QMS倡導(dǎo)者。 Fill in the Part D of QA004-F1, and then i

46、nform QMS Champion.6.確認(rèn)差距已經(jīng)消除Confirm Gap is closedQMS倡導(dǎo)者QMS Champion填寫QA004-F1的E局部Fill in the Part E of QA004-F17.回顧和提高質(zhì)量管理體系執(zhí)行 Review and Improve the Implementation of QMS.管理層 ManagementTeam審計(jì)(自檢，內(nèi)審和全球?qū)徲?jì))Audit (self-inspection, internal and global audit)-定期回顧Periodic Review優(yōu)良藥品生產(chǎn)管理規(guī)范Good Manufactur

47、ing Practice介紹 Introduction優(yōu)良藥品生產(chǎn)管理規(guī)范是藥品牛.產(chǎn)的最低要求，也是確定我們做正確的事，并正確地做事的過程. Good Manufacturing Practice is the regulatory requirement for drug manufacturing, and a process to ensuring that we do right things, and do things right.從八個(gè)方面進(jìn)行介紹 Introduce GMP from eight sections:管理 Management人員 Personnel文件和數(shù)據(jù)

48、Documentation & Data設(shè)施 Facilities物料與產(chǎn)品控制 Material and Product Control過程保證 Process Assurance分析控制 Analytical Controls事件管理 Incident ManagementDoc. No.: QA004 編號：Version No.: 7.0 版本號Page 6 of 13 頁數(shù)Effective Date:生效日期所有有關(guān)的文件可以參考S:SOPControlled Documents。All those information could reference S:SOPControll

49、ed Documents.詳細(xì)步驟 Detailed steps: N/A管理原那么 Management Principle介紹 Introduction六大管理原那么是質(zhì)量管理體系中必不可少的局部：Six Management Principles are essential to Quality Management System計(jì)戈ij Planning組織 Organizing溝通 Communicating監(jiān)測 Measuring回顧 Reviewing提高 Improving計(jì)劃 Planning計(jì)劃是保證質(zhì)量完全地被融入到公司組織戰(zhàn)略，運(yùn)營計(jì)劃和商業(yè)流程中。上海工廠的計(jì)劃有 以

50、下幾種：Planning is to ensure quality is full integrated into the organizations strategic and operational planning and business processes. The plans in GSKBS are as follows:上海工廠戰(zhàn)略 GSKBS Alignment Grid質(zhì)量計(jì)戈iJ Quality Plan風(fēng)險(xiǎn)管理(風(fēng)險(xiǎn)降低計(jì)劃)Risk Management (mitigation plan)驗(yàn)證主計(jì)劃 Validation Master Plan培訓(xùn)計(jì)劃 Trainin

51、g Plan審計(jì)計(jì)劃(自檢和內(nèi)審)Audit Plan (Self Inspection & Internal Audit Plan)供應(yīng)商和分銷商審計(jì)計(jì)劃Supplier and Distributor Audit Plan預(yù)防性維修和校驗(yàn)計(jì)劃 Preventive Maintenance & Calibration Plan通過這些計(jì)劃，將質(zhì)量的目標(biāo)和目的貫穿到整個(gè)組織機(jī)構(gòu)中Through those plans, ensure quality goals and objectives are cascaded down throughout the organization.組.織 Or

52、ganizing組織通過提供必要財(cái)力，物力和人力來保證及時(shí)的按照有關(guān)質(zhì)量要求的完成商業(yè)和運(yùn)營計(jì)劃 Organizing is to provide required financial, material and human resources to ensure complete and timely delivery of the business plan and operational compliance with all relevant quality requirements.Doc. No.: QA004 編號：Version No.: 7.0 版本號Page 7 of 13

53、 頁數(shù)Effective Date:生效日期上海工廠的質(zhì)量部是獨(dú)立的部門，以確保其可以獨(dú)立及客觀地行使質(zhì)量控制職責(zé)。參見工廠 的組織結(jié)構(gòu)圖，該組織結(jié)構(gòu)圖應(yīng)該是實(shí)時(shí)更新的，且至少每年回顧一次。The Quality Department is independent in GSKBS. The organizational structure must allow the local quality organization to have the necessary independence and objectivity in the performance of its quality r

54、esponsibilities. Refer to Site Organization Chart. This Organization Chart should be up to date, and should be reviewed at least once a year.質(zhì)量和GMP的職責(zé)個(gè)人職責(zé)描述和個(gè)人開展計(jì)劃中定義了。The responsibilities for implementing and maintaining quality and GMP are well defined in individual job description and Personnel D

55、evelopment Plan.溝通 Communicating有效的溝通能促進(jìn)質(zhì)量意識的提高，并且鼓勵和取得每個(gè)人員在質(zhì)量上的承諾Effective communication is essential to promote awareness of quality and to encourage and secure the commitment of everyone to quality 當(dāng)前工廠的溝通機(jī)制有以下幾種The current communication mechanisms in GSKBS are-工廠質(zhì)量部與其他部門的溝通-Communication between

56、 GSKBS QA and other departments:類型Type內(nèi)容Subject頻率Frequency參與者 Participants質(zhì)量QA/RA價(jià)值鏈VS技術(shù)服務(wù)/ 商務(wù) TS/BSEHS工廠 Site培訓(xùn)Training藥品質(zhì)量管理規(guī)范GMP fresh training至少每年一次Atleast once a year全體All全體All全體All全體All經(jīng)理Mgr文件 Documentation視情況而定Attend upon request視情況而定 Attend upon request視情況而定 Attendupon request視情況而定 Attendupo

57、n request視情況而定 Attendupon request視情況而定 Attendupon requestQuality learning (Remarks, Deviation, Complaint, global alert, FDA inspection result information share)視情況而定 Attend upon request視情況而定 Attend upon request視情況而定Attend upon request視情況而定Attend upon request視情況而定 Attendupon request視情況而定Attend upon r

58、equest質(zhì)量部會議QA Meeting質(zhì)量執(zhí)行狀態(tài)和計(jì)劃Quality Implementation Status and Planning至少每月一次At least once a month全體All視情況而定Attend upon request視情況而定Attend upon request視情況而定Attend upon request視情況而定Attend upon request質(zhì)量管理會議Quality Council Meeting詳見附件1Refer to Appendix 1每月一次 Monthly經(jīng)理Mgr經(jīng)理Mgr經(jīng)理Mgr經(jīng)理Mgr經(jīng)理Mgr全體員工會議Staf

59、f Meeting質(zhì)量情況報(bào)告&質(zhì)量管 理體系報(bào)告Quality Status ReportQMS Status Report每季度一次Quarterly全體All全體All全體All全體All全體All-工廠質(zhì)量部與Biological全球質(zhì)量部的溝通-Communication between GSKBS QA and Biological Global Quality Function:Doc. No.: QA004 編號：Version No.: 7.0 版本號Page 8 of 13 頁數(shù)Effective Date:生效日期類型Type內(nèi)容Subject頻率Frequency參與者

60、Participants質(zhì)量管理會議溝通Quality Council Communication工廠質(zhì)量管理會議紀(jì)要或附件2 Refer to Site QC Meeting Minutes or Appendix 2每月一次 會 議或使用附件2 Monthly TC or by Appendix 2GSKBIO 全球 QAGSK-BIO Global QA質(zhì)量警報(bào)Quality Alert提供全球特定質(zhì)量問題Sharing global specific quality issues視情況而定Attend upon requestGSKBIO 全球 QAGSK-BIO Global QA審