供應(yīng)商審計(jì)管理規(guī)程

1、1. Purpose目的 異常情況處理：如供應(yīng)商斷貨，物料異常等To establish a procedure for evaluation and approval of vendors for procurement of raw materials and packaging materials required for manufacturing and packing of finished products.建立對(duì)成品生產(chǎn)所需原輔料以及包裝材料供應(yīng)商的資質(zhì)進(jìn)行審查和批準(zhǔn)的流程。2. Scope范圍 This is applicable for approval of all ve

2、ndors supplying raw materials and packaging materials to the site.適用于廠區(qū)所有原輔料以及包裝材料供應(yīng)商的批準(zhǔn)3. Responsibility 職責(zé) QA：Materials quality 質(zhì)量保證部：負(fù)責(zé)物料的質(zhì)量控制Purchase Department: materials purchase物料采購(gòu)部：負(fù)責(zé)物料的采購(gòu)QC: materials testing質(zhì)量控制部：負(fù)責(zé)物料的檢測(cè)Production: product manufacturing 生產(chǎn)部：負(fù)責(zé)物料的試用4. Definition 定義Vendor:

3、Manufacturer / Supplier of Raw materials and Packaging materials.供應(yīng)商：原輔料以及包裝材料的生產(chǎn)廠家或供貨商。5. Safety Precaution安全注意事項(xiàng)None無(wú)6. Procedure規(guī)程6.1 General 通則6.1.1 Approved vendor list (AVL) shall be maintained for Active Pharmaceutical Ingredients (API), excipients and packing materials. This shall be prepare

4、d by QA, and approved by QA Manager as per Annexure VI for raw material (RM) and Annexure VII packaging material (PM) respectively. The Approved Vendor List shall be numbered as AVL/RM/01 for raw material (RM) and AVL/PM/01 for packing material (PM), where 01 indicates the Revision No. starting from

5、 01.批準(zhǔn)的供應(yīng)商列表”（AVL）應(yīng)包括原料（API），輔料以及包裝材料的供應(yīng)商。該列表由QA人員起草，并由QA經(jīng)理按附件六對(duì)原輔料（RM）和附件七包裝材料（PM）供應(yīng)商進(jìn)行批準(zhǔn)。批準(zhǔn)的供應(yīng)商列表應(yīng)該按照原輔料和包裝材料分別命名為AV/RM/01，AV/PM/01。其中01代表修訂的版本號(hào)，從01開(kāi)始。6.2 Whenever there is a need for introducing new vendor, Purchase department shall identify the manufacturer/supplier for the required raw material

6、 or packaging material and inform the QA.如果需要添加新的供應(yīng)商時(shí)，采購(gòu)部門(mén)應(yīng)當(dāng)確定原輔料以及包裝材料的生產(chǎn)商或供應(yīng)商，并通知QA經(jīng)理。6.3 QA manager in co-ordination with Purchase department shall arrange for the following from the vendor:QA經(jīng)理應(yīng)和采購(gòu)部門(mén)應(yīng)安排供應(yīng)商提供下列資料：6.3.1 Technical data package (for API only) (as per Annexure X).技術(shù)資料包（只針對(duì)API，附錄 X）6.

7、3.2 a) Filled Questionnaire for vendor evaluation of Raw Materials Refer Annexure I , Questionnaire for TSE Refer Annexure II which is as per current regulatory requirement including local and EU guideline. The questionnaire is grouped under the following: General information, organization, personne

8、l & training, building and facilities, equipment, Documentation & records, Material management, Laboratory, Quality management system, Environment, safety & hygiene, warehouse, Production and process controls, packaging & labeling controls and transportation.填寫(xiě)附件一原料供應(yīng)商評(píng)估的調(diào)查問(wèn)卷，附件二TSE調(diào)

9、查問(wèn)卷，該問(wèn)卷是遵循本地以及歐盟現(xiàn)行法規(guī)要求。調(diào)查問(wèn)卷包括以下幾大類(lèi)：基本信息，組織結(jié)構(gòu)，人員培訓(xùn)，廠房設(shè)施，儀器設(shè)備，文件記錄，物料管理，實(shí)驗(yàn)室，質(zhì)量管理體系，環(huán)境，安全與衛(wèi)生，倉(cāng)庫(kù)，生產(chǎn)以及工藝控制，包裝以及標(biāo)簽的管理和運(yùn)輸。b) Filled Questionnaire for vendor evaluation of Packaging materials Refer Format Annexure III.填寫(xiě)附件三包裝材料供應(yīng)商評(píng)估的調(diào)查問(wèn)卷。.The vendor evaluation questionnaires can be sent as a hard copy or so

10、ft copy. If sent as soft copy, the effective date, issue date and issued by detail shall be typed.供應(yīng)商的調(diào)查問(wèn)卷可以以紙質(zhì)或電子版本形式發(fā)送。如果以電子版本形式發(fā)送，文件的生效日期，發(fā)放日期等都應(yīng)當(dāng)注明。6.3.3 The vendor shall fill the questionnaire and forward to QA manager for evaluation.供應(yīng)商應(yīng)當(dāng)填寫(xiě)調(diào)查問(wèn)卷，并反饋給QA經(jīng)理以便進(jìn)行評(píng)估。6.3.4 QA manager shall evaluate fi

11、lled questionnaire along with technical data package.QA經(jīng)理應(yīng)當(dāng)根據(jù)技術(shù)資料包和填寫(xiě)的調(diào)查問(wèn)卷進(jìn)行評(píng)估。6.4 Approval of vendor for API API供應(yīng)商的批準(zhǔn)。6.4.1 The approval and disapproval of API vendor shall be done by auditing the facility.審計(jì)完API供應(yīng)商的工廠后再?zèng)Q定是否批準(zhǔn)或不批準(zhǔn)。 QA manager shall evaluate the filled questionnaire, if not satisfa

12、ctory, vendor shall be rejected and intimated to purchase department.QA經(jīng)理應(yīng)當(dāng)評(píng)估供應(yīng)商所填寫(xiě)的調(diào)查問(wèn)卷，如果不符合要求，應(yīng)當(dāng)取消其資格并通知采購(gòu)部門(mén)。6.4.3 If found satisfactory, shall recommend for facility audit, the Purchase Department shall arrange for the same and communicate to QA manager who shall depute a person/s for conducting

13、 the audit. The auditor/(s) shall inspect the site as per Annexure VIII audit checklist for API and check for compliance of the filled questionnaire as per cGMP requirement.如果供應(yīng)商符合要求，應(yīng)當(dāng)建議對(duì)其進(jìn)行審計(jì)，采購(gòu)部門(mén)進(jìn)行安排并和QA經(jīng)理進(jìn)行溝通。QA經(jīng)理指定人員負(fù)責(zé)審計(jì)工作。審計(jì)員應(yīng)當(dāng)按照附件八原料檢查清單對(duì)工廠進(jìn)行審計(jì)，還需要檢查所填寫(xiě)的問(wèn)卷內(nèi)容是否和現(xiàn)場(chǎng)條件一致，是否符合cGMP的要求。Incase of man

14、ufacturer from overseas, audit may be arranged to be conducted by outsourcing a competent person. The competency of the contracted auditor shall be decided by PL holder/QP. The curriculum vitae of the contracted auditor shall be sent to PL holder/QP for their necessary approval.對(duì)于國(guó)外的生產(chǎn)廠家，審計(jì)工作可以安排一名有

15、資質(zhì)的人員進(jìn)行。審計(jì)員的資質(zhì)由產(chǎn)品證書(shū)所有者或QP來(lái)確定。該人員的履歷應(yīng)發(fā)送給PL持有者以及QP進(jìn)行批準(zhǔn)。6.4.4 The auditor/s shall prepare the vendor facility audit report as per Annexure V to indicate the points which are in compliance and also cGMP shortfalls/non-compliance /deficiencies noted during the audit if any and corrective actions agreed,

16、compliance report. The report should also state the GMP standard followed by the vendor. For Ex.: EU-GMP, WHO, ICH, FDA, etc. .審計(jì)員應(yīng)當(dāng)按照附件五準(zhǔn)備供應(yīng)商工廠的審計(jì)報(bào)告，打分點(diǎn)應(yīng)體現(xiàn)出廠房是否符合cGMP要求，如果有，還應(yīng)注明審計(jì)中發(fā)現(xiàn)的缺陷或不符合性，以及采取的整改措施和報(bào)告。報(bào)告還應(yīng)體現(xiàn)出供應(yīng)商所遵循的GMP標(biāo)準(zhǔn)，例如：歐盟GMP，WHO，ICH， FDA等。6.4.5 QA manager shall review the above data and if

17、found satisfactory shall approve the vendor.QA經(jīng)理應(yīng)當(dāng)審核以上數(shù)據(jù)，如果合格就批準(zhǔn)其為合格供應(yīng)商。Note In case of contract givers product, the audit report shall be sent to QP for review. Based on the QPs recommendation, the vendors shall be evaluated.備注：如果是合同加工產(chǎn)品，審計(jì)報(bào)告還應(yīng)發(fā)送給QP，請(qǐng)其審核。根據(jù)QP的建議對(duì)供應(yīng)商進(jìn)行評(píng)估。6.4.6 QA manager shall infor

18、m the approval of new vendor to Stores, QC and Purchase through New Vendor Approval Intimation format: Annexure IV. The Approved vendor list shall be updated once in three months, in the meantime if any new vendor is included the same shall be intimated through New Vendor Approval Intimation format:

19、 Annexure IV.QA經(jīng)理應(yīng)當(dāng)及時(shí)將附件四新批準(zhǔn)供應(yīng)商通知的信息下發(fā)給倉(cāng)庫(kù)，QC和采購(gòu)部門(mén)。批準(zhǔn)的供應(yīng)商列表應(yīng)當(dāng)每季度更新一次，同時(shí)如果有任何新的供應(yīng)商被批準(zhǔn)，都應(yīng)當(dāng)下發(fā)附件四新批準(zhǔn)供應(yīng)商通知進(jìn)行通知。4.7 6.The vendor shall provide Certificate of Analysis for each consignment and TSE/BSE Declaration Certificate once in a year. In case of animal origin material the vendor shall provide TSE/BSE

20、Free Certificate / Declaration along with each consignment supplied.供應(yīng)商都應(yīng)當(dāng)提供每批貨物的COA，一年更新一次TSE/BSE證明。若是動(dòng)物來(lái)源的產(chǎn)品，每批貨物供應(yīng)商都應(yīng)當(dāng)附上無(wú)TES/BSE證明。6.4.8 In case of change in site of manufacture, the vendor shall notify about the change before supplying first consignment from new site.如果生產(chǎn)場(chǎng)地發(fā)生了變更，供應(yīng)商應(yīng)當(dāng)在提供新場(chǎng)地生產(chǎn)的第一

21、批貨之前，通知相關(guān)的變更。Note: This information is sent to the Product License (PL) holders for their necessary approval.備注：該信息應(yīng)當(dāng)發(fā)送給產(chǎn)品證書(shū)所有者進(jìn)行審核、批準(zhǔn)。6.5 Approval of Vendor for Excipients and Packaging Materials 輔料以及包裝材料供應(yīng)商的批準(zhǔn)。6.5.1 The approval and disapproval of the excipients and secondary packing material vend

22、or shall be done by sending the questionnaire.輔料以及外包材的供應(yīng)商可以通過(guò)調(diào)查問(wèn)卷來(lái)決定是否批準(zhǔn)其為合格供應(yīng)商。6.5.2 QA shall evaluate the filled questionnaire received from the vendor of raw material (excipients) as per Format Annexure I, Annexure II and packaging material as per Format Annexure III.QA應(yīng)當(dāng)評(píng)價(jià)由輔料以及包裝材料供應(yīng)商提交的調(diào)查問(wèn)卷，分別為

23、附件一，附件二和附件三。.6.6 Approval of vendor for primary and printed packing materials 內(nèi)包材和印刷包裝材料供應(yīng)商的批準(zhǔn)6.6.1 The approval and disapproval of primary and printed packing materials vendor shall be done by auditing the facility.通過(guò)工廠審計(jì)來(lái)決定內(nèi)包材以及印刷材料的供應(yīng)商是否為合格供應(yīng)商。6.6.2 QA manager shall evaluate the filled questionna

24、ire, if not satisfactory, vendor shall be rejected and intimated to purchase department.QA經(jīng)理應(yīng)當(dāng)審核對(duì)方所提供的調(diào)查問(wèn)卷，如果不符合要求，應(yīng)當(dāng)不予通過(guò)并及時(shí)通知采購(gòu)部門(mén)。6.6.3 If found satisfactory, shall recommend for facility audit, the Purchase Department shall arrange for the same and communicate to QA manager who shall depute a pers

25、on/s for conducting the audit. The auditor/(s) shall inspect the site as per Annexure IX the audit checklist for packing materials and check for compliance of the filled questionnaire as per cGMP requirement.如果評(píng)估結(jié)果符合要求，QA應(yīng)當(dāng)建議進(jìn)行工廠審計(jì)，采購(gòu)部門(mén)進(jìn)行安排并和QA經(jīng)理進(jìn)行溝通。QA經(jīng)理指定人員負(fù)責(zé)審計(jì)工作。審計(jì)員應(yīng)當(dāng)按照附件九包材審計(jì)檢查清單對(duì)工廠進(jìn)行審計(jì)，還需要檢查所填寫(xiě)

26、的問(wèn)卷內(nèi)容是否和現(xiàn)場(chǎng)條件一致，是否符合cGMP的要求。6.6.4 The auditor/s shall prepare the vendor facility audit report as per Annexure V to indicate the points which are in compliance and also cGMP shortfalls/non-compliance /deficiencies noted during the audit if any and corrective actions agreed, compliance report. The rep

27、ort should also state the GMP standard followed by the vendor. 審計(jì)員應(yīng)當(dāng)按照附件五準(zhǔn)備供應(yīng)商工廠的審計(jì)報(bào)告，打分點(diǎn)應(yīng)體現(xiàn)出廠房是否符合cGMP要求，如果有，還應(yīng)注明審計(jì)中發(fā)現(xiàn)的缺陷或不符合性，以及采取的整改措施和報(bào)告。報(bào)告還應(yīng)體現(xiàn)出供應(yīng)商所遵循的GMP標(biāo)準(zhǔn)。6.6.5 QA manager shall review the above data and if found satisfactory shall approve the vendor.QA經(jīng)理應(yīng)當(dāng)審核以上數(shù)據(jù)，如果合格就對(duì)供應(yīng)商進(jìn)行批準(zhǔn)。6.7 Vendor Disco

28、ntinuation: 中斷和供應(yīng)商的合作關(guān)系6.7.1 Vendor shall be discontinued based on the criticality of the observations.根據(jù)觀察結(jié)果決定是否繼續(xù)合作6.7.1.1 Critical 關(guān)鍵6.7.1.1.1If do not comply with Approved Specification / Pharmacopoeial requirement / EDQM requirement. If observed during testing, it shall be handled as per XX-SOP

29、-QA038 Handling of Out of specification (OOS) test results.如果檢查過(guò)程中發(fā)現(xiàn)不符合已批準(zhǔn)的標(biāo)準(zhǔn)或藥典標(biāo)準(zhǔn)或EDQM標(biāo)準(zhǔn)，該情況按照X-SOP-QA038OOS管理規(guī)程進(jìn)行處理。6.7.1.1.2 Vendor has made change(s) in the process without informing to Yiling which is identified during reaudit or at any occurrence. 再審計(jì)過(guò)程中或者其他情況下發(fā)現(xiàn)，供應(yīng)商產(chǎn)品工藝發(fā)生了變更，但沒(méi)有通知XX。 Vendor m

30、anufactures the material at a site, which is not approved by Yiling which is identified during reaudit or at any occurrence.再審計(jì)過(guò)程中或者其他情況下發(fā)現(xiàn)，供應(yīng)商產(chǎn)品在未經(jīng)我方批準(zhǔn)的場(chǎng)地進(jìn)行生產(chǎn)。 Disapproval as per Product holder recommendations.產(chǎn)品證書(shū)所有者提出的取消其供應(yīng)商資格。6.7.1.2 The vendor shall be communicated immediately for the respectiv

31、e issues. Based on the reply and action taken by the vendor, QA manager shall decide whether to continue or not with the vendor. If decided not to continue with the vendor, the vendor shall be disqualified and removed from the approved vendor list immediately. The same shall be communicated to Produ

32、ct License (PL) holders.發(fā)現(xiàn)問(wèn)題應(yīng)及時(shí)與供應(yīng)商進(jìn)行溝通。根據(jù)供應(yīng)商的回復(fù)以及所采取的措施，QA經(jīng)理決定是否繼續(xù)和其合作。如果決定不再合作，應(yīng)將該供應(yīng)商列為資質(zhì)不符合，并立即從批準(zhǔn)的供應(yīng)商列表中刪除。同樣，該信息也應(yīng)和產(chǎn)品證書(shū)所有者進(jìn)行溝通。Note 1: Vendor shall be re-qualified only after the satisfactory facility audit report. 備注1：只有工廠審計(jì)報(bào)告合格后，供應(yīng)商才可以重新獲得資質(zhì)；Note 2: In case of contract givers product, prior a

33、pproval from Product License (PL) holder shall be obtained before audit for requalification. 備注2：如果是合同加工項(xiàng)目，對(duì)供應(yīng)商進(jìn)行資格再審查之前應(yīng)先獲得產(chǎn)品證書(shū)所有者的批準(zhǔn)。Critical issues shall be closed within 30 working days. In case of overseas vendor, the time could be extended to another 15 working days.關(guān)鍵性問(wèn)題應(yīng)該在30個(gè)工作日內(nèi)完成，若涉及到海外的供應(yīng)

34、商，可再延長(zhǎng)15個(gè)工作日。6.7.1.3 Major主要的6.7.1.3.1 If audit compliance report of the vendor is not justifiable.如果供應(yīng)商的審計(jì)報(bào)告顯示和現(xiàn)實(shí)不符合；6.7.1.3.2 If corrective action not taken or the corrective action taken also not justifiable. 如果未采取整改措施，或采取的整改措施不恰當(dāng)；.3 Trend data reveals reoccurrence of Quality problems.(Reoccurren

35、ce Repetitive in three months)數(shù)據(jù)趨勢(shì)分析發(fā)現(xiàn)質(zhì)量問(wèn)題反復(fù)發(fā)生（反復(fù)-3個(gè)月內(nèi)重復(fù)發(fā)生）；6.7.1.3.4 If extraneous material (like black particles) found in the material.如果在物料中發(fā)現(xiàn)了異物（如黑色的顆粒）；6.7.1.3.5 Documents provided for the material by the vendor are not as per agreed norms.供應(yīng)商提供的物料相關(guān)的文件與以前的格式不符；6.7.1.3.6 Vendor frequently fail

36、s to supply the material as per committed scheduled time,供應(yīng)商經(jīng)常不能按時(shí)供貨；6.7.1.3.7 If vendor fails to meet the requirement after warning.警告后供應(yīng)商仍不能達(dá)到相關(guān)要求；6.7.1.3.8 If more than three major on a particular material (repetitive in three months) from the same vendor shall be treated as critical.如果來(lái)自同一個(gè)供應(yīng)商的一

37、種物料發(fā)生了三種以上的常見(jiàn)問(wèn)題（3個(gè)月內(nèi)重復(fù)發(fā)生）就應(yīng)當(dāng)被視為關(guān)鍵問(wèn)題。6.7.1.3.9 Out of trend results 偏離趨勢(shì)的結(jié)果6.7.1.4 The vendor shall be communicated immediately for the respective issues. Based on the reply and action taken by the vendor, the vendor shall be warned and site audit may be required.應(yīng)當(dāng)及時(shí)和各供應(yīng)商溝通他們所存在的問(wèn)題，根據(jù)他們的回復(fù)以及所采取的措施，決

38、定是給予警告還是需要進(jìn)行再審計(jì)Major issues shall be closed within 60 working days.主要問(wèn)題應(yīng)當(dāng)在60個(gè)工作日內(nèi)解決。6.7.1.5 Minor微小的6.7.1.5.1 Other than the above circumstances, any other issues arising shall be treated as minor.除了上述問(wèn)題，其余問(wèn)題均被認(rèn)為是次要的問(wèn)題。6.7.2 During course of evaluation/reauditing, if any information provided by the

39、vendor is found untrue/false or misleading or any change carried out is not informed in writing the vendor shall be disqualified after proper investigation.在再審計(jì)和評(píng)估的過(guò)程中，如果供應(yīng)商提供的信息一旦被發(fā)現(xiàn)是不真實(shí)的、錯(cuò)誤的、誤導(dǎo)性的或發(fā)生了沒(méi)有聲明的變更，在經(jīng)過(guò)調(diào)查確認(rèn)后，可撤銷(xiāo)該供應(yīng)商的資質(zhì)。6.7.3 If any vendor is disqualified the approved vendor list shall be u

40、pdated immediately and the revised copy shall be circulated to the concerned department.任何供應(yīng)商的資質(zhì)被撤消后，批準(zhǔn)的供應(yīng)商列表應(yīng)及時(shí)更新，并將更新后的版本發(fā)放給各相關(guān)部門(mén)。6.7.4 If any material is rejected due to quality issues, it shall be handled as per the procedure X-SOP-QA038 Handling of Out of Specification (OOS) test results. 如果有物料由于質(zhì)量問(wèn)題被退回，這種情況應(yīng)當(dāng)按照X-SOP-QA038 OOS管理規(guī)程進(jìn)行處理。6.8 Vendor audit reports shall be numbered as follows: No. VR/XX/YY001Where, VR indicates Vendor audit reports, XX indicates RM / PM for Raw Material and Packaging Material respectively. YY indicates last 2 digit of year eg. 10 indicates 2010, 001 in