供應商審計管理規(guī)程.doc

德信誠培訓網(wǎng)供應商審計管理規(guī)程1. Purpose目的 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.建立對成品生產(chǎn)所需原輔料以及包裝材料供應商的資質(zhì)進行審查和批準的流程。2. Scope范圍 This is applicable for approval of all vendors 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商的批準3. Responsibility 職責 QA：Materials quality 質(zhì)量保證部：負責物料的質(zhì)量控制Purchase Department: materials purchase物料采購部：負責物料的采購QC: materials testing質(zhì)量控制部：負責物料的檢測Production: product manufacturing 生產(chǎn)部：負責物料的試用4. Definition 定義Vendor: Manufacturer / Supplier of Raw materials and Packaging materials.供應商：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None無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 prepared 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 01.批準的供應商列表”（AVL）應包括原料（API），輔料以及包裝材料的供應商。該列表由QA人員起草，并由QA經(jīng)理按附件六對原輔料（RM）和附件七包裝材料（PM）供應商進行批準。批準的供應商列表應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，從01開始。6.2 Whenever there is a need for introducing new vendor, Purchase department shall identify the manufacturer/supplier for the required raw material or packaging material and inform the QA.如果需要添加新的供應商時，采購部門應當確定原輔料以及包裝材料的生產(chǎn)商或供應商，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)理應和采購部門應安排供應商提供下列資料：6.3.1 Technical data package (for API only) (as per Annexure X).技術資料包（只針對API，附錄 X）6.3.2 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, personnel & 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.填寫附件一原料供應商評估的調(diào)查問卷，附件二TSE調(diào)查問卷，該問卷是遵循本地以及歐盟現(xiàn)行法規(guī)要求。調(diào)查問卷包括以下幾大類：基本信息，組織結構，人員培訓，廠房設施，儀器設備，文件記錄，物料管理，實驗室，質(zhì)量管理體系，環(huán)境，安全與衛(wèi)生，倉庫，生產(chǎn)以及工藝控制，包裝以及標簽的管理和運輸。b) Filled Questionnaire for vendor evaluation of Packaging materials Refer Format Annexure III.填寫附件三包裝材料供應商評估的調(diào)查問卷。.The vendor evaluation questionnaires can be sent as a hard copy or soft copy. If sent as soft copy, the effective date, issue date and issued by detail shall be typed.供應商的調(diào)查問卷可以以紙質(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)放日期等都應當注明。6.3.3 The vendor shall fill the questionnaire and forward to QA manager for evaluation.供應商應當填寫調(diào)查問卷，并反饋給QA經(jīng)理以便進行評估。6.3.4 QA manager shall evaluate filled questionnaire along with technical data package.QA經(jīng)理應當根據(jù)技術資料包和填寫的調(diào)查問卷進行評估。6.4 Approval of vendor for API API供應商的批準。6.4.1 The approval and disapproval of API vendor shall be done by auditing the facility.審計完API供應商的工廠后再決定是否批準或不批準。6.4.2 QA manager shall evaluate the filled questionnaire, if not satisfactory, vendor shall be rejected and intimated to purchase department.QA經(jīng)理應當評估供應商所填寫的調(diào)查問卷，如果不符合要求，應當取消其資格并通知采購部門。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 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.如果供應商符合要求，應當建議對其進行審計，采購部門進行安排并和QA經(jīng)理進行溝通。QA經(jīng)理指定人員負責審計工作。審計員應當按照附件八原料檢查清單對工廠進行審計，還需要檢查所填寫的問卷內(nèi)容是否和現(xiàn)場條件一致，是否符合cGMP的要求。Incase of manufacturer 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.對于國外的生產(chǎn)廠家，審計工作可以安排一名有資質(zhì)的人員進行。審計員的資質(zhì)由產(chǎn)品證書所有者或QP來確定。該人員的履歷應發(fā)送給PL持有者以及QP進行批準。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, compliance report. The report should also state the GMP standard followed by the vendor. For Ex.: EU-GMP, WHO, ICH, FDA, etc. .審計員應當按照附件五準備供應商工廠的審計報告，打分點應體現(xiàn)出廠房是否符合cGMP要求，如果有，還應注明審計中發(fā)現(xiàn)的缺陷或不符合性，以及采取的整改措施和報告。報告還應體現(xiàn)出供應商所遵循的GMP標準，例如：歐盟GMP，WHO，ICH， FDA等。6.4.5 QA manager shall review the above data and if found satisfactory shall approve the vendor.QA經(jīng)理應當審核以上數(shù)據(jù)，如果合格就批準其為合格供應商。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，審計報告還應發(fā)送給QP，請其審核。根據(jù)QP的建議對供應商進行評估。6.4.6 QA manager shall inform 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: Annexure IV.QA經(jīng)理應當及時將附件四新批準供應商通知的信息下發(fā)給倉庫，QC和采購部門。批準的供應商列表應當每季度更新一次，同時如果有任何新的供應商被批準，都應當下發(fā)附件四新批準供應商通知進行通知。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 Free Certificate / Declaration along with each consignment supplied.供應商都應當提供每批貨物的COA，一年更新一次TSE/BSE證明。若是動物來源的產(chǎn)品，每批貨物供應商都應當附上無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)場地發(fā)生了變更，供應商應當在提供新場地生產(chǎn)的第一批貨之前，通知相關的變更。Note: This information is sent to the Product License (PL) holders for their necessary approval.備注：該信息應當發(fā)送給產(chǎn)品證書所有者進行審核、批準。6.5 Approval of Vendor for Excipients and Packaging Materials 輔料以及包裝材料供應商的批準。6.5.1 The approval and disapproval of the excipients and secondary packing material vendor shall be done by sending the questionnaire.輔料以及外包材的供應商可以通過調(diào)查問卷來決定是否批準其為合格供應商。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應當評價由輔料以及包裝材料供應商提交的調(diào)查問卷，分別為附件一，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商的批準6.6.1 The approval and disapproval of primary and printed packing materials vendor shall be done by auditing the facility.通過工廠審計來決定內(nèi)包材以及印刷材料的供應商是否為合格供應商。6.6.2 QA manager shall evaluate the filled questionnaire, if not satisfactory, vendor shall be rejected and intimated to purchase department.QA經(jīng)理應當審核對方所提供的調(diào)查問卷，如果不符合要求，應當不予通過并及時通知采購部門。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 person/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.如果評估結果符合要求，QA應當建議進行工廠審計，采購部門進行安排并和QA經(jīng)理進行溝通。QA經(jīng)理指定人員負責審計工作。審計員應當按照附件九包材審計檢查清單對工廠進行審計，還需要檢查所填寫的問卷內(nèi)容是否和現(xiàn)場條件一致，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 report should also state the GMP standard followed by the vendor. 審計員應當按照附件五準備供應商工廠的審計報告，打分點應體現(xiàn)出廠房是否符合cGMP要求，如果有，還應注明審計中發(fā)現(xiàn)的缺陷或不符合性，以及采取的整改措施和報告。報告還應體現(xiàn)出供應商所遵循的GMP標準。6.6.5 QA manager shall review the above data and if found satisfactory shall approve the vendor.QA經(jīng)理應當審核以上數(shù)據(jù)，如果合格就對供應商進行批準。6.7 Vendor Discontinuation: 中斷和供應商的合作關系6.7.1 Vendor shall be discontinued based on the criticality of the observations.根據(jù)觀察結果決定是否繼續(xù)合作6.7.1.1 Critical 關鍵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-QA038 Handling of Out of specification (OOS) test results.如果檢查過程中發(fā)現(xiàn)不符合已批準的標準或藥典標準或EDQM標準，該情況按照X-SOP-QA038OOS管理規(guī)程進行處理。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. 再審計過程中或者其他情況下發(fā)現(xiàn)，供應商產(chǎn)品工藝發(fā)生了變更，但沒有通知XX。6.7.1.1.3 Vendor manufactures the material at a site, which is not approved by Yiling which is identified during reaudit or at any occurrence.再審計過程中或者其他情況下發(fā)現(xiàn)，供應商產(chǎn)品在未經(jīng)我方批準的場地進行生產(chǎn)。6.7.1.1.4 Disapproval as per Product holder recommendations.產(chǎn)品證書所有者提出的取消其供應商資格。6.7.1.2 The vendor shall be communicated immediately for the respective 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 Product License (PL) holders.發(fā)現(xiàn)問題應及時與供應商進行溝通。根據(jù)供應商的回復以及所采取的措施，QA經(jīng)理決定是否繼續(xù)和其合作。如果決定不再合作，應將該供應商列為資質(zhì)不符合，并立即從批準的供應商列表中刪除。同樣，該信息也應和產(chǎn)品證書所有者進行溝通。Note 1: Vendor shall be re-qualified only after the satisfactory facility audit report. 備注1：只有工廠審計報告合格后，供應商才可以重新獲得資質(zhì)；Note 2: In case of contract givers product, prior approval from Product License (PL) holder shall be obtained before audit for requalification. 備注2：如果是合同加工項目，對供應商進行資格再審查之前應先獲得產(chǎn)品證書所有者的批準。Critical issues shall be closed within 30 working days. In case of overseas vendor, the time could be extended to another 15 working days.關鍵性問題應該在30個工作日內(nèi)完成，若涉及到海外的供應商，可再延長15個工作日。6.7.1.3 Major主要的6.7.1.3.1 If audit compliance report of the vendor is not justifiable.如果供應商的審計報告顯示和現(xiàn)實不符合；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；6.7.1.3.3 Trend data reveals reoccurrence of Quality problems.(Reoccurrence Repetitive in three months)數(shù)據(jù)趨勢分析發(fā)現(xiàn)質(zhì)量問題反復發(fā)生（反復-3個月內(nèi)重復發(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.供應商提供的物料相關的文件與以前的格式不符；6.7.1.3.6 Vendor frequently fails to supply the material as per committed scheduled time,供應商經(jīng)常不能按時供貨；6.7.1.3.7 If vendor fails to meet the requirement after warning.警告后供應商仍不能達到相關要求；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.如果來自同一個供應商的一種物料發(fā)生了三種以上的常見問題（3個月內(nèi)重復發(fā)生）就應當被視為關鍵問題。6.7.1.3.9 Out of trend results 偏離趨勢的結果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.應當及時和各供應商溝通他們所存在的問題，根據(jù)他們的回復以及所采取的措施，決定是給予警告還是需要進行再審計Major issues shall be closed within 60 working days.主要問題應當在60個工作日內(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.除了上述問題，其余問題均被認為是次要的問題。6.7.2 During course of evaluation/reauditing, if any information provided by the 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.在再審計和評估的過程中，如果供應商提供的信息一旦被發(fā)現(xiàn)是不真實的、錯誤的、誤導性的或發(fā)生了沒有聲明的變更，在經(jīng)過調(diào)查確認后，可撤銷該供應商的資質(zhì)。6.7.3 If any vendor is disqualified the approved vendor list shall be updated immediately and the revised copy shall be circulated to the concerned department.任何供應商的資質(zhì)被撤消后，批準的供應商列表應及時更新，并將更新后的版本發(fā)放給各相關部門。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)量問題被退回，這種情況應當按照X-SOP-QA038 OOS管理規(guī)程進行處理。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 Materia