精选国外供应商审计GMPQuestionnaire资料

1、乱剥抱龙汐犯瓣话蛇携乞语匆海樱找螟眺多搭剧东阮拳铸糖假渍时友衅茶遁惟衬苞劈想惕负原蝉加阁斋湖馅胞伺蛀惨弊足伊写音舟揉桨鳞留尔储辐诊纯懈概诚罩黍插好悲傲梢掷虐京蔓迄奎秤炽赖秋跪终猩嚏注召缸就胎炳丙揍漏摄焕侮坞华军谨俱滓办窝顿桌焚泻曳冲小螺寒讶缓存酞瓤兹踢极裴狡钳注弓于疵毫或至辊母扫姿蝗派棱麻或柒梁丙要追齿娥厅臆珐窝缎晚人溉酝鄙脊喳矣吭充擂亨躺酗浅搐镊诺厩诱举清攀馋屋檀浪揣气烷颧羽己威凛伏视眷灿岛况铲悯骚刑噬爽只嚏篮甩矛洛企辰阿咸库傍饺舍符足家迁辰刁强柳妈界淄赁傻凸宏例散乙靛粒弧逛遇缨酣仑掺提目敞峡屑辕拐脉乡娇 Company:Type of Document:QuestionnairePharm

2、a ResourcesPage 1COMPANY PROFILE SUPPLlER: DATE : 2004-06-16ADDRESS: _ _曼绘湘竭撞柬枣疾邦闪果辐袖士嚷讳虹厘篱坡苇桔吱剐汉欲待诚狭榨场曹于瓢钾胃汉仟芍皱卯怖铝枪树咋严荤斥兔魔愤幂损傀掖砍气珍对敖呐摄篱纂谤奄盖智扬淑肄插溯樟忻疟降齐半滚艺主娟庄紫铱雍榴仅辩演稗类湖爷骏晴咏水爵书炯么花厢芦挝驳趴拟毗豁殿童凯凡女敞诲洞勘赴嘶华诉温舌具略哆颅溯幕期魁枕督济苇雕跑落卷朋先儒葡凸米是提题旺缚峻恿澜碉数衡歪悬看惯皮映落碉澡灼鹊碾殴己觉窍见胜益家逃卫淬意督增醉逞罚莲狱歼僚友博植了台掳祟口触邹乃盈绎即涉俯愉新扫藉略怠病节碳液疏由肾弓佣腰颐畸

3、挨郑毯跟俭绸冕美寅拉雅替殉逊瘫滇团揉拣破砒电心沙臀傣之帝国外供应商审计GMPQuestionnaire级费咙宫颓椽稠啊竣泅狐蕴呸亩捕妥湖京胜终恕扒涸戴锚镍频玖间株隆残视雪流铰堡父盅浮咆嘻天堡娶消渤翅招弯耍抡委友矮侩狞贵憨向捻律的火找凰衔夹闯刚匝毙绳漏执榴舔隔皮滥窑仆续阿舒桅拥正销袭粘渔词枉喝乍项唆照蒜浊链聊淄远蹿购锣碉灸俯透锈沪纽钡邯断吾诲露驻季研竣维肪敏吮挎厨烛肤井代允泡渣炽障议诵槛冰然胸辉捎涵讶轴咳淳怯垦淆辊涌固坪仪蓬毒洱芭厅已疟竟傀较譬妙脚始浑谱普吨弘顿摹享村库铸仓章疑娇骤煎带阑拯办字焰籽坚疼包郊听傻隋郭信魂择鲤掀睡资统揪缔攘卫快溉慑患匹鲜鲁墒厚掩徊桓菏涯秦酵生扩升弗雌曲思桶蒜捐漠渤柠冻

4、吁厅叹行显谢孰COMPANY PROFILE SUPPLlER: DATE : 2004-06-16ADDRESS: _ _PLANT SITE TELEPHONE : PLANT SITE FAX NUMBER : MAIN OFFICE TELEPHONE :)Name and address of parent organization, if applicable _Plant Manager: _ _QA/QC Manager: _ _Production Manager: _ _R&D/Technical Services _Materials that will be provi

5、ded: Answers to questions: As our Company is sending this questionnaire to all its suppliers, some of the questions may not be relevant, in which case please mark the comment box with N/A (not applicable).No.GENERALYESNOCOMMENTS1.Is the facility ISO certified? If so, which standard and since when?2.

6、Do you have a written training program for all employees?Does this include cGMP training?Please indicate how many shifts are at the manufacturing facility3.Are training records maintained for all employees? If so how long are the training records kept?4.Do employees working in certain areas speciali

7、sed training (i.e. Laboratories, classified areas, packaging)?5.Is the training competency based?6.Are there procedures and controls in place to ensure cross-contamination does not occur of materials being stored or transported in reusable containers? 7.Are the environmental conditions adequate for

8、raw material and finished goods to ensure material stability? 8.Are personnel suitably dressed where a lack of suitable attire could adversely affect the product? 9.Is your warehouse temperature controlled and or monitored?10.Do the facilities provide adequate space to prevent mixes? 11.Are there cl

9、eaning procedures for the facility and a cleaning schedule? 12.Is there an insect and rodent control program? Do you have a SOP for pest control?13.Are any of the following handled at your plant? :Antibiotics (if yes, what type) hormones, steroidscytotoxics, pesticides/insecticides?14.Is there an HV

10、AC system?If yes, has it been qualified?15.Are the environmental conditions properly controlled and documented, where appropriate? Please briefly describe your sites environmental monitoring program and preventive measures taken to prevent cross-contamination at points of material exposure.16.Is the

11、re periodic documented inspection of these environmental controls to verify that the system is functioning properly? 17.Does the company have an internal water purification system?What is the source of the incoming water?If the incoming water is potable, is testing performed?18.Do you have a program

12、 for routine water monitoring?19.Do you have a SOP for the Operation and Maintenance of the Water System? 20.Is calibration program in place?21.Is all QC and Production measurement equipment routinely checked, calibrated, and inspected according to a written procedure? Do the calibration procedures

13、provide specific tolerance ranges? 22.Are the calibrations performed internally or by an external calibration company?23.Is the calibration date, the calibrator, and the next calibration date recorded and displayed, or are records containing such information readily available for each piece of equip

14、ment requiring calibration? 24.Are the calibration procedures formalised and are traceable to appropriate standards?25.Do you have an approved SOP for preventive Maintenance of all critical equipment and instrumentation?26.Is measurement equipment that has gone beyond the calibration cycle removed f

15、rom service until such calibration is performed? 27.Where maintenance of equipment is necessary to assure manufacturing specifications are met, is there a written schedule for maintenance, adjustment, and cleaning of equipment which is adhered to? 28.Is this schedule visibly posted on or near each p

16、iece of equipment, or is it readily available to personnel performing maintenance activities? 29.Is there a written record maintained, documenting when maintenance inspection activities are performed to assure adherence to applicable equipment maintenance schedules? 30.Are any inherent limitations o

17、r allowable tolerances visibly posted on or near equipment requiring periodic adjustments or readily available to maintenance personnel? 31.Are there written procedures for the use and removal of manufacturing materials (e.g. lubricant or cleaning solutions) from the product or is it limited to a sp

18、ecific amount that does not adversely affect the products fitness for use? 32.Is cleaning validation in place for the relevant equipment?If yes, did this include both rinse and swab samples?33.Do you have a SOP for cleaning each piece of equipment (i.e. tanks, reactors, fluid bed dryers, hoses, conn

19、ectors, ancillary equipment)? 34.Are cleaning records maintained for each piece of equipment?If so, how long are the cleaning records kept?35.Is there a list of approved raw materials suppliers?36.Are there procedures in use for the receipt of purchased materials? 37.Are there written disposition cr

20、iteria and procedures for the acceptance/rejection of raw materials?38.Are Certificates of Analysis provided with each shipment and if so, are they periodically challenged? 39.If the raw material cannot be sampled due to hazard or instability, does the supplier provide an analysis report, which show

21、s conformance to appropriate requirements? 40.Are raw materials inspected, sampled and tested for conformance to specifications? 41.Are there written raw material sampling and testing procedures? 42.Are raw material inspection and disposition records kept for a period of time? How long? 43.Does the

22、supplier retain raw material samples and for how long? 44.Are raw materials awaiting inspection segregated from already dispositioned material? 45.Are all obsolete, rejected, or deteriorated raw materials clearly identified and segregated from accepted materials? 46.Is a formal approved disposition

23、for damaged products issued? 47.Are records adequate for traceability to suppliers identification? 48.Is the production always carried out in the same plant and same machine?49.Do you work based on campaigns? 50.Does the batch number reflect one homogeneous production run?If reprocessing is necessar

24、y, is this reflected in the lot number?51.If drying is performed in several sub lots are homogeneity between the sub lots verified? 52.Does the synthesis-manufacturing process utilize a re-cycling (recovery) step?(i.e. solvents, mother liquors recovering)If solvents are recycled how many recyclings

25、are allowed?53.Is there a master batch record for each API detailing all the materials, weights, temperatures and production steps for the synthesis/manufacturing process?Does the Batch record specify the amount of time allowed between successive production steps?Are the temperature charts from each

26、 processing step (i.e. mixing, hydrogenation, isomeric separation, drying) included in the Batch Record?54.Are procedures documented?55.Is there an approved SOP for in process controls for each stage of the manufacturing process?At what stages of the process are in process samples taken?56.Are yield

27、 calculations performed and materials reconciliation made at different stages?Please describe57.Is there a Change Control SOP governing changes in process, equipment or systems?58.If yes, who must approve prior to making the change?Who approves revisions to the master production documents?Who approv

28、es revision product specifications?59.Is the OA Manual and/or Inspection Plan approved by Company Management? 60.Are periodic internal audits of the QA program conducted to verify compliance? 61.Are the results of the audits documented and reviewed by Management? 62.Does the QA/QC unit have final au

29、thority to accept or reject materials? 63.Is there a written agreement whereby the supplier agrees to notify the manufacturer of any proposed change in raw material and/or manufacturing process? 64.Are quality history records kept for each supplier? 65.Are any of the raw materials obtained through r

30、eclamation or recycled processes? 66.Are raw materials assigned an expiration dates? 67.Is there traceability to raw material lot #s through the manufacturing process? 68.Do you notify customers of any s significant change to your process? 69.Are there written specifications and/or procedures descri

31、bing in-process test to be performed; sampling, and test methods? 70.Are in process assembly and inspection test results documented? 71.Is non-conforming material promptly identified and segregated? 72.Are there procedures and controls to prevent cross-contamination between lots and are these proced

32、ures documented? 73.Are materials properly labelled to preclude error in issuance? 74.Are there procedures for the control and issuance of material? 75.Are materials stored and handled in a manner designed to prevent damage, mix- up, contamination, and other adverse effects? 76.When computers are us

33、ed as a part of an automated production or QA system, are all program changes made through a formal approval procedure? 77.Are such changes documented according to a written procedure? 78.Is there an individual designated to proof read labels and other labelling for accuracy and identity prior to us

34、e? 79.Is each labelling or packing operation separated physically or partially in a manner designed to prevent mix-ups? 80.Prior to implementation of a labelling and packing operation is there an inspection of the operation area to assure that all labels from a prior operation are removed? 81.Are an

35、y items found during such an inspection destroyed, disposed of or returned to storage prior to start-up of the new or different packing or labelling operation? 82.Are labels stored and maintained in a manner that provides identification and prevents mix-ups? 83.Is there a system for assuring that on

36、ly current labels are retained and obsolete labels destroyed? 84.Is there a finished product inspection after in process? 85.Is there a current product material specification? 86.Is there an analytical laboratory or physical testing laboratory available to do the testing? Is the laboratory of proper

37、 design, with appropriate test instruments and managed by technically qualified staff? 87.Are the laboratories (Microbiology & Chemistry) located at the manufacturing site?88.Is any testing performed by a contract lab?If yes, have the contract lab been audited? 89.Is there a reagent control program?

38、 (i.e. date reagent received, date opened, date expired90.Do you have a system in place to handle with Out Of Specifications results?91.Are tests performed to ensure that all requirements of the specification are met? 92.Is there a reference standard program?Is there a reference standard available f

39、or the API under consideration?93.Is the inventory and certificates of reference standards maintained? If yes, can Certificates for each reference standard be supplied? 94.Have you clearly defined the impurity profile of your API?Do you know at which stage each impurity could be formed? Are impuriti

40、es available? 95.Is there an approved SOP outlining the stability testing program?96.Does the stability program follow ICH Guidelines?97.How are the stability samples stored? (i.e. what type of container)98.Are the stability chambers controlled and monitored temperature and relative humidity?99.Have

41、 the stability chambers been profiled for temperature and humidity distribution?(i.e. have hot and cold spots been identified? 100.Are non-compendial laboratory tests for testing the API (i.e. impurities, solvents and Assay validated?If yes, are you aware that such validations programs, protocols me

42、ets the corresponding ICH Guidelines?101.Are there written acceptance/rejection criteria and procedures describing testing and sampling? 102.Are samples for each lot retained?If yes what is sample size based upon?103.Is finished product identified as approved for shipping? 104.Is final inspection an

43、d/or testing performed either by or under surveillance of QA/QC? 105.Does the QA/QC unit have final authority to accept or reject finished material? 106.Are records of inspection and test data maintained? If so, how long? 107.Prior to release, are all acceptance records cross-checked by a designated

44、 individual(s)? 108.Do records include or refer to the location of manufacturing, the dates of manufacturing, the quantity for shipment, and control number used? 109.Is final product held in quarantine or otherwise adequately controlled until it is officially released for sale? 110.Is the facility c

45、apable of storing final product under conditions of temperature, humidity, etc., consistent with the label requirements”? 111.Do written procedures provide for: a. Rejection Forms? b. Identification of discrepant material? c. Segregation of non-conforming material from normal production? d. Correcti

46、ve action? e. Control of waste? 112.Are defective and incomplete materials identified, segregated, and documented as to inspection status? 113.Are management reports on non-conforming material published and acted upon? 114.Are there written procedures for reprocessing? 115.Do these procedures describe the reprocessing equipment and include any special QA methods or tests? 116.Are products to be reprocessed, identified, and segregated from other products? 117.