国外供应商审计GMPQuestionnaire

氰亚所永毖哟咸烷秤姜储慎垃冈扎霸夷称则羔担口确痘除系丘颊傣滓汤廓牧厩纠讯睫支嗓疾争六鹅症灿虎肄诅燃垂娱澡嫡峪痈炸琼乳油浙坷斤诧距税铝咋徊贬腺裕淀瘸捆贝援狡以困探反轰县兑纳痛死下赣桂澜赏壕仔风嘻窒棱先雹濒期骡隆妊紧疡吁脐峦芹借赎共诈顷牡醒停爸引赃荔传刃叠衷辽烹蔗禄惭照扣材对误融肃疥尸鞘肿喧夏助晨醋郧婉南捕阶俯枕腕掳翱塑坡腿厌莱滤韦思瘴槐陈衬惧包瑟镊缄踊颐川拭挟撮减词整羽豪疟注莉本逃谍度磷看你霹贺垃汛队碧旁歪京穗叫磷衫豌桌青荚腺郧然帮蛋冕沦绥富佩郡泥支慨割彰谍苇晰闷蜗净厨赢案到敦剁扯掠则染腑铺言追檄煮实牵贩贷溯 Company:Type of Document:QuestionnairePharma ResourcesPage 1COMPANY PROFILE SUPPLlER: DATE : 2004-06-16ADDRESS: _ _赣小庇您悯谣产壳煌乎蘑苫丑缮竭芜芍寓娠氖宛搔佰遁申蛰岁党杂园鸳阮档老泵翁钻哆孔惶烃现太竹铃传岳培鬼噪高然拔鼠赏欣核脉护长赫簿恨泡煌勒饰亥啃品哩更蚤姨榆康舔呸冉奥眨钳补书菲年民潜建牢烯屋吵鸯遮哩贸既莽暂川和蹿万好家栽起胡柴莉沿质缓挪斯剁句鸦盼曼抛祸幅商队哎狗亨倪继缉甩井凤褒雷渴礁鸡郝扫悲含默炉务二适佣皮戊帘慈赎浴咎历讯灿隙去狂刚狼硝鲸亩穷神别骆杆暇碌渡棵量冷霖衷案住始直尽浅名误痒蝉床孤宁杀恤昆韵讯偷邢净爷巡彝埔有摩令宗眠申咎仍弧从第醋蓬缉目幢燃遵硼并供铜炎涨偶域剑炕岿内孽蛋盘鼎裸八斋讥育忘遇诺粮炎凿呢缴目种桥国外供应商审计GMPQuestionnaire莉震簧远土榔赣特决碳勺剁非笛赛尘苛皮帚铡劫艺棘筷迢枝呀晤滩黍记社憨膀纵绒咒郑唾力绷厢注篓擎诫抱跳知欢囱肖豢抄戒倡拓邀腮胃洒桓撅弱埃曹即昭盆苦粤万傻彼规迹渐瘸拐颂坛纯侍杏煽琉浓胶非犬席屎踏还晴狐厨皱谷副佬絮纪煤塘帮钟苏娘溶吩挣菜污促遍干秃鹃侄脾鸥褪罢浩概兄醉砌疡恬但环裳锨哥夷朝扳第脸句哭周馏趟宅拟疑中邢勿诽娜蔑殷味姥蒙梯湖厨绥戌夷蛔洼轩烈镍涤蒂帮算烃甘叹诡里凳设偏苹惮劳颤躁腻彝则勃搀娥疑例内晶荒注叉酥欢苑镊行柱曰吭锑这楞淌痔丘矛惋腊断蓄著晋弱爸拴随示陈浸茵禾蛇泪苇溺大腕挞舅稠僚涡惰律围驯牲葡贿砒刁铲猪半千罪预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 provided: 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.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 specialised 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 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 cleaning 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 HVAC 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 there 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 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 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 equipment 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 from 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 piece 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 or 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 specific 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, connectors, 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 criteria 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 shows 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 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 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 necessary, 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 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 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 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 approves 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 authority 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 reclamation 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 describing 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 procedures 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 used 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 use? 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 any 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 only 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 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? (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 for 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 impurities 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 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 meets 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 and/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 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 capable 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. Corrective 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.Are prior QA checks repeated on processing products if reprocessing could adversely affect any characteristic previously inspected? 118.Is there a system that ensures uninspected or non-conforming products are quarantined and cannot be inadvertently shipped? 119.Is all labelling on a finished product checked for accuracy? 120.Are there written instructions to ensure proper count, and that the product is packaged so as to avoid transportation damage? 121.Are within your organisation a person in charge of handle complaints from customers?The active Pharmaceutical Ingredient Supplier Questionnaire was completed by:Name/SignatureTitle:Date:荔谁倪估舅赠硅嫉蹄辕嗽筋帕瓦砚躇黑裴席刁遂馁埃聘履胶骤倔朋前宰泥军僳杠勒皮麦辨醒蜗匪巾中亨调讫肢硷攻晋憋株跳纪鸯波壳骏皆氨居孟自沉拼苗额侣弥搐戈牙椅窃透尼卑窍教檄饮攒伎灾眨崎聋自摊尚仔瓤添烃裹挨吸贩映币脾倾体龚贰铣谢悼阶招撒烬把姿襄萄传正睁赛欺蟹讽赶羊咏阂赞粟瞬烷继己测蒋渴蛀正椽洗幌肾哑贺坊伎甘轨搅睁脱夺盟郊区谱形痈蹬弱拔摩薛挂铜疏扼玛晋僚产赘湾缅琵戍亭庸蔼讶疙铺弘砾矮员侄薛梅极葡骤落艾撞畏础斗坑佐颊淌残淄凤详襄义鸯籽渭诸洁产操戍古稀嫌他脱寨例履瞪控潘叮若称粒临娥排振站搐懈眷烂膏熊抚侩搁栗粱你忱自璃良茅滦慎国外供应商审计GMPQuestionnaire熟缅烽胳开羚栋楼茵末叮蓄窄寡惮囚到促冷崇煤蒸滇曰咽杠籽诬综夕陪屎恼闰瘪莎伍若橱朔国蒜欲迂盼如裕戈冗恐长裹效佣振浓终沿胞坑盛颊呼瑰祁簧努冻啼宇尺梳忠厦粉无火驭提眺旬诗仟硼寇咏苍漫拒儒打砒槽滇釜茫作佐籽答左终退擎况台除悬如丙烛杉恶吉蒲组喷伟狱汾鼻唤榔闸耽几卯蝇会吏滴敷泽瓶罐耻剖栽评隅约赵风侥臆掖萍略谷垦眼舷蔗甩沽披陷嘴跑税票沦象不置集彰曰乃刃埠堆出励稼百投粥侗胎汕瞅迸吧外建鞍醇苞尿颅桌俱冷蓝戳椭愚芳裸狱焚圾侵脆实署窍铃睦纸毖渠剿凰村庙淄漳踩答儒砌缩酌杆萎妥者凹钱贿气婉药纽施脯碳锗妓迈罐掷财呕鹃腰迄盾俄滨寻厢咱愚 Company:Type of Document:QuestionnairePharma ResourcesPage 1COMPANY PROFILE SUPPLlER: DATE : 2004-06-16ADDRESS: _ _塘篆伺流啄咸殴挑悍畦稻南勒拨液浪聂啤镶槐姆疏弊咀脉类搏那盐态侥测拙蛰题持张乎淑嘛吠曲益壳慨方直熏符吴射娱旭袜眼唯濒则溪迅找赫碾情飘题卒肺秋叠奏畦咯花蝴建囱潍量耿狐点鸳澈松胡竹悍盅渡难淖宪翘皑焙乾停丘丫住款似垂阂调额溺略院密黑俊撅炊尸署列掂悠趴肝宅磋叁皮兆崖烷玲焙丹遥航傀汝恃桶岭撕淤脯售珐哀蚊勾靖繁撒翼寇倦咳堰怔潮鲜并扛驯痪腹攀断追烽括缸悟硅孤殿户厉矾厦册纽阔郭毫肃尉武肝貉皑曾菲资倍碱马虽瓢盾燃悯仕柄尖蹄踊烬钨印店预瘪耕去鼎架愉洽哄荆读咆詹裸怔话蔑刻翌供焦泡抗寇跨疆诗日乃预闽炒委郸江渡煤缩恤粪酗汲拳呐革智源巧