2014版-GMP驗(yàn)廠審核檢查表

1、Retail Factory Audit ReportNo n-Regulated BasicGMPQT Repo rt:Audit Dates:審核日期Report Date:報(bào)告日期Factory Name:工廠名字Lead Auditor:審核組長Address:地址Auditor(s):審核員FailPass WithCon diti onsPass#MajorCAPAs:All program requireme nts for certificate met? (rcp CertCommittee only)#MinorCAPAs:Non complia nt不符合Margi na

2、l警戒Complia nt符合CAPA follow-up required?NOYESnot rcpFactory Grade:工廠等級Factory Score:得分0.00%YES?NO ?Products:Scope of audit:Audit result:Most recent audit date:What entity performed the audit?FDA Registration Type and Number:Types of certifications maintained:Company Representative during audit:Packag

3、ingProduction Area- Ft2 :# production lines:# Packaging lines: Area- Ft 2 :Warehouse - Ft2 :Total Plant Size- Ft2 :COMPLETE SECTION BELOW FOR CAPA FOLLOW-UP ONLYFactory Score:0.00%YES? NOQT Report:Audit Dates:I Report Date:FailPass With Co nditio nsPass#Major CAPAs:All program requirements for certi

4、ficateNon complia ntMargi nalComplia nt#Minor CAPAsmet? (RCP Cert Committee only)Factory Grade:Re-Audit required?NO YES not rcp#BASIC GMP REQUIREMENT / CRITERIA / REFERENCEGMP要求/標(biāo)準(zhǔn)慘考TotalPossibleScore最高可能得分Poi ntsScored實(shí)際得分Yes/ No是/否Major orminor主要/輕微Facilities and Equipment 廠房/設(shè)備FE1Is the facility

5、clea n (in ter nal/exter nal)?Throughout the course of the assessme nt, observati on of clea nli ness should be take n. Clea nli ness should be defined as an environment that reduces and/or eliminates the potential for con tam in atio n.工廠是否干凈(評估的整個(gè)過程都要觀察工廠清潔情況，工廠應(yīng)該有定義清潔的環(huán)境要素并持續(xù)改善清潔狀況)200FE2Are ther

6、e writte n procedures address ing the maintenance ofthe facility? Preve ntive Maintenance policies and schedules should be docume nted. Records should be available for review and should contain in formatio n regardi ng daily pre-operati on equipme nt in specti on, daily mon itori ng of equipme nt fu

7、n cti on, daily housekeep ing activities, san itati on activities and any other necessary activities to maintain the safety and quality of product.有沒有書面的廠房/設(shè)施維護(hù)程序？預(yù)防性維護(hù)的政策和程序。每日開機(jī)檢查記錄，每日設(shè)備功能檢查記錄，每日打掃衛(wèi)生記錄，以及其他所需的工 作來保證產(chǎn)品的安全和質(zhì)量200FE3Is there a list of approved chemicals for maintaining the san itati o

8、n of the facility? Chemicals used for any of the above activities should be defined within the approved procedures and policies. Material Safety Data Sheets should be maintained for all chemicals. An appropriate sample of chemicals should be selected and MSDS requested for each. If any chemicals are

9、 observed in use without approval or if any of the chemicals selected do not have MSDS provided, the an swer is NO.是否有清潔用化學(xué)品清單。這些用來清潔的化學(xué)品應(yīng)該有合適的批準(zhǔn)程序批準(zhǔn)， 有MSDS數(shù)據(jù)。如果發(fā)現(xiàn)任何沒有在清單中的化學(xué)品，或則沒有 MSDS ,答案 就應(yīng)該是“ No ”100FE4Is storage of chemicals used in the facility adequate?En sure that allchemicals are stored in

10、a manner con siste nt with the in structi ons per their MSDS sheets. Additi on ally, en sure that the method ofstorage is in such a manner to elim in ate product con tam in ati on. An swer is NOif storage con flicts with either requireme nt above.存儲(chǔ)化學(xué)品的設(shè)施是否合適/充足？確保所有化學(xué)品都按照其MSDS要求合適 存儲(chǔ)，避免污染。否則答案為“ NO

11、 ”300FE5Is the facility in satisfactory structural con diti on?NoRode nt EntryPoin ts, No broke n Glass or Win dows, Ceili ng does not in dicate water damage or structural defects.300廠房結(jié)構(gòu)是否令人滿意，沒有蟲害入侵點(diǎn)，沒有破碎的玻璃或窗戶。天花板沒有 漏水的痕跡。FE6Is waste material han died appropriately?En sure the dumpster areas arec

12、lean and well organized. External waste is not excessive.肥料處理是否合適，垃圾桶附近干凈整潔。100FE7Is the desig n of the facility adequate to allow for smooth flowof materials and reduce pote ntial for con tam in ati on?工廠平面結(jié)構(gòu)設(shè)計(jì)是否合理，可以是物料流轉(zhuǎn)順暢，避免潛在的污染風(fēng)險(xiǎn)200FE8Are there adequate environmen tal con trols for the buildi

13、ng?If theproduct un der assessme nt requires environmen tal con trols, en sure that the supplier has con trolled and verified temperature at critical areas. If environmen tal con trol is in adequate, the an swer is NO. If en viro nmen tal con trol is not applicable to the producti on, the an swer is

14、 N/A.建筑物是否有合適的環(huán)境控制，如果產(chǎn)品有環(huán)境控制需求，請確保供應(yīng)商有控制 和確認(rèn)溫度。300FE9Is the light ing adequate for the buildi ng?建筑內(nèi)部照明是否充足100FE10Is the pest con trol program adequate?En sure that a con tract exists thatdocume nts a regularly scheduled pest con trol service program. The con tract package should in clude at a mini

15、mum: a) writte n docume ntati on regard ing the service performed and type of materials used; b) a current map indicating the locati ons of all rode nt traps; c) copies of the lice nses and certificates of in sura nee for the pest con trol compa ny and curre nt lice nse for in spectors.Review a repr

16、ese ntative sample of in specti on records from the last 12 mon ths.En sure that any pest problems no ted have bee n addressed and had bee n addressed prior to the next in specti on. En sure the traps/devices are traceable either by n umerical labeli ng, bar codi ng or other method. En sure that the

17、 pest con trol in spector has in itialed or provided some other docume ntati on to support that all traps had bee n properly in spected. Fin ally, to receive a YES for this questi on, no sig n of rode nt activity was no ted duri ng the course of this assessme nt.蟲害控制程序是否合適？確保有外發(fā)的定期蟲害控制合約，合約至少包括a)服務(wù)內(nèi)

18、容和所有材料b)鼠籠的安放位置圖c)蟲害防治公司的營業(yè)執(zhí)照，檢查 12個(gè)月的蟲害控制記錄，鼠籠等設(shè)備有編號，可以追溯。鼠籠等設(shè)備合適安裝 并定期檢查證據(jù)300FE11Are the washrooms and toilets clea n and in good work ingorder? Clea n, stocked with An tibacterial Soap and sin gle use n apk in /towel, running hot water.水房和廁所是否良好？干凈，有防菌肥皂和一次性紙巾，熱水300FE12Is an orga ni zed spare par

19、ts inven tory kept on hand at thefactory? Look for a room or area separate from producti on that contains spare parts for the producti on equipme nt. Does not n eed to be all spare parts,1001but at a mini mum should be critical parts n eeded to keep the equipme ntrunning. Factory should have inven t

20、ory list.備件倉是否組織良好？備件倉需同生產(chǎn)隔離。關(guān)鍵零件必須要備件并有清單控制TOTAL SCORE FOR THIS SECTION2500Quality System品質(zhì)系統(tǒng)Orga ni zati on and Pers onnel組織和人員QS1Is a Table of Orga ni zati on (ToO) available forreview? Curre nt? Approved? Con trolled? Must be able to say YES to these subseque nt requireme nts in order to score Y

21、ES.組織架構(gòu)圖？最新，有批準(zhǔn)和受控200QS2Is quality assura nee in depe ndent of manu facturi ng?En sure that theToO describes separati on of manu facturi ng authority and quality assura neeauthority.有沒有獨(dú)立于生產(chǎn)的品質(zhì)保證部門。組織架構(gòu)同應(yīng)該有體現(xiàn)200QS3Are up to date biographies (CVs) available for supervisory pers onnel show n on the To

22、O?主管以上人員必須要簡歷保存100QS4Does the quality department have adequate coverage duringall shifts? Review last 30 days of shift schedules. For every producti on shift,there must be docume nted QC coverage to score a YES.*Guida nee:“ Docume nted QC Coverage ” may be dem on strated through acomb in ati on of b

23、o th of the follow ing practices: 1) Desig nati on of“ QuResponsible ” operator(s) during a 2nd or 3rd shift. This is acceptable so longas verification of training may be provided and conclusion drawn thatdesignated“ Quality Responsible” operators halve education, experieneeand kno wledge to act in

24、the role of QC. 2) The ven dor must have procedureand records to en sure that QA reviews and releases all batches prior toshipment.品質(zhì)部門是否有足夠的人員去覆蓋所有的生產(chǎn)班次？檢查最近30天 的生產(chǎn)安排，每個(gè)生產(chǎn)班，都必須有品質(zhì)文件，“品質(zhì)文件”是指：1)每班有 指定合格的品質(zhì)負(fù)責(zé)人，且品質(zhì)負(fù)責(zé)人有合適的培訓(xùn)，經(jīng)驗(yàn)和知識2)供應(yīng)商必須有程序和記錄確保出貨前qa檢查每批貨物。ality300QS5Is there a writte n procedure for g

25、en eral GMP training?This should be aprocedure or other docume nts defi ning freque ncy of training, gen eral scope of tra ining, tra ining provider and methodology for determ ining compete ncyGMP培訓(xùn)程序？程序要定義培訓(xùn)頻率，培訓(xùn)范圍，講師和培訓(xùn)方法100QS6Are training records available for in dividuals ran domlyselected? Ran

26、domly select an appropriate sample based on the size ofoperation to verify training records exist. If no record exists for sampled100employees, score NO.隨機(jī)檢查培訓(xùn)記錄QS7Do training records contain n ames (tra in er/tra in ee), datesand subject matter?Also en sure the records dem on strate con forma nee w

27、iththe procedure to score YES.培訓(xùn)記錄是否報(bào)考名字(講師和學(xué)員)，日期和培訓(xùn)主題。200QS8Is there a sufficie nt means for verify ing traineecomprehension?Review the method of training verification. Ensure that it isappropriate to the extent of responsibility for the product.是否有合適培訓(xùn)效果確認(rèn)方法200QS9Are satisfactory training materia

28、ls available forreview? Slides, han douts, other docume ntati on to dem on strate trai ning provided con forms to procedure.是否有合適的培訓(xùn)材料，幻燈片，印刷材料100QS10Do GMP training materials adequately address facility san itati on, pers onal hygie ne, and recordkeep ing? 培訓(xùn)材料是否有涵蓋廠房清潔衛(wèi)生，個(gè)人衛(wèi)生和記錄保存200QS11Do employe

29、es practice sanitation and hygiene in themanufacturing operati ons? Duri ng the walk through of producti on, storage, etc. observe employees to en sure all san itati on and hygie ne policies are impleme nted. If observati on determ ines policies are not being followed, must score NO. 員工是否按照衛(wèi)生要求開展工作，

30、在現(xiàn)場走訪時(shí)觀察員工和實(shí)施的人身狀況300QS12Are on the job (OTJ) training records available forin dividuals ran domly selected?Specifically verify any employeeobserved not following sanitation and hygiene policies to determine if theyve bee n provided the training.隨機(jī)檢查員工在職培訓(xùn)記錄，特別檢查那個(gè)沒有按照衛(wèi)生要求做事的員工200QS13Are OTJ trainin

31、g records complete and adequate?Contains n ames(trainer/trainee), dates and subject matter, specific referenee to machine, process, or activity.崗位培訓(xùn)記錄是否詳實(shí)，包括姓名(講師和學(xué)員)，日期，主題，參考材料和相 關(guān)活動(dòng)200QS14Are SOPs available for review?SOPs should cover all critical processesutilized for the con trolled manu factur

32、e of product(s) in cluded in the assessme nt scope to score YES.有沒有SOP (標(biāo)準(zhǔn)作業(yè)程序)，SOP應(yīng)該涵蓋所有關(guān)鍵受控工序300QS15Are SOPs written, identified and approved in asatisfactory manner?Curre nt? Approved? Con trolled? Must be able to sayYES to these subseque nt requireme nts in order to score YES.SOP是否文件化，有編號和被批準(zhǔn)。最新

33、，有審批和受控300QS16Is distribution of new and revised SOPs and retrieval of200obsolete SOPs adequate?有沒有SOP修改，分發(fā)控制程序QS17Do docume nted INSPECTION procedures or in structio nsexist? Review in specti on procedure docume ntati on.檢查作業(yè)指導(dǎo)書，100QS18Are SOPs reviewed periodically to en sure their applicability t

34、o curre nt practices?SOP定期審查100QS19Is there a docume nted cha nge con trol procedure for pla nnedand un pla nned cha nges to producti on processes?有沒有文件化的變更控制程序，包括計(jì)劃內(nèi)的生產(chǎn)工序變更和非計(jì)劃的變 更300QS20Are cha nges relati ng to manu facturi ng/packagi ngprocesses adequately approved, where n ecessary?These cha ng

35、esshould be approved by the responsible parties identified in the change control procedure in dicated above to score YES.有關(guān)生產(chǎn)/包裝的變更是否有合適的批準(zhǔn)程序。300QS21Are logbooks available for review with respect to producti on?生產(chǎn)登記本100QS22Is the use of logbooks detailed in a writte n procedure?文件化的生產(chǎn)登記本使用說明100QS23A

36、re logbooks clear with respect to acti ons take n by in dividuals?生產(chǎn)登記本記錄清晰，可以看清楚沒有人的動(dòng)作記錄。100QS24Do logbooks exhibit good docume ntati on practices with respectto cha nges, legibility and seque nce of even ts?No whiteout, scratch outmarks, etc. Chan ges to these records should be made with a sin gle

37、 cross-out and be in itialed and dated to score YES.生產(chǎn)登記本是否更改謹(jǐn)慎，清晰易讀100QS25Are logbooks periodically reviewed to en sure their adequacy?生產(chǎn)登記本記錄是否定期檢查100QS26Is there an adequate writte n program for the maintenance of producti on records for each fini shed product manu factured?是否有合適的文件化程序來維護(hù)每批產(chǎn)品的生產(chǎn)記

38、錄300QS27Do batch producti on records contain adequate in formati onwith respect to the packagi ng of fini shed products?En sure packag inglabels/information include adequate information to support that production records are accurate with respect to ide ntificati on, qua ntity, weight, material, etc

39、.批生產(chǎn)記錄是否包括關(guān)于成品包裝的合適信息，標(biāo)簽信息300QS28Do batch producti on records contain the requiredinformation necessary with respect to assuring the quality offinished products?Ensure production records contain identification of thetype of material, amount of material, and verification of any critical steps per the

40、 specificati on to score YES.批生產(chǎn)記錄是否包含原材類型，數(shù)量個(gè)關(guān)鍵步驟確認(rèn)規(guī)范300QS29Do batch records exhibit good docume ntati on practiceswith respect to cha nges, legibility and adequacy of en tries?Nowhiteout, scratch out marks etc. Chan ges to these records should be madewith a sin gle cross-out and be in itialed and

41、dated to score YES.批生產(chǎn)記錄改動(dòng)謹(jǐn)慎，清晰易讀。沒有涂鴉，修改有備注時(shí)間和簽名100QS30Are batch records reviewed by QA prior to archival?批記錄在存檔前必須有QA檢查確認(rèn)300QS31Are adequate records maintained with respect to these in vestigati ons?不良品原因調(diào)查是否有記錄200QS32Do in vestigati ons in clude a review of producti on andlaboratory events which

42、may con tribute to or be the cause of the failure?調(diào)查是否包括檢查生產(chǎn)記錄，實(shí)驗(yàn)室記錄200QS33If in vestigati ons are incon clusive and retest ing is con ducted, is the approach to retesti ng based on sound rati on ale?如不良調(diào)查得出結(jié)論需要從新測試，那么測試方法是有合適300QS34Do all in vestigati ons con clude an actual or probable cause for t

43、hefailure?是否所有調(diào)查都給出實(shí)際或可能的原因200QS35Are in vestigati ons completed withi n a reas on able time frame?失效調(diào)查是否在合理的時(shí)間內(nèi)完成300QS36Does Quality Assura nce adequately review the failure in vestigati ons?品質(zhì)部門是否合適地審查這些調(diào)查300Annual Product Review/I nternal Audits/Corrective and Preven tativeActions年度產(chǎn)品審核/內(nèi)審/預(yù)防改善QS

44、37Is there an adequate writte n procedure for con duct ingProduct Reviews?This should con tain freque ncy, methodology,resp on sible parties and record keep ing requireme nts.是否有合適的程序來主導(dǎo)產(chǎn)品審查，包括審核頻率，方法，責(zé)任人和記錄保持100QS38Is there an adequate writte n procedure for con duct ingin ter nal audits?This shoul

45、d contain freque ncy, methodology, respon sibleparties, record keep ing requireme nts, authority, follow up or corrective acti on200refere nee based on in ter nal audit results.是否有內(nèi)審程序，包括頻率，方法，責(zé)任方，記錄，擁有者和改善行動(dòng)跟進(jìn)QS39Are internal audits bei ng eon ducted accord ing to the procedure? 內(nèi)審是否按程序進(jìn)行200QS40Is

46、supporting documentation (schedules, audit reports, CAreports)for the audits available?Do these docume nts and records dem on strateconformance to the procedure?內(nèi)審計(jì)劃，內(nèi)審報(bào)告，內(nèi)審改善報(bào)告，200QS41Are responses to the audit findings/observations in the formof corrective an d/or preve ntative acti ons (CAPA) add

47、ress ing rootcause?內(nèi)審負(fù)責(zé)撰寫改善行動(dòng)的人是否有也謝清楚了不良發(fā)生的原因200QS42Are CAPAs being completed and in stituted withi n a reas on able timeframe?改善行動(dòng)是否在合理的時(shí)間內(nèi)完成200QS43Does Quality Assura nce follow-up and determ ine if theappropriate CAPA has bee n completed?This should be docume nted viathe Corrective Acti on form

48、or record utilized by the factory OR via asubseque nt in ter nal audit of the deficie nt area.QA是否跟進(jìn)并確保執(zhí)行合適的改善行動(dòng)300QS44Are corrective action pla ns developed and docume nted basedon the results of the weekly QC meeti ngs?Is there docume ntati on ofcorrective action plans in the QC meeting notes? Mus

49、t see to score a YES.是否在每周的品質(zhì)會(huì)議中開發(fā)改善行動(dòng)記錄。200TOTAL SCORE FOR THIS SECTION8900Material System & Supplier Quality Management 原材料和供應(yīng)商品質(zhì)管理Comp onents Han dli ng/Hold ing and Distributio n部件/零件的處理與分發(fā):MS1Does the factory have a docume nted process to make sure that in com ing raw materials, comp onen ts, a

50、n d/or sub-assemblies conform to specificati ons, quality sta ndards and US Safety requireme nts? Verify that there is a process docume nted to en sure all in com ing raw materials, comp onents an d/or sub-assemblies conform to specificati ons and US Safety requireme nts. Paint tested for lead conte

51、nt, etc. 工廠是否有文件化的程序來確保原材料，零件，外發(fā)加工品符合產(chǎn)品規(guī)范，品質(zhì) 標(biāo)準(zhǔn)和美國安全要求，美國安全標(biāo)準(zhǔn)包括油漆測試，鉛含量等300MS2Is there an adequate procedure for the receipt, sampli ngand ide ntificati on of all raw materials?En sure that in specti onprocedures extend to receipt and qualification of raw material. Ensure that records exist to suppo

52、rt confo rma nce to procedure. If no procedure or records exist, score NO.300是否有文件化的檢查程序來接受，抽樣和標(biāo)識所有原材料。確保檢查程序包括接 受和認(rèn)證原材料。確保所有檢查記錄按照程序進(jìn)行MS3Are there adequate specifications for all components andrawmaterials received?Ide ntificati on, type, grade, size, amo unt, weight,supplier, etc.原材料/零件的產(chǎn)品規(guī)格，包括識別，

53、類型，等級，大小，數(shù)量，重量，供應(yīng)商 等信息300MS4Are raw materials adequately quara nti ned un til release by QAto production?Sample multiple raw materials and ensure a record exists totrace from receipt to qualification. If no trail exists, score NO.是否所有原材料在分發(fā)給生產(chǎn)部之前都有QA檢查記錄，抽樣300MS5Are all comp onents (raw materials, p

54、rimary andsec on dary packagi ng) being tested aga inst appropriate and established specificati ons?所有零件(原材料，主要和次要包裝材料)都按照和事的規(guī)格測試300MS6Where raw materials are not fully tested aga inst specificati on s, is there a program for qualify ing suppliers?如果原材料沒有合適的測試，有沒有供應(yīng)商認(rèn)可程序300MS7Where historical data is used to qualify suppliers, doeshistorical data include information on all the characteristics listed inthe specificati on?如果歷史數(shù)據(jù)用來認(rèn)證供應(yīng)商，這些歷史數(shù)據(jù)是否包括材料規(guī)格書中列出的所有特征。200MS8Does the historical data support the use of reduced testi ng?是否有歷史數(shù)據(jù)來支持減少測試的動(dòng)作200MS9Where audits are used to qualify