GMP驗(yàn)廠審核檢查表

1、Retail Factory Audit ReportNon-Regulated Basic GMPQT Report:Audit Dates: 審核日期Report Date:報(bào)告日期Audit Owner:Audit ActiFactory Name: 工廠名字Lead Auditor: 審核組長(zhǎng)Address: 地址Auditor(s): 審核員FailPass With ConditionsPass#Major CAPAs:All program requirements forcertificate met?(RCP Cert Committee only)#Minor CAPAs:

2、Noncompliant不符合Marginal警戒Compliant符合CAPA follow-up required?NOYESNOT RCPFactory Grade: 工廠等級(jí)Factory Score:得分0.00%YESNO Scope of audit:Products:Most recent audit date:What entity performed the audit?Audit result:Types of certifications maintained:FDA Registration Type and Number:Company Representative

3、 during audit:Production Area- Ft2:# production lines:Packaging Area- Ft2:# Packaging lines:Warehouse - Ft2:Total Plant Size- Ft2:COMPLETE SECTION BELOW FOR CAPA FOLLOW-UP ONLYQT Report:Audit Dates:Report Date:FailPass With ConditionsPass#Major CAPAs:#Minor CAPAsRe-Audit required?All program require

4、ments for certificate met? (RCP Cert Committee only)NO YESNOT RCPNoncompliantMarginalCompliantFactory Grade:Factory Score:0.00%YES NO #BASIC GMP REQUIREMENT / CRITERIA / REFERENCEGMP 要求/標(biāo)準(zhǔn)/參考Total PossibleScore最高可能得分Points Scored實(shí)際得分Yes/ No是/否Major or minor主要/輕微Facilities and Equipment廠房/設(shè)備FE1Is the

5、 facility clean (internal/external)?Throughout the course of the assessment, observation of cleanliness should be taken. Cleanliness should be defined as an environment that reduces and/or eliminates the potential for contamination.工廠是否干凈（評(píng)估的整個(gè)過(guò)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 there wri

6、tten procedures addressing the maintenance of thefacility?Preventive Maintenance policies and schedules should be documented. Records should be available for review and should contain information regarding daily pre-operation equipment inspection, daily monitoring of equipment function, daily housek

7、eeping activities, sanitation activities and any other necessary activities to maintain the safety and quality of product.有沒(méi)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(lái)保證產(chǎn)品的安全和質(zhì)量 200FE3Is there a list of approved chemicals for maintaining the sanitation of the facility?Chemical

8、s 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 observed in use without ap

9、proval or if any of the chemicals selected do not have MSDS provided, the answer is NO.是否有清潔用化學(xué)品清單。 這些用來(lái)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(méi)有在清單中的化學(xué)品，或則沒(méi)有MSDS， 答案就應(yīng)該是“No”100FE4Is storage of chemicals used in the facility adequate?Ensure that all chemicals are stored in a manner consistent with the ins

10、tructions per their MSDS sheets. Additionally, ensure that the method ofstorage is in such a manner to eliminate product contamination. Answer is NOif storage conflicts with either requirement 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”300FE5Is the facility in satisfactory structura

11、l condition?NoRodent Entry Points, No broken Glass or Windows, Ceiling does not indicate water damage or structural defects.廠房結(jié)構(gòu)是否令人滿意，沒(méi)有蟲害入侵點(diǎn)，沒(méi)有破碎的玻璃或窗戶。天花板沒(méi)有漏水的痕跡。300FE6Is waste material handled appropriately?Ensurethe dumpster areas are clean and well organized. External waste is not excessive.肥料

12、處理是否合適，垃圾桶附近干凈整潔。100FE7Is the design of the facility adequate to allow for smooth flow ofmaterials and reduce potential for contamination?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 environmental controls for the building?Ifthe product under assessment requires environmental controls,

13、ensure that the supplier has controlled and verified temperature at critical areas. If environmental control is inadequate, the answer is NO. If environmental control is not applicable to the production, the answer is 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(qǐng)確保供應(yīng)商有控制和確認(rèn)溫度。 300FE9Is the lighting adequate for t

14、he building?建筑內(nèi)部照明是否充足100FE10Is the pest control program adequate?Ensure that a contract exists that documents a regularly scheduled pest control service program. The contract package should include at a minimum: a) written documentation regarding the service performed and type of materials used; b)

15、 a current map indicating the locations of all rodent traps; c) copies of the licenses and certificates of insurance for the pest control company and current license for inspectors. Review a representative sample of inspection records from the last 12 months. Ensure that any pest problems noted have

16、 been addressed and had been addressed prior to the next inspection. Ensure the traps/devices are traceable either by numerical labeling, bar coding or other method. Ensure that the pest control inspector has initialed or provided some other documentation to support that all traps had been properlyi

17、nspected. Finally, to receive a YES for this question, no sign of rodent activitywas noted during the course of this assessment.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)容和所有材料 b)鼠籠的安放位置圖 c) 蟲害防治公司的營(yíng)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(hào)，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 clean and in good

18、working order?Clean, stocked with Antibacterial Soap and single use napkin/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 organized spare parts inventory kept on hand at the factory?Look for a room or area separate from production that contains spare parts for the production equip

19、ment. Does not need to be all spare parts, but at a minimum should be critical parts needed to keep the equipment running. Factory should have inventory list.備件倉(cāng)是否組織良好？備件倉(cāng)需同生產(chǎn)隔離。關(guān)鍵零件必須要備件并有清單控制100TOTAL SCORE FOR THIS SECTION2500Quality System品質(zhì)系統(tǒng)Organization and Personnel組織和人員QS1Is a Table of Organi

20、zation (ToO) available for review?Current?Approved? Controlled? Must be able to say YES to these subsequent requirements in order to score YES.組織架構(gòu)圖？ 最新，有批準(zhǔn)和受控200QS2Is quality assurance independent of manufacturing?Ensurethat the ToO describes separation of manufacturing authority and quality assura

21、nce authority.有沒(méi)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 supervisorypersonnel shown on the ToO?主管以上人員必須要簡(jiǎn)歷保存100QS4Does the quality department have adequate coverage during allshifts?Review last 30 days of shift schedules. For every production shift, there must be

22、documented QC coverage to score a YES. *Guidance:“Documented QC Coverage” may be demonstrated through a combination of both of the following practices: 1) Designation of “Quality Responsible” operator(s) during a 2nd or 3rd shift. This is acceptable so long as verification of training may be provide

23、d and conclusion drawn that designated “Quality Responsible” operators have the education, experience and knowledge to act in the role of QC. 2) The vendor must have procedure and records to ensure that QA reviews and releases all batches prior to shipment.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，

24、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(shí) 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。 300QS5Is there a written procedure for general GMP training?Thisshould be a procedure or other documents defining frequency of training, general scope of training, training provider and methodology for determining com

25、petency.GMP 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 individuals randomly selected?Randomly select an appropriate sample based on the size of operation to verify training records exist. If no record exists for sampled employees, score NO.隨機(jī)檢查培訓(xùn)記錄100QS7Do training records

26、contain names (trainer/trainee), dates andsubject matter?Also ensure the records demonstrate conformance with the 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 sufficient means for verifying trainee comprehension?Review the method of training verification. Ensure that it is appro

27、priate 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 materials available for review?Slides,handouts, other documentation to demonstrate training provided conforms 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 facili

28、ty sanitation,personal hygiene, and recordkeeping?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 employees practice sanitation and hygiene in themanufacturing operations?During the walk through of production, storage, etc. observe employees to ensure all sanitation and hygiene policies are implemented. If obser

29、vation determines policies are not being followed, must score NO.員工是否按照衛(wèi)生要求開展工作，在現(xiàn)場(chǎng)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 for individualsrandomly selected?Specifically verify any employee observed not following sanitation and hygienepolicies to determine if theyve been

30、 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(méi)有按照衛(wèi)生要求做事的員工200QS13Are OTJ training records complete and adequate?Contains names (trainer/trainee), dates and subject matter, specific reference 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

31、should cover all critical processes utilized for the controlled manufacture of product(s) included in the assessment scope to score YES.有沒(méi)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 a satisfactorymanner?Current? Approved? Controlled? Must be able to say YES to the

32、se subsequent requirements in order to score YES.SOP是否文件化，有編號(hào)和被批準(zhǔn)。最新，有審批和受控300QS16Is distribution of new and revised SOPs and retrieval of obsoleteSOPs adequate?有沒(méi)有SOP修改，分發(fā)控制程序200QS17Do documented INSPECTION procedures or instructions exist?Review inspection procedure documentation.檢查作業(yè)指導(dǎo)書，100QS18Ar

33、e SOPs reviewed periodically to ensure their applicability tocurrent practices?SOP定期審查100QS19Is there a documented change control procedure for planned andunplanned changes to production processes?有沒(méi)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 changes relating to manufacturing/packaging processesadequ

34、ately approved, where necessary?These changes should be approved by the responsible parties identified in the change control procedure indicated 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 production?生產(chǎn)登記本100QS22Is the use of logbooks detailed in

35、a written procedure?文件化的生產(chǎn)登記本使用說(shuō)明100QS23Are logbooks clear with respect to actions taken by individuals?生產(chǎn)登記本記錄清晰，可以看清楚沒(méi)有人的動(dòng)作記錄。100QS24Do logbooks exhibit good documentation practices with respect tochanges, legibility and sequence of events?No whiteout, scratch out marks, etc. Changes to these reco

36、rds should be made with a single cross-out and be initialed 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 ensure their adequacy?生產(chǎn)登記本記錄是否定期檢查100QS26Is there an adequate written program for the maintenance ofproduction records for each finished product manufactur

37、ed?是否有合適的文件化程序來(lái)維護(hù)每批產(chǎn)品的生產(chǎn)記錄300QS27Do batch production records contain adequate information withrespect to the packaging of finished products?Ensure packaging labels/information include adequate information to support that production records are accurate with respect to identification, quantity, weigh

38、t, material, etc.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 production records contain the required informationnecessary with respect to assuring the quality of finished products?Ensure production records contain identification of the type of material, amount of material, and verification of any criti

39、cal steps per the specification 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 documentation practices withrespect to changes, legibility and adequacy of entries?No whiteout, scratch out marks etc. Changes to these records should be made with a single cross-out and be ini

40、tialed and dated to score YES.批生產(chǎn)記錄改動(dòng)謹(jǐn)慎，清晰易讀。沒(méi)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 theseinvestigations?不良品原因調(diào)查是否有記錄200QS32Do investigations include a review of production and laboratoryevents

41、which may contribute 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 investigations are inconclusive and retesting is conducted, is theapproach to retesting based on sound rationale?如不良調(diào)查得出結(jié)論需要從新測(cè)試，那么測(cè)試方法是有合適300QS34Do all investigations conclude an actual or probable cause for thefailu

42、re?是否所有調(diào)查都給出實(shí)際或可能的原因200QS35Are investigations completed within a reasonable time frame?失效調(diào)查是否在合理的時(shí)間內(nèi)完成300QS36Does Quality Assurance adequately review the failureinvestigations?品質(zhì)部門是否合適地審查這些調(diào)查300Annual Product Review/Internal Audits/Corrective and Preventative Actions 年度產(chǎn)品審核/內(nèi)審/預(yù)防改善QS37Is there an ad

43、equate written procedure for conducting ProductReviews?This should contain frequency, methodology, responsible parties and record keeping requirements.是否有合適的程序來(lái)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 written procedure for conducting internalaudits?This should contain frequency, methodo

44、logy, responsible parties, recordkeeping requirements, authority, follow up or corrective action reference basedon internal 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)200QS39Are internal audits being conducted according to the procedure?內(nèi)審是否按程序進(jìn)行200QS40Is supporting documentation (schedules, au

45、dit reports, CAreports) for the audits available?Do these documents and records demonstrate conformance 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 form ofcorrective and/or preventative actions (CAPA) addressing root cause? 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)

46、生的原因200QS42Are CAPAs being completed and instituted within a reasonabletime frame? 改善行動(dòng)是否在合理的時(shí)間內(nèi)完成200QS43Does Quality Assurance follow-up and determine if the appropriateCAPA has been completed?This should bedocumented via the Corrective Action form or record utilized by the factory ORvia a subseque

47、nt internal audit of the deficient area.QA 是否跟進(jìn)并確保執(zhí)行合適的改善行動(dòng)300QS44Are corrective action plans developed and documented based onthe results of the weekly QC meetings?Is theredocumentation of corrective action plans in the QC meeting notes? Must 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 FO

48、R THIS SECTION8900Material System & Supplier Quality Management原材料和供應(yīng)商品質(zhì)管理Components Handling/Holding and Distribution部件/零件的處理與分發(fā)MS1Does the factory have a documented process to make sure thatincoming raw materials, components, and/or sub-assemblies conform to specifications, quality standards and U

49、S Safety requirements?Verify that there is a process documented to ensure all incoming raw materials, components and/or sub-assemblies conform to specifications and US Safety requirements. Paint tested for lead content, etc.工廠是否有文件化的程序來(lái)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(guó)安全要求， 美國(guó)安全標(biāo)準(zhǔn)包括油漆測(cè)試，鉛含量等300MS2Is ther

50、e an adequate procedure for the receipt, sampling andidentification of all raw materials?Ensure that inspection procedures extend to receipt and qualification of raw material. Ensure that records exist to support conformance to procedure. If no procedure or records exist, score NO.是否有文件化的檢查程序來(lái)接受，抽樣和

51、標(biāo)識(shí)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300MS3Are there adequate specifications for all components and rawmaterials received?Identification, type, grade, size, amount, weight, supplier, etc.原材料/零件的產(chǎn)品規(guī)格，包括識(shí)別，類型，等級(jí)，大小，數(shù)量，重量，供應(yīng)商等信息300MS4Are raw materials adequately quarantined until release by QA toprod

52、uction?Sample multiple raw materials and ensure a record exists to trace 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 components (raw materials, primary and secondarypackaging) being tested against appropriate and established specifications?所有零

53、件（原材料，主要和次要包裝材料）都按照和事的規(guī)格測(cè)試300MS6Where raw materials are not fully tested against specifications, is there a program for qualifying suppliers?如果原材料沒(méi)有合適的測(cè)試，有沒(méi)有供應(yīng)商認(rèn)可程序300MS7Where historical data is used to qualify suppliers, does historicaldata include information on all the characteristics listed in t

54、he specification?如果歷史數(shù)據(jù)用來(lái)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 testing?是否有歷史數(shù)據(jù)來(lái)支持減少測(cè)試的動(dòng)作200MS9Where audits are used to qualify suppliers, are audit reports adequate and available for review?Audit reports should contain name of supplier and auditor. T

55、hey should contain information regarding the process and/or departments covered. They should reference the methodology and/or requirements used to assess the supplier.如果用審查來(lái)認(rèn)可供應(yīng)商，那么是否有審查報(bào)告，這些報(bào)告包括供應(yīng)商名字，審核員，他們也應(yīng)該包括流程，部門。應(yīng)該有審查方法，要求等200MS10Does a program for periodic auditing of vendors (material andservice suppliers) exist?是否有對(duì)供應(yīng)商定期審查200MS11If Certificates of Analysis are accepted, verify that at least on onelot per year the item is fully tested?如果接受分析認(rèn)證。至少對(duì)原材料每年測(cè)試一批300MS12Are raw materials, in-process materials and finish