国外供应商审计GMPQuestionnaire

1、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

2、: 11 / 11文档可自由编辑打印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

3、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 a

4、reas 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

5、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

6、.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.I

7、s 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 expos

8、ure.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 h

9、ave 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 calibratio

10、n 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 p

11、iece 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 cy

12、cle 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 o

13、r 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

14、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 li

15、mited to a specific amount that does not adversely affect the product's 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 d

16、ryers, 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 writ

17、ten 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

18、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

19、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 app

20、roved disposition for damaged products issued? 47.Are records adequate for traceability to supplier's 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 r

21、eprocessing 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 recycl

22、ed 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 tempe

23、rature 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 sam

24、ples 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 producti

25、on 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 Q

26、A/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 mater

27、ials 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 specificati

28、ons 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 betwe

29、en 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 effec

30、ts? 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 accur

31、acy 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 oper

32、ation 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

33、 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?

34、 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

35、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

36、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 pro your API?Do you know at which stage each impurity coul

37、d 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

38、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 validatio

39、ns 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? 1

40、04.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 cros

41、s-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 o