国外供应商审计GMPQuestionna.docx

1、国外供应商审计GMPQuestionnaCOMPANY 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

2、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

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?No.G

7、ENERALYESNOCOMMENTS14.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 p

8、oints 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 testin

9、g 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 proce

10、dure? 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 readi

11、ly available for each piece of equipment requiring calibration? No.GENERALYESNOCOMMENTS24.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 equ

12、ipment 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 adher

13、ed 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 equipme

14、nt 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 cl

15、eaning 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 equ

16、ipment (i.e. tanks, reactors, fluid bed dryers, hoses, connectors, ancillary equipment)? No.GENERALYESNOCOMMENTS34.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

17、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

18、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 in

19、spection 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 ident

20、ified and segregated from accepted materials? No.GENERALYESNOCOMMENTS46.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

21、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-cyclin

22、g (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 sp

23、ecify 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 s

24、tage 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?No.GENERALYESNOCOM

25、MENTS58.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

26、 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

27、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.D

28、o 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

29、identified and segregated? 72.Are there procedures and controls to prevent cross-contamination between lots and are these procedures documented? No.GENERALYESNOCOMMENTS73.Are materials properly labelled to preclude error in issuance? 74.Are there procedures for the control and issuance of material? 75.