Supplier Checklist for Audit（供应商审计检查清单英文版）.doc

CHECK LIST FACTORY _PRODUCT _DATE _AUDITOR _ORGANIZATION1.Organization chart of personnel Quality Unit Presentation Hard CopyCertification GMP, ISO, Safety, Environmental ,OthersCustomer Audit 2.Number of personnel employed in the factory Total production:_ QC:_ QA :_ laboratory :_ warehouse:_ maintenance service:_ other:_3.Turnover last 2 years2009:_2010:_% FIS products on the total turnover4.Capacity for the intermediate N# of Batch /day:Quantity per batch:Capacity /monthMax Q /Year: 5.General overview of manufacture:See 15, 16 page 3 Facilities square meters nequipments/ vol nprocesses/ type 6.Organization of the work: No.days/week _No. Hours/day_No. Shifts/day_Instruction for shift : 7.Management of responsibility Quality responsibility are in writing ?8.Document Management:See also page 10 QA System-Documentation list of SOP available ?FACILITIES TOURWAREHOUSE OF RAW MATERIALS AND OF INTERMEDIATES1.General Overview Well maintained, no broken or leaking containers ?Open or protected ? Presence of traps /Insects/ Birds ? Temp mapping ?2.Receiving Raw materials Solvents Packaging material Labels Returned goods3.Storage (general)-separation of raw material (chemical incompatibility; approved, rejected and quarantine material,) ?4.Lot numbering system: how raw materials and intermediate are identified?How is lot number assigned ?5.Quarantine Physical separation ?6.Does the labelling allow to distinguish between approved and non-approved material? Segregation ?7.Sampling (who, where)/ Approval ( who , how )8.Are RM received with CoA only ? rationale9.Labelling system for identification and status and re-test10.Dispensing / weighing Precaution not to dispense expired material11.Solvent tanks identification 12.Track unloading pipes- Sampling from track? Cleaning certification of track ?13.Purchasing process identified qualified sources ?14.Management of BSE/TES; GMO requestsPRODUCTION15.Facility General overviewWell maintained, no rusty equipmentOpen or protected ? Presence of traps /Insects/ Birds ? Space and separation , Open to out of doorsSeparated by solid floors/wallsHousekeeping to prevent cross-contamination16.Only pharma products/intermediates? Penicillins, steroids, alkaloids, cephalosporins, high potent drugs, pesticides ?17.Kind and dimension of apparatus in the plant: reactors, centrifuges, filter dryers, static dryers, etc.Reactors: number of glass lined reactors : _ capacity stainless steel reactors:_capacity Centrifuges Filter dryer Static dryers Blenders Distillation capacity 18.Identification of equipmentLog book (equipment status, cleaning, maintenance )19.Master Batch Records / Batch Records/ Instructions20.Description of a typical batch record Verify presence in Mfg dept, the filling status 21.Is manufacturing process validated?See point 9022.Is the plant dedicated to the FIS intermediate?23.If not, how is performed the cleaning of the apparatus?Written instructions? Records ?24.Is cleaning status checked before use? How?25.Thermoregulation system and range of working temperature for the reactors26.System of charging of solids and liquids (chute/hopper, boxes, piping, drums etc.)Piping is cleaned?27.System of unloading solids / separation / Cross-contamination prevention28.How lot number is assigned ?Does it consider multiple sites or reprocessed material ?29.IPC sampling devices- cleaning and storage 30.Training of personnel Take one name of operator 31.How many batches/week are produced of the FIS intermediate?32.Which is the standard yield of each batch?33.Is it foreseen the recovery of solvent, especially in the synthesis of FIS intermediate?34.If yes, how it is solvent recovery carried out?Testing ( see point 91) 35.Does IQ, OQ, PQ of equipment available ?36.Preventive maintenance37.Are the instruments (thermometers, pHmeters, manometers, etc.) periodically controlled/calibrated?38.Description of the net for distribution of nitrogen39.Distribution of water system and degree of purification. ( civil water , purified , demineralised) Verify if a Microbiological control is in place40.Is water used for cleaning ?Is water used in FIS products?41.Protective personal equipment and technical measures when handling hazardous substances42.How many accident occurred in the last year?43.Disposal of side product: is there an incinerator and or a biological plant?44.Any restriction from local authority for chemical manufacturing .45.Fire protection system, if presentIs the factory insured in case of fire?46.Pest control systemVerify presence of traps FINISHING FACILITIES47.Does the FIS intermediate undergo any finishing treatment before shipment (i.e. milling, micronization, sieving, etc.)?48.Is a blending step performed ?Is the blending process validated for homogeneity?How ? see point 91How are tails treated ?49.Cleaning (general SOP, status etc of blender , of area )Suites, delta P50.Lot number identification 51.Dressing52.Sampling 53.Packaging 54.Labelling systemMis-labelling preventionWAREHOUSEFINAL PRODUCT55.Sampling for final testing(who,where, how)SOP (Statistical sampling, sample quantity, tools)Cleaning of tools for sampling see point 71 56.Availability to provide sample in the first drum for customer ?57.Final releaseResponsibility ?Is production docs verified ? By Whom ? 58.Rejected materialsSegregated Area ?59.Preparation (only one product/ lot each time ?) 60.Packaging61.Labelling system 62.Are drums cleaned before leaving the finishing dept ?63.Label reconciliation64.Shipping Instruction FIS VENICE/Milan PO NUMBER: ITEM CODE: NO.: 1-MADE IN CHINA PRODUCT NAME: BATCH NUMBER: NET WEIGHT: GROSS WEIGHT: MANUFACTURING DATE: EXPIRY DATE: SUPPLIER:MANUFACTURER:ADDRESS: 65.Are distribution records maintained? Are granting traceability ?66.Type , Quantity per drum67.Single lot per pallet 68.Pallet dimension CP1 / CP2Max120x120x120 cm69.Any Pallet treatment ( fumigation ?) QUALITY CONTROL70.Testing of:Verify the standard system from the receiving of a sample , testing, release for a raw material and one lot of the FIS Product Raw materials ( written specs and MoA, skip test applied?) IPC Intermediates Final product71.Sampling ( SOP nResponsibility for sampling RM Intermediates Final Product72.Tools for sampling final product Are cleaned ? Are disposable ? Where are they kept ?73.Retain samples How long are kept ? Packaging ?74.Instrument listnumber of instruments present in the lab:HPLC _IR _GC _Scales_Spectrophotometer_Other 75.Instrumentation Are systems identified ? Any IQ/OQ/PQ Calibrated according to a plan / scheduling ? Verify labels of last verification Records / Equipment logbook ? Columns ?76.Balances / Scales Frequence of calibration Who Perform Calibration Standard weight / certified ? Minimum quantity defined ?77.Analytical method/specificationsAnalytical written instructions are available for the personnel ?Are there analytical specifications for raw material in process test final products Assay : n of Std Inj ?, n of samples ? Impurities ? SST78.Analytical method validationFor release For cleaning 79.Customer request Managing of customer Specification and MoA80.Storage and retrieval of data81.Log-book Are raw data recorded in notebook ? Are notebook well fill in ? ( sample number, lot number , product, method of testing , scale used, instrument used , columns, RS, standardized solutions Are data verified by a second person ?82.Reference standard: labelling, storage, characterization, handling83.Procedure for the release of final product before sending to FIS Who verify compliance with specs?84.How long is the analytical documentation maintained85.Retain sample86.OOS ( out of Specification) 87.Use of external labs/ outsourced testing / responsibility 88.Training of personnel 89.Water System / sampling Microbial data 90.Solvent recovery Testing 91.Stability data Re-test Stability Chambers QA SYSTEMS DOCUMENTATION CONTROL92.Document Management: list of SOP numbering system preparation/ issuence/validity change control Availability to the workersRemoval of obsolete docs93.Deviations ( SOP _) Reporting Investigation Documentation Corrective actions94.Review of lot traceability.Batch Record Review95.Change control( SOP : Process Analytical Site Evaluation of the impact to the validated process Notification to customer(Any important change should be communicated to/approved by FIS)96.Manufacturing procedures:Master batch recordFilling of batch