ࡱ>  ` bjbjss8` ` ` ` ` ` ` t 8ܻd@ t 0h#:RRR-~D$3555555$&hY` --Y` ` RR666` R` R36366X` ` ^R\ @k=:~4w[Hg600[((^^J(` #_d'65 ASYYd0t $ $ $t t t t ` ` ` ` ` `   E. Extended Quality QuestionnaireMaterial Brand NameChemical Name (if applicable)Product Code FORMTEXT       FORMTEXT       FORMTEXT      General Information1.1.Are customer audits and/or inspections by agencies permitted?Yes  FORMCHECKBOX No  FORMCHECKBOX 1.2Is the decision to release or reject a product for sale independent from production?Yes  FORMCHECKBOX No  FORMCHECKBOX 1.3.Who is signing the Certificate of Analysis (Analytical Report)? FORMTEXT      1.4Who is responsible for the final product release? FORMTEXT      1.5.Who is responsible for contacts with us concerning quality matters? FORMTEXT      1.6What kind of product do you manufactureBulk raw materials?Yes  FORMCHECKBOX No  FORMCHECKBOX Bulk raw materials for pharmaceuticals?Yes  FORMCHECKBOX No  FORMCHECKBOX Active pharmaceutical ingredients?Yes  FORMCHECKBOX No  FORMCHECKBOX Technical products?Yes  FORMCHECKBOX No  FORMCHECKBOX Packaging material?Yes  FORMCHECKBOX No  FORMCHECKBOX Others?Yes  FORMCHECKBOX No  FORMCHECKBOX  Please, specify:  FORMTEXT      1.7Please, give a brief flow diagram of the process, including information about where in-process controls are performed. Special attention must be given to the last step in the process e.g. reagents, precipitation agent and solventsRef: FORMTEXT       Personnel, Training and Education2.1Do you have written job descriptions for all personnel?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.2Do you have procedures that document how you perform training?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.3Do you maintain records of the training?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.4Is your personnel aware that the products supplied are used for the manufacturing of active pharmaceutical ingredients?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5Does the Training Program in place have the following elements:2.5.1Formal Introduction to Regulatory Guidance (GMP, ISO, etc.)Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.2New Hire ProgramYes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.3Specific training e.g. clean room or handling toxic, infectious or sensitising materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.4Periodic assessment of practical effectiveness?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.5Periodic refresher training programs for established employees?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.6At the start of new product manufacturing?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.7When new methods are used?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.5.8Quality techniques for production people?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.6Does your training program emphasise:2.6.1Product integrity?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.6.2Hygiene?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.6.3Cleanliness?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 2.6.4Other?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  Please specify:  FORMTEXT       Facility and Utilities3.1Were the premises designed or adapted for the present use? FORMCHECKBOX  designed FORMCHECKBOX  adapted3.2Are there separate areas for:3.2.1Handling of starting materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.2.2Manufacturing?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.2.3Quarantined finished products or are other control systems in place?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.2.4Approved finished products?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.2.5Packaging and dispatch?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.2.6Rest and eating?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.3Does the present design prevent:3.3.1Chemical contamination?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.3.2Physical contamination?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.3.3Microbial contamination?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.4Are your working-rooms:3.4.1Of proper size for the intended functions?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.4.2Satisfactorily lighted, air-conditioned?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.4.3Clean and cleaned-up?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.4.4Designed to avoid (cross-) contamination?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.4.5Supplied with security and fire protection measurements?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.5Do you have written Good House Keeping Procedures?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.5.1If yes, do you maintain follow- up records of these procedures?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.6Do your manufacturing locations follow Good Manufacturing Practices?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.7Are your sites inspected by the FDA or national (health) authorities?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.8Are plant supply pipelines identified and labelled?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.9Do you monitor the quality of the water used to prepare standards and reagents?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 3.10Do you monitor the quality of the water used during the manufacturing process?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  Machines and Equipment4.1Is the production line multi purpose or single purpose? FORMCHECKBOX  multi FORMCHECKBOX  single4.1.1lf multi, what other products do you manufacture there? FORMTEXT      4.2Is there a maintenance and preventative maintenance program for all pieces of equipment?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.3Do you have written maintenance and calibration procedures for critical equipment?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.4Can all critical apparatus and devices easily be recognised as such, e.g. by calibration stickers?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.5Are these calibrations traceable back to national standards?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.6Do you retain records of calibration as evidence of control? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.7Is there a cleaning plan/procedure for production machines, equipment?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.8Have the cleaning and sterilisation processes been validated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.9Is any manufacturing equipment software controlled?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.10Do you have a documented procedure for the validation of all test and measuring equipment used to demonstrate the conformance of product to the specified requirements?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.11Do you retain records of validation as evidence of control?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.11.1If yes, Is the software validated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Are modifications of software (or its use) implemented by manufacturing personnel?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Is there a procedure concerning change of software and its copying?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Is the security of software controlled?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.12Do you contract out any of the following services4.12.1Instrument Calibration?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 4.12.2Preventative / Breakdown Maintenance?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX   Production and Process Control5.1Is your manufacturing process validated?Yes  FORMCHECKBOX No  FORMCHECKBOX 5.1.1If not, do you have plans to do so?Yes  FORMCHECKBOX No  FORMCHECKBOX 5.1.1.1If you do: what is your target date for completion? FORMTEXT      5.2How do you define your lot/batch? FORMTEXT      5.3How and by whom are lot/batch numbers assigned? FORMTEXT      5.4What is your normal lot/batch size? FORMTEXT      5.5Does each lot/batch have an identification number?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.6If, for capacity reasons, you combine material coming from more than one particular piece or part of process equipment into one lot/batch:5.6.1Is the lot/batch being homogenised prior to packaging?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.6.2Is the homogenisation operation validated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.7Do you manufacture according to a written procedure for each product supplied to the market?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.8Are these procedures approved by QA?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.9Do you have a batch record for each batch/lot manufactured?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.9.1If yes, do the batch records detail the following:Description, Lot Number & Quantities of Material used?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Processing Conditions (Temperature, Times etc)?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX The identification of the Person who performed the particular step?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Results of any In-process tests?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX All deviations from standard conditions?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX All cleaning operations carried out before & after batch manufacture?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.9.2If yes, for how long do you keep the batch records?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.9.3If yes, are these records formally checked and approved by QA?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.10Do you maintain lot separation duringManufacturing?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Packaging?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Storage?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  5.11Do you maintain records of use, maintenance for process equipment, in order to demonstrate the traceability in batches, product processed and personnel?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.12Are computers used to store records of manufacture, testing, storage or distribution for the product you supply?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.12.1If yes, have these computer systems been validated (i.e.. have the complete life cycles of the systems been assessed and documented including stages of planning, specifications, programming, testing, commissioning, documentation, operation, monitoring and modifying)?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.13Do all product containers bear identification labels, e.g. stating batch/lot number, product name etc.?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.14Is there expiry or retest dates defined for all material?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.15Is there storage conditions defined for all material?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.16Is the product identifiable throughout the manufacturing process?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.17Is traceability of all raw materials used, maintained throughout manufacture?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.18Is there a procedure in place to prevent cross-contamination?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.19Are line clearances undertaken between product changes during manufacturing and labelling? (i.e. Where a variety of products are manufactured on one site, do you carry out an independent, recorded check, immediately prior to a production run to verify the areas are free from previous starting materials, products documentation and waste and that it is fit for use)?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.20Do you use dedicated equipment for the production of the product in question?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.20.1If no, please provide details of other product types manufactured using this equipment: FORMTEXT      5.21Is testing or inspection performed between processes or manufacturing stages?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.22Is testing or inspection performed on finished products?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.23Are rejected lots identified as such and separated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.24Do you perform a failure investigation in case of a reject?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.25Is reprocessing of rejected lots documented?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.26Do you have a procedure covering rework/reprocessing or recovery of material?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.27Is non-conforming final product ever blended with conforming product to bring it into specification?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  5.28Is there a documented procedure that clearly defines when blending of non-conforming product is allowed?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.29How long do you keep the analytical and production records (number of years)? FORMTEXT      Years5.30Do you have plant shutdowns (holidays, maintenance)?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.30.1If yes, which one(s)? FORMCHECKBOX main FORMCHECKBOX  hol5.31Do you have manufacturing alternatives/fall back?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 5.32How many weeks of inventory do you have for the product(s) involved:5.32.1Raw materials? FORMTEXT      5.32.2Semi-finished product? FORMTEXT      5.32.3Finished product? FORMTEXT       Materials Control6.1Do you have an approved supplier list?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.2Do you have agreements in place with all your suppliers that require them to notify you of any change in raw material or the manufacturing process of the product supplied?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.3Do you have written specifications for all incoming raw material?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.4Who is responsible for establishing and approving the specifications of raw materials? FORMTEXT      6.5Do you require a manufacturer s certificate of analysis for all material received in the company?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.6Are Certificates of Analysis routinely compared against a written specification?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.7Do you routinely test receipted materials to verify conformance with the supplier certification?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.8Do you have procedures for the control of raw materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.9Are records kept that show full traceability of raw materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.10Do you maintain information records for raw materials which include the following:Your lot Identity? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Suppliers Lot No?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Date of Receipt?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Quantity?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Suppliers name?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Shelf Life?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Test Results?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Specification?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Accepted/Rejected?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Retained Sample? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.11Please describe how material is issued from stock: FORMTEXT      6.12Do you have defined areas for Receipt, Identification, Sampling and Quarantine of incoming materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.13Are scheduled stock checks performed?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 6.14Do you have a rework/reprocess policy?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  Quality Control7.1Is Quality Control (QC) independent of Production?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.2Please describe the QC laboratory facilities and the tests these laboratories are capable of performing: FORMTEXT      7.3Are records kept of all samples that are submitted to the laboratories?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.4If so, do these records include the following:Date sample received?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Identity of samples? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Results of testing?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Date sample taken?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.5Are there formal written procedures for all performed tests?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.6Are the analytical methods validated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.7Are control samples routinely run with assays?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.8Are analytical calculations checked by a second person?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.9Do you perform trend analysis on analytical results?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.10Are the results of reference standard testing maintained on file?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.11Is there a procedure for documenting and investigating out-of-specification results?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.12Do you use any contract laboratories?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.13Have you qualified/evaluated these contract laboratories?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.14What types of testing is contracted out? FORMTEXT      7.15Are quality standards or written control procedures available for:Starting materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX In-process control?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Physical identification at all stages (e.g. labelling of semi-finished products)?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Finished products?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Microbiological control?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  7.16Are records kept of all control results?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.16.1If yes, for how long do you keep those records? FORMTEXT      Years7.17Is your critical analytical laboratory equipment fully qualified?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.18Is there a maintenance plan/procedure for laboratory equipment?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.18.1If yes:7.18.1.1Do you have a calibration scheme?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.18.1.2Do you have calibration instructions?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.18.1.3Do you keep all records of calibration performances?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.19Does any laboratory equipment have software control?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.19.1If yes:7.19.1.1Is the software validated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.19.1.2Are modifications of software (or its use) implemented by laboratory personnel?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.19.1.3Is there a procedure concerning change of software and its copying?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.19.1.4Is the security of software controlled?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.20Are samples of end product taken by appropriate trained personnel?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.21Which sampling plan do you use:7.21.1For starting materials? FORMTEXT      7.21.2For finished products? FORMTEXT      7.22Do you analyse each sample?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.23Do you keep retain samples of each lot?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 7.24For how long do you keep retain samples? FORMTEXT      Years7.25Is there a procedure in place to establish and manage reference standards?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  Quality Assurance8.1Is there an independent Quality Assurance (QA) department within the company?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.2Who is responsible for evaluation and approval:of specifications of end products? FORMTEXT      of critical manufacturing process parameters? FORMTEXT      8.3Do you have procedures covering the release or rejection of material?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.4Who is responsible for release and reject of your end product? FORMTEXT      8.5On which quality data do you base the release of the product? FORMTEXT      8.6Are batch records reviewed / approved before the batch is dispatched?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.7Are deviations and non-conformances investigated, documented and filed?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.8Do you communicate doubts regarding the quality of the product to the customers?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.8.1Even when the product is still within specification?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.9Would you notify your Customer of any significant deviations that occur during manufacturing?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.10Do you introduce changes according to a written procedure?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.11Do you inform your customers about changes? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.11.1If yes, how do you inform them? FORMTEXT      8.11.2Do you wait for approval of customers on major changes?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.11.3Would you notify your Customer in writing prior to implementing significant changes in analytical test methods, specifications or manufacturing procedures/process, use of raw material source form animal, human or vegetable origin?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.11.4Would you notify your Customer in writing prior to implementing major changes in plant, site of production or contract manufacturing? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.12Describe how senior management is informed of quality related issues: FORMTEXT      8.13Do you supply a Certificate of Analysis with each batch?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.13.1If  YES , will the Certificate of Analysis include actual analytical results?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 8.14Will you supply a Certificate of Sterilization with each batch?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  Packaging, Labelling and Shipping9.1If containers are reused, are they cleaned via validated cleaning procedures and inspected before use?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.2Are container labels reconciled and the number of labels printed, used and destroyed recorded?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.3Is each bag/container labelled with the lot/batch no.?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.4Will each bag/container on a pallet have the lot/batch no. and/or description clearly visible on it?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.5Do you keep records of all shipments to customers, including batch number and quantity?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.6Do you use your own transport for shipping to customers or do you use a contractor?Supplier- Owned  FORMCHECKBOX Contractor  FORMCHECKBOX  N/A  FORMCHECKBOX 9.7If you use a contractor, Do you have an agreed contract between parties which specifies required shipping conditions for materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.7.1If yes, have they been evaluated?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.8Is the shipping temperature controlled?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.9Have stability studies for temperature controlled shipments been performed?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.10Are written instructions available forPackaging components?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Packaging operation?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Labels and labelling?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.11Does the labelling procedure emphasise special precautions to prevent unintentional mix-up or substitution?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.12Do you maintain lot separation during packaging?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.13Are you prepared to meet packaging and labelling requirements from your customers?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.14Does your labelling indicate:Name and quality?DH      . 0 2 < > h l żr`ThvVhs.5OJQJ#jhE hs.OJQJU#jhE hs.OJQJU"jhs.OJQJUmHnHu#j&hE hs.OJQJUhs.OJQJjhs.OJQJUhs.5OJQJhvVh CJ$OJQJaJ$h CJ$OJQJaJ$h~X!CJ$OJQJaJ$h $CJ$OJQJaJ$h,OJQJFHp}ppp <<$Ifgdmbwkd$$Ifl$v(  t 0v(644 lap $Ifgd  @ _RRR <<$Ifgdmbkds$$IfleF ~$   t0v(6    44 lap@ B j _P & Fx$Ifgds.kd$$IflF ~$    t0v(6    44 lapj l v  H {n{{ <<$Ifgd? 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$5E7 t0m(644 la <<$Ifgdmg}֑>kd $$IflrU $5E7 t0m(644 la <<$IfgdmӑԑՑّڑswx͹͓ͯ͛}iUͯ'jhPYhs[OJQJU^J'j2hPYhs[OJQJU^Jhk+ hs[OJQJh9khs[OJQJhs[OJQJ'jhPYhs[OJQJU^Jhs[OJQJ^J'jfhPYhs[OJQJU^JhShs[OJQJ^J!jhShs[OJQJU^J'jhPYhs[OJQJU^J!֑s>kdN$$IflrU $5E7 t0m(644 la <<$Ifgdm)*+-12ź͇͛}iźU'j~hPYhs[OJQJU^J'j4hPYhs[OJQJU^Jhs[OJQJ^J'jhPYhs[OJQJU^J'jXhPYhs[OJQJU^Jhk+ hs[OJQJh9khs[OJQJhs[OJQJhShs[OJQJ^J!jhShs[OJQJU^J'jhPYhs[OJQJU^J!,>kd$$IflrU $5E7 t0m(644 la <<$Ifgdm,-2ƓK>>>>> <<$Ifgdmkd$$IflrU $5E7 t0m(644 laÓēœǓ˓̓)*+-/01?᧜ᜑ{g'jhPYhs[OJQJU^J'jhPYhs[OJQJU^JUhk+ hs[OJQJh9khs[OJQJhs[OJQJ'jZhPYhs[OJQJU^Jhs[OJQJ^J'jhPYhs[OJQJU^JhShs[OJQJ^J!jhShs[OJQJU^J#ƓǓ̓K>1>> <<$Ifgdk+ <<$Ifgdmkd$$IflrU $5E7 t0m(644 la<+ & F!<<$Ifgds[kd$$IflrU $6;7 t0m(644 la <<$IfgdmYes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX The site of manufacturing?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX The lot number?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Our order number?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Our code number?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  9.15Do you use re-usable containers?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.15.1If yes: Do you have procedures to take special precautions to avoid cross-contamination in this case?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.16Do you have your own transportation system?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.16.1If yes:Do you have a SQAS assessment report?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX Valid date of the SQAS report :  FORMTEXT      -- FORMTEXT      -- FORMTEXT      9.17Do you have a Quality-/Safety selection system for contracting carriersYes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.18Do you have a regular carrier for your goods?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.18.1If yes: What is the name of this company? FORMTEXT      Who is the carrier's agent? FORMTEXT      9.19Do you contact your customer in case of delay?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.20Does your transport system make use of a tracking report?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.21Does your carrier have a Quality Manual?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.22To which norm is this quality system related? FORMTEXT      9.23Is this system certified by an accredited third party auditing body?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.23.1If yes, which one(s)? FORMTEXT      9.24Does your carrier have a SQAS assessment report? Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.24.1If yes, valid date of the SQAS report :  FORMTEXT      -- FORMTEXT      -- FORMTEXT      9.25Does your carrier provide documented evidence of proper storage conditions during transportation?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.26Are transportations insured?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.27Do you have one or more substitute carriers?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.27.1If yes, which one(s)?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.27.2Does the substitute carrier(s) have a SQAS assessment report?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.27.2.1Valid date of the SQAS report :  FORMTEXT      -- FORMTEXT      -- FORMTEXT      9.27.3Does your substitute carrier have a certified person:  Safety-advisor transport dangerous materials (road/rail) ?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.27.4Please enclose a copy of the certificate:Ref:  FORMTEXT      9.28Does the Safety-advisor make annually reports to the highest management about the transport- activities of the company with respect to dangerous materials?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  9.29In case of liquid productsYes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.29.1Do you use dedicated tankers?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.29.2Do you require cleaning of road tankers after every use?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.29.3Are cleaning certificates kept by the driver?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX 9.29.4Are cleaning certificates available for inspection by us?Yes  FORMCHECKBOX No  FORMCHECKBOX N/A  FORMCHECKBOX  Safety, Health and Environment (SHE)10.1Do you have an operational management system(s) for Safety, Health and Environment (SHE)?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.1.1If so, are these systemsa. based on an international standard (ISO 9001/14001/18001)?Yes  FORMCHECKBOX No  FORMCHECKBOX b. certified by a accredited third party auditing body?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.2Do you have a dedicated organisation for safety, health and environment?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.3How many people are employed in this organisation? 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airYes  FORMCHECKBOX No  FORMCHECKBOX discharge of waste waterYes  FORMCHECKBOX No  FORMCHECKBOX disposal of hazardous wasteYes  FORMCHECKBOX No  FORMCHECKBOX protection against/remediation of soil pollutionYes  FORMCHECKBOX No  FORMCHECKBOX risk control and reductionYes  FORMCHECKBOX No  FORMCHECKBOX nuisance by noise/odourYes  FORMCHECKBOX No  FORMCHECKBOX occupational safetyYes  FORMCHECKBOX No  FORMCHECKBOX 10.8Does your site operate its own wastewater treatment installation?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.9Is your site controlled by regular inspections of authorities in the field of safety, health and environment?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.9.1Please specify FORMTEXT      10.10Is your personnel instructed on the handling of any kind of hazardous materials that you use and on how to act in case of unwanted events?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.11Do you have an adequate emergency response plan and organisation?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.12Do you run SHE (compliance/performance) audits?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.13Do you have a certified person: Safety-advisor transport dangerous materials (road/rail)?Yes  FORMCHECKBOX No  FORMCHECKBOX 10.13.1Please enclose a copy of the certificateRef:  FORMTEXT      10.13.2Does the Safety-advisor make annually reports to the highest management about the transport activities of the company with respect to dangerous materials?Yes  FORMCHECKBOX No  FORMCHECKBOX      Supplier Quality Questionnai67<ޘ ^QQQQ <<$Ifgdmkd5!$$Ifl\U $}77 t0m(644 la  VW^QQQ <<$Ifgdmkd"$$Ifl\U $}77 t0m(644 laWXYjqdSdd & F <<$IfgdDEh <<$Ifgdmkdg#$$IflF$}n t0m(6    44 laUXYjno}~Ùęřəʙؙٙڙܙݙ  пЫпЗпЃпoп['j''hPYhOJQJU^J'j%hPYhOJQJU^J'j%hPYhOJQJU^J'jW$hPYhOJQJU^J'j#hPYhOJQJU^J!jhShOJQJU^JhShOJQJ^JhhOJQJh9khOJQJhShDEhOJQJ^J#ƙۙ^Q@QQ & F <<$IfgdDEh <<$Ifgdmkd$$$Ifl\U $}77 t0m(644 laۙܙݙ$^Q@QQ & F <<$IfgdDEh <<$Ifgdmkdg&$$Ifl\U $}77 t0m(644 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