Supplier Quality Questionnaire

Supplier Questionnare - Section E Extended Quality Questionnaire Page 1 of 15

E. Extended Quality Questionnaire

Material Brand Name Chemical Name (if applicable) Product Code

1. General Information
1.1. Are customer audits and/or inspections by agencies permitted? Yes No

1.2 Is the decision to release or reject a product for sale independent from production? Yes No

1.3. Who is signing the Certificate of Analysis (Analytical Report)?

1.4 Who is responsible for the final product release?

1.5. Who is responsible for contacts with us concerning quality

matters?
1.6 What kind of product do you manufacture
▪ Bulk raw materials? Yes No
▪ Bulk raw materials for pharmaceuticals? Yes No
▪ Active pharmaceutical ingredients? Yes No
▪ Technical products? Yes No
▪ Packaging material? Yes No
▪ Others? Yes No
Please, specify:

1.7 Please, give a brief flow diagram of the process, including information about where in- Ref:
process controls are performed. Special attention must be given to the last step in the
process e.g. reagents, precipitation agent and solvents
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2. Personnel, Training and Education

2.1 Do you have written job descriptions for all personnel? Yes No N/A
2.2 Do you have procedures that document how you perform training? Yes No N/A
2.3 Do you maintain records of the training? Yes No N/A
Is your personnel aware that the products supplied are used for the
2.4 Yes No N/A
manufacturing of active pharmaceutical ingredients?
2.5 Does the Training Program in place have the following elements:
2.5.1 Formal Introduction to Regulatory Guidance (GMP, ISO, etc.) Yes No N/A
2.5.2 New Hire Program Yes No N/A
Specific training e.g. clean room or handling toxic, infectious or sensitising
2.5.3 Yes No N/A
materials?
2.5.4 Periodic assessment of practical effectiveness? Yes No N/A
2.5.5 Periodic refresher training programs for established employees? Yes No N/A
2.5.6 At the start of new product manufacturing? Yes No N/A
2.5.7 When new methods are used? Yes No N/A
2.5.8 Quality techniques for production people? Yes No N/A
2.6 Does your training program emphasise:
2.6.1 Product integrity? Yes No N/A
2.6.2 Hygiene? Yes No N/A
2.6.3 Cleanliness? Yes No N/A
2.6.4 Other? Yes No N/A
Please specify:
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3. Facility and Utilities

3.1 Were the premises designed or adapted for the present use? designed adapted
3.2 Are there separate areas for:
3.2.1 ▪ Handling of starting materials? Yes No N/A
3.2.2 ▪ Manufacturing? Yes No N/A
▪ Quarantined finished products or are other control systems in
3.2.3 Yes No N/A
place?
3.2.4 ▪ Approved finished products? Yes No N/A
3.2.5 ▪ Packaging and dispatch? Yes No N/A
3.2.6 ▪ Rest and eating? Yes No N/A
3.3 Does the present design prevent:
3.3.1 ▪ Chemical contamination? Yes No N/A
3.3.2 ▪ Physical contamination? Yes No N/A
3.3.3 ▪ Microbial contamination? Yes No N/A
3.4 Are your working-rooms:
3.4.1 ▪ Of proper size for the intended functions? Yes No N/A
3.4.2 ▪ Satisfactorily lighted, air-conditioned? Yes No N/A
3.4.3 ▪ Clean and cleaned-up? Yes No N/A
3.4.4 ▪ Designed to avoid (cross-) contamination? Yes No N/A
3.4.5 ▪ Supplied with security and fire protection measurements? Yes No N/A
3.5 Do you have written Good House Keeping Procedures? Yes No N/A
3.5.1 If yes, do you maintain follow- up records of these procedures? Yes No N/A
3.6 Do your manufacturing locations follow Good Manufacturing Practices? Yes No N/A
3.7 Are your sites inspected by the FDA or national (health) authorities? Yes No N/A
3.8 Are plant supply pipelines identified and labelled? Yes No N/A
Do you monitor the quality of the water used to prepare standards and
3.9 Yes No N/A
reagents?
Do you monitor the quality of the water used during the manufacturing
3.10 Yes No N/A
process?
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4. Machines and Equipment

4.1 Is the production line multi purpose or single purpose? multi single

4.1.1 lf multi, what other products do you manufacture there?

Is there a maintenance and preventative maintenance program for all

4.2 Yes No N/A
pieces of equipment?
4.3 Do you have written maintenance and calibration procedures for critical Yes No N/A
equipment?
4.4 Can all critical apparatus and devices easily be recognised as such, e.g. by Yes No N/A
calibration stickers?
4.5 Are these calibrations traceable back to national standards? Yes No N/A
4.6 Do you retain records of calibration as evidence of control? Yes No N/A
4.7 Is there a cleaning plan/procedure for production machines, equipment? Yes No N/A
4.8 Have the cleaning and sterilisation processes been validated? Yes No N/A
4.9 Is any manufacturing equipment software controlled? Yes No N/A
4.10 Do you have a documented procedure for the validation of all test and Yes No N/A
measuring equipment used to demonstrate the conformance of product
to the specified requirements?
4.11 Do you retain records of validation as evidence of control? Yes No N/A
4.11.1 If yes,
▪ Is the software validated? Yes No N/A
▪ Are modifications of software (or its use) implemented by Yes No N/A
manufacturing personnel?
▪ Is there a procedure concerning change of software and its Yes No N/A
copying?
▪ Is the security of software controlled? Yes No N/A
4.12 Do you contract out any of the following services
4.12.1 Instrument Calibration? Yes No N/A
4.12.2 Preventative / Breakdown Maintenance? Yes No N/A
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5. Production and Process Control

5.1 Is your manufacturing process validated? Yes No
5.1.1 If not, do you have plans to do so? Yes No
5.1.1.1 If you do: what is your target date for completion?
5.2 How do you define your lot/batch?

5.3 How and by whom are lot/batch numbers assigned?

5.4 What is your normal lot/batch size?

5.5 Does each lot/batch have an identification number? Yes No N/A

5.6 If, for capacity reasons, you combine material coming from more than one particular piece or part of process
equipment into one lot/batch:
5.6.1 Is the lot/batch being homogenised prior to packaging? Yes No N/A

5.6.2 Is the homogenisation operation validated? Yes No N/A

5.7 Do you manufacture according to a written procedure for each product Yes No N/A
supplied to the market?
5.8 Are these procedures approved by QA? Yes No N/A
5.9 Do you have a batch record for each batch/lot manufactured? Yes No N/A
5.9.1 If yes, do the batch records detail the following:
▪ Description, Lot Number & Quantities of Material used? Yes No N/A
▪ Processing Conditions (Temperature, Times etc)? Yes No N/A
▪ The identification of the Person who performed the particular Yes No N/A
step?
▪ Results of any In-process tests? Yes No N/A
▪ All deviations from standard conditions? Yes No N/A
▪ All cleaning operations carried out before & after batch Yes No N/A
manufacture?
5.9.2 If yes, for how long do you keep the batch records? Yes No N/A
5.9.3 If yes, are these records formally checked and approved by QA? Yes No N/A
5.10 Do you maintain lot separation during
▪ Manufacturing? Yes No N/A
▪ Packaging? Yes No N/A
▪ Storage? Yes No N/A
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5.11 Do you maintain records of use, maintenance for process equipment, in Yes No N/A
order to demonstrate the traceability in batches, product processed and
personnel?
5.12 Are computers used to store records of manufacture, testing, storage or Yes No N/A
distribution for the product you supply?
5.12.1 If yes, have these computer systems been validated (i.e.. have the Yes No N/A
complete life cycles of the systems been assessed and documented
including stages of planning, specifications, programming, testing,
commissioning, documentation, operation, monitoring and modifying)?
5.13 Do all product containers bear identification labels, e.g. stating batch/lot Yes No N/A
number, product name etc.?
5.14 Is there expiry or retest dates defined for all material? Yes No N/A
5.15 Is there storage conditions defined for all material? Yes No N/A
5.16 Is the product identifiable throughout the manufacturing process? Yes No N/A
5.17 Is traceability of all raw materials used, maintained throughout Yes No N/A
manufacture?
5.18 Is there a procedure in place to prevent cross-contamination? Yes No N/A
5.19 Are line clearances undertaken between product changes during Yes No N/A
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)?
5.20 Do you use dedicated equipment for the production of the product in Yes No N/A
question?
5.20.1
If no, please provide details of other product types manufactured using
this equipment:

5.21 Is testing or inspection performed between processes or manufacturing Yes No N/A

stages?
5.22 Is testing or inspection performed on finished products? Yes No N/A
5.23 Are rejected lots identified as such and separated? Yes No N/A
5.24 Do you perform a failure investigation in case of a reject? Yes No N/A
5.25 Is reprocessing of rejected lots documented? Yes No N/A
5.26 Do you have a procedure covering rework/reprocessing or recovery of Yes No N/A
material?
5.27 Is non-conforming final product ever blended with conforming product to Yes No N/A
bring it into specification?
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5.28 Is there a documented procedure that clearly defines when blending of Yes No N/A
non-conforming product is allowed?
5.29 How long do you keep the analytical and production records (number of
Years
years)?
5.30 Do you have plant shutdowns (holidays, maintenance)? Yes No N/A
5.30.1 If yes, which one(s)? main hol
5.31 Do you have manufacturing alternatives/fall back? Yes No N/A
5.32 How many weeks of inventory do you have for the product(s) involved:
5.32.1 ▪ Raw materials?
5.32.2 ▪ Semi-finished product?
5.32.3 ▪ Finished product?
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6. Materials Control
6.1 Do you have an approved supplier list? Yes No N/A
6.2 Do you have agreements in place with all your suppliers that require
them to notify you of any change in raw material or the manufacturing Yes No N/A
process of the product supplied?
6.3 Do you have written specifications for all incoming raw material? Yes No N/A
6.4 Who is responsible for establishing and approving the specifications of
raw materials?
6.5 Do you require a manufacturer’s certificate of analysis for all material
Yes No N/A
received in the company?
6.6 Are Certificates of Analysis routinely compared against a written
Yes No N/A
specification?
6.7 Do you routinely test receipted materials to verify conformance with the
Yes No N/A
supplier certification?
6.8 Do you have procedures for the control of raw materials? Yes No N/A
6.9 Are records kept that show full traceability of raw materials? Yes No N/A
6.10 Do you maintain information records for raw materials which include the following:
▪ Your lot Identity? Yes No N/A
▪ Suppliers Lot No? Yes No N/A
▪ Date of Receipt? Yes No N/A
▪ Quantity? Yes No N/A
▪ Suppliers name? Yes No N/A
▪ Shelf Life? Yes No N/A
▪ Test Results? Yes No N/A
▪ Specification? Yes No N/A
▪ Accepted/Rejected? Yes No N/A
▪ Retained Sample? Yes No N/A
6.11 Please describe how material is issued from stock:

6.12 Do you have defined areas for Receipt, Identification, Sampling and
Yes No N/A
Quarantine of incoming materials?
6.13 Are scheduled stock checks performed? Yes No N/A
6.14 Do you have a rework/reprocess policy? Yes No N/A
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7. Quality Control
7.1 Is Quality Control (QC) independent of Production? Yes No N/A
7.2 Please describe the QC laboratory facilities and the tests these
laboratories are capable of performing:

7.3 Are records kept of all samples that are submitted to the laboratories? Yes No N/A
7.4 If so, do these records include the following:
▪ Date sample received? Yes No N/A
▪ Identity of samples? Yes No N/A
▪ Results of testing? Yes No N/A
▪ Date sample taken? Yes No N/A
7.5 Are there formal written procedures for all performed tests? Yes No N/A
7.6 Are the analytical methods validated? Yes No N/A
7.7 Are control samples routinely run with assays? Yes No N/A
7.8 Are analytical calculations checked by a second person? Yes No N/A
7.9 Do you perform trend analysis on analytical results? Yes No N/A
7.10 Are the results of reference standard testing maintained on file? Yes No N/A
7.11 Is there a procedure for documenting and investigating out-of-
Yes No N/A
specification results?
7.12 Do you use any contract laboratories? Yes No N/A
7.13 Have you qualified/evaluated these contract laboratories? Yes No N/A
7.14 What types of testing is contracted out?

7.15 Are quality standards or written control procedures available for:

▪ Starting materials? Yes No N/A
▪ In-process control? Yes No N/A
▪ Physical identification at all stages (e.g. labelling of semi-finished
Yes No N/A
products)?
▪ Finished products? Yes No N/A
▪ Microbiological control? Yes No N/A
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7.16 Are records kept of all control results? Yes No N/A

7.16.1 If yes, for how long do you keep those records? Years
7.17 Is your critical analytical laboratory equipment fully qualified? Yes No N/A
7.18 Is there a maintenance plan/procedure for laboratory equipment? Yes No N/A
7.18.1 If yes:
7.18.1.1 Do you have a calibration scheme? Yes No N/A
7.18.1.2 Do you have calibration instructions? Yes No N/A
7.18.1.3 Do you keep all records of calibration performances? Yes No N/A
7.19 Does any laboratory equipment have software control? Yes No N/A
7.19.1 If yes:
7.19.1.1 Is the software validated? Yes No N/A
7.19.1.2 Are modifications of software (or its use) implemented by laboratory
Yes No N/A
personnel?
7.19.1.3 Is there a procedure concerning change of software and its copying? Yes No N/A
7.19.1.4 Is the security of software controlled? Yes No N/A
7.20 Are samples of end product taken by appropriate trained personnel? Yes No N/A
7.21 Which sampling plan do you use:
7.21.1 ▪ For starting materials?
7.21.2 ▪ For finished products?
7.22 Do you analyse each sample? Yes No N/A
7.23 Do you keep retain samples of each lot? Yes No N/A
7.24 For how long do you keep retain samples? Years
7.25 Is there a procedure in place to establish and manage reference
Yes No N/A
standards?
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8. Quality Assurance
8.1 Is there an independent Quality Assurance (QA) department within the
Yes No N/A
company?
8.2 Who is responsible for evaluation and approval:
▪ of specifications of end products?
▪ of critical manufacturing process parameters?
8.3 Do you have procedures covering the release or rejection of material? Yes No N/A
8.4 Who is responsible for release and reject of your end product?
8.5 On which quality data do you base the release of the product?
8.6 Are batch records reviewed / approved before the batch is dispatched? Yes No N/A
8.7 Are deviations and non-conformances investigated, documented and
Yes No N/A
filed?
8.8 Do you communicate doubts regarding the quality of the product to the
Yes No N/A
customers?
8.8.1 Even when the product is still within specification? Yes No N/A
8.9 Would you notify your Customer of any significant deviations that occur
Yes No N/A
during manufacturing?
8.10 Do you introduce changes according to a written procedure? Yes No N/A
8.11 Do you inform your customers about changes? Yes No N/A
8.11.1 If yes, how do you inform them?
8.11.2 Do you wait for approval of customers on major changes? Yes No N/A
8.11.3 Would you notify your Customer in writing prior to implementing
significant changes in analytical test methods, specifications or
Yes No N/A
manufacturing procedures/process, use of raw material source form
animal, human or vegetable origin?
8.11.4 Would you notify your Customer in writing prior to implementing major
Yes No N/A
changes in plant, site of production or contract manufacturing?

Describe how senior management is informed of quality related

8.12
issues:

8.13 Do you supply a Certificate of Analysis with each batch? Yes No N/A
8.13.1 If ‘YES’, will the Certificate of Analysis include actual analytical results? Yes No N/A
8.14 Will you supply a Certificate of Sterilization with each batch? Yes No N/A
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9. Packaging, Labelling and Shipping

9.1 If containers are reused, are they cleaned via validated cleaning procedures
Yes No N/A
and inspected before use?
9.2 Are container labels reconciled and the number of labels printed, used and
Yes No N/A
destroyed recorded?
9.3 Is each bag/container labelled with the lot/batch no.? Yes No N/A
9.4 Will each bag/container on a pallet have the lot/batch no. and/or
Yes No N/A
description clearly visible on it?
9.5 Do you keep records of all shipments to customers, including batch number
Yes No N/A
and quantity?
9.6 Do you use your own transport for shipping to customers Supplier- Owned Contractor N/A
or do you use a contractor?
9.7 If you use a contractor, Do you have an agreed contract between parties
Yes No N/A
which specifies required shipping conditions for materials?
9.7.1 If yes, have they been evaluated? Yes No N/A
9.8 Is the shipping temperature controlled? Yes No N/A
9.9 Have stability studies for temperature controlled shipments been
Yes No N/A
performed?
9.10 Are written instructions available for
Packaging components? Yes No N/A
Packaging operation? Yes No N/A
Labels and labelling? Yes No N/A
9.11 Does the labelling procedure emphasise special precautions to prevent
Yes No N/A
unintentional mix-up or substitution?
9.12 Do you maintain lot separation during packaging? Yes No N/A
9.13 Are you prepared to meet packaging and labelling requirements from your
Yes No N/A
customers?
9.14 Does your labelling indicate:
▪ Name and quality? Yes No N/A
▪ The site of manufacturing? Yes No N/A
▪ The lot number? Yes No N/A
▪ Our order number? Yes No N/A
▪ Our code number? Yes No N/A
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9.15 Do you use re-usable containers? Yes No N/A

9.15.1 If yes: Do you have procedures to take special precautions to avoid cross-
Yes No N/A
contamination in this case?
9.16 Do you have your own transportation system? Yes No N/A
9.16.1 If yes:
Do you have a SQAS assessment report? Yes No N/A
Valid date of the SQAS report : -- --
9.17 Do you have a Quality-/Safety selection system for contracting carriers Yes No N/A
9.18 Do you have a regular carrier for your goods? Yes No N/A
9.18.1 If yes:
What is the name of this company?
Who is the carrier's agent?
9.19 Do you contact your customer in case of delay? Yes No N/A
9.20 Does your transport system make use of a tracking report? Yes No N/A
9.21 Does your carrier have a Quality Manual? Yes No N/A
9.22 To which norm is this quality system related?
9.23 Is this system certified by an accredited third party auditing body? Yes No N/A
9.23.1 If yes, which one(s)?
9.24 Does your carrier have a SQAS assessment report? Yes No N/A
9.24.1 If yes, valid date of the SQAS report : -- --
9.25 Does your carrier provide documented evidence of proper storage
Yes No N/A
conditions during transportation?
9.26 Are transportations insured? Yes No N/A
9.27 Do you have one or more substitute carriers? Yes No N/A
9.27.1 If yes, which one(s)? Yes No N/A
9.27.2 Does the substitute carrier(s) have a SQAS assessment report? Yes No N/A
9.27.2.1 Valid date of the SQAS report : -- --
9.27.3 Does your substitute carrier have a certified person: “Safety-advisor
Yes No N/A
transport dangerous materials (road/rail)”?
9.27.4 Please enclose a copy of the certificate: Ref:
9.28 Does the Safety-advisor make annually reports to the highest
management about the transport- activities of the company with respect Yes No N/A
to dangerous materials?
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9.29 In case of liquid products Yes No N/A

9.29.1 Do you use dedicated tankers? Yes No N/A
9.29.2 Do you require cleaning of road tankers after every use? Yes No N/A
9.29.3 Are cleaning certificates kept by the driver? Yes No N/A
9.29.4 Are cleaning certificates available for inspection by us? Yes No N/A
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10. Safety, Health and Environment (SHE)

10.1 Do you have an operational management system(s) for Safety, Health and
Yes No
Environment (SHE)?
10.1.1 If so, are these systems
a. based on an international standard (ISO 9001/14001/18001)? Yes No
b. certified by a accredited third party auditing body? Yes No
10.2 Do you have a dedicated organisation for safety, health and environment? Yes No
10.3 How many people are employed in this organisation?
10.4 Have you identified all relevant SHE aspects of your activities and all relevant legal
Yes No
requirements you have to comply with?
10.5 Do you have a structured SHE program, which is regularly monitored and updated? Yes No
10.6 Does your site comply with all licenses under relevant laws (Nuisance Act,
Environmental Protection Act, Integrated Pollution Prevention, Hazardous Waste, Yes No
etc.)?
10.7 Are the following subjects regulated by law and/or specific standards:
▪ emissions to air Yes No
▪ discharge of waste water Yes No
▪ disposal of hazardous waste Yes No
▪ protection against/remediation of soil pollution Yes No
▪ risk control and reduction Yes No
▪ nuisance by noise/odour Yes No
▪ occupational safety Yes No
10.8 Does your site operate its own wastewater treatment installation? Yes No
10.9 Is your site controlled by regular inspections of authorities in the field of safety, health
Yes No
and environment?
10.9.1 Please specify
10.10 Is your personnel instructed on the handling of any kind of hazardous materials that
Yes No
you use and on how to act in case of unwanted events?
10.11 Do you have an adequate emergency response plan and organisation? Yes No
10.12 Do you run SHE (compliance/performance) audits? Yes No
10.13 Do you have a certified person: “Safety-advisor transport dangerous materials
Yes No
(road/rail)”?
10.13.1 Please enclose a copy of the certificate Ref:
10.13.2 Does the Safety-advisor make annually reports to the highest management about the
Yes No
transport activities of the company with respect to dangerous materials?