3rd Party Manufacturer Qualification Questionnaire

1.1Company name

1.2Manufacturing site address and contact details:

1.3Contact details for quality and manufacturing:

2.1Do you have an organisational chart?

If yes, please provide a copy of the organisational chart.

2.2Do you have position descriptions?

If yes, please provide a copy of the position descriptions for the head of quality and manufacturing.

2.3Is the quality department independent of manufacturing?

2.4Please confirm the approximate number of employees in each of the following areas?

2.5Do you have specific health requirements for employees and contractors?

If yes, please explain the specific health requirements for employees and contractors.

2.6Do you have specific dress regulations for employees and contractors?

If yes, please explain the specific dress regulations for employees and contractors.

2.7Do you have procedures for training?

2.8Do you clearly identify the training requirements for employees and contractors?

2.9Do you provide good manufacturing practice (GMP), cleanliness and quality awareness training for employees and contractors?

2.10How is training conducted and how often?

2.11Do you verify training of employees and contractors by testing?

2.12Do you maintain training records for employees and contractors?

3.1What types of products do you manufacture at the site?

Please provide details of other products you manufacture at the site.

3.2Do you manufacture any of the following classes of products at the site?

3.3Is the site licensed/certified by any of the following authorities? If yes, please provide a copy of any current licence/certification.

Please provide details of all other licences/certifications.

3.4Do you comply with ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients?

If no, do you comply with any other code of practice for manufacturers of active pharmaceutical ingredients?

If yes, please provide details of any other code of practice for manufacturers of active pharmaceutical ingredients complied with, and a copy of any certificate of compliance.

3.5Do you sub-contract any part of the manufacturing process or testing of the starting materials or raw materials?

If yes, please provide details of the manufacturing process or testing that is sub-contracted and provide a copy of any current licence/certification.

3.6If you sub-contract any part of the manufacture of the product, how is the product transported between sites?

3.7Are you willing to undergo an audit or inspection?

3.8Have you been audited by any other companies?

If yes, are you prepared to disclose the companies?

If yes, please provide details of the companies and the dates of the last audits.

3.9Do you have general and product liability insurance?

If yes, please provide a summary of the insurance held, including the level of coverage.

4.1Do you have a Site Master File?

If yes, please provide a copy of the Site Master File.

If no, can you provide a copy of the site and facility plan?

If yes, please provide a copy of the site and facility plan.

4.2How long have you been located at this site?

4.3What is the approximate size of the site in square metres?

4.4How is access/security to the site controlled?

4.5What is the approximate size of the facility in square metres?

4.6What is the approximate age of the facility, and when were the last upgrades?

4.7What type of development surrounds the site?

4.8Do you have an air handling system for the product manufacturing?

If yes, please provide a diagram of the air handling system and confirm the operational parameters including temperature, humidity, air change rates and filter specifications.

4.9Do you control temperature?

4.10Do you monitor temperature?

If yes, please provide a copy of the procedures for monitoring temperature and explain how monitoring is performed and reviewed.

4.11Do you control relative humidity?

4.12Do you monitor relative humidity?

If yes, please provide a copy of the procedures for monitoring relative humidity and explain how monitoring is performed and reviewed.

4.13Do you use refrigerated storage?

If yes, do you monitor temperature?

If yes, please provide a copy of the procedures for monitoring temperature and explain how monitoring is performed and reviewed.

If yes, do you have an alarmed monitoring system?

If yes, please explain how the alarmed monitoring system operates.

4.14Do you use water at any step of the manufacturing process?

If yes, please provide a copy of the quality specification and confirm where it is sourced from.

4.15Do you have a water purification system?

If yes, please provide a copy of the sanitation procedures, a diagram of the water purification system, and confirm the operational parameters including capacity, flow rate, temperature and filter specifications.

4.16Are drains and wastes designed with adequate air breaks to prevent back flushing or siphoning of waste?

4.17Are pipes and services clearly labelled?

4.18Do you control raw material and product status?

4.19Do you have clearly designated approved, quarantined and rejected areas?

4.20Do you receive deliveries from bulk tankers?

If yes, do you have procedures and secured couplings to minimise the risk of incorrect coupling and unloading of deliveries from bulk tankers?

4.21Are bulk tankers dedicated?

If no, is a cleaning certificate required to be provided with each delivery?

4.22Do you have procedures for pest control?

If yes please provide a copy of the pest control procedures, and confirm what pesticides are approved for use.

4.23Do you have procedures for environmental monitoring?

If yes please provide a copy of the procedures for environmental monitoring, confirm the parameters that are monitored, and explain how environmental monitoring is performed and reviewed.

4.24Do you have specific controls on eating and smoking?

If yes, please provide details of the specific controls on eating and smoking.

4.25Are toilets, change rooms and eating areas separate from manufacturing areas and maintained in a sanitary condition?

4.26Do you have signs erected in toilets and change rooms to instruct employees on appropriate hand washing techniques before starting or returning to work?

4.27What is the active ingredient in the soap/disinfectant provided in the toilets and change rooms?

4.28Do you have appropriately shielded lighting?

5.1Are process equipment contact surfaces designed and constructed not to be reactive or additive?

5.2Are process equipment contact surfaces easily cleaned?

5.3Do you have procedures for the following aspects of process equipment?

5.4Do you keep records of the following maintenance activities for process equipment?

5.5Please indicate what process capabilities you have?

Please provide details of other process capabilities.

5.6Please provide the title and reporting structure of the person in charge of maintenance?

5.7Do you dedicate any process equipment to manufacture one raw material / product?

5.8Do you concurrently manufacture different raw materials/products in a common area?

If yes, please provide details of how you minimise the risk of cross contamination.

5.9Do you manufacture by lot or continuous process?

5.10Do you regularly calibrate the critical operational parameters of process equipment?

5.11Do you calibrate process equipment with standards that are traceable to a recognised standard?

5.12Do the procedures for maintenance specify the lubricants that can be used on specific process equipment?

5.13Do you approve lubricants prior to use?

5.14Do the procedures for cleaning specify the method of preparation, expiry date and dilution rates for the cleaning and sanitising agents that can be used?

5.15Do you approve the cleaning and sanitising agents prior to use?

5.16Do you use statistical process control techniques in manufacturing?

5.17Do you use metal detectors at any stage of manufacturing?

If yes, please provide details of what stage/s of manufacturing are they used and their limit of detection.

6.1Do you assign goods receivable numbers for starting materials?

If yes, please explain how goods receivable numbers are assigned, and what the goods receivable numbers look like.

6.2Do you follow the principles of first in first out (FIFO) or first expired first out (FEFO) stock rotation?

6.3Do you have a materials location system?

6.4Do you store more than one material per location?

6.5Do you assign lot/batch numbers for raw materials & products?

If yes, please explain how lot/batch numbers are assigned, and what the lot/batch numbers look like.

6.6Do you have a means of identifying the site of manufacture from lot/batch numbers if multiple manufacturing sites are used?

If yes, please explain how you can identify the site of manufacture from lot/batch numbers.

6.7Do you identify the site of manufacture on certificates of analysis?

6.8Do you guarantee to supply raw material/product with an expiry date greater than 12 months?

6.9Are the same raw materials/products produced in several forms and sizes?

If yes, does each form/size have unique item codes?

6.10Do you have procedures to notify customers in advance of late deliveries?

6.11Do you have procedures to ensure that unapproved raw material/products are not shipped to customers?

6.12Do you have procedures for handling rejected and returned raw material/products?

7.1Do you have a quality system?

If yes, please provide a brief overview of the quality system.

7.2Do you have a quality manual?

If yes, please provide the table of contents of the quality manual.

7.3Do you have procedures for environmental protection?

7.4Do you have procedures for disaster recovery to deal with man-made and/or natural disasters?

7.5Do you undertake regular reviews of the quality system?

If yes, please provide details of the frequency of the reviews and what is reviewed.

7.6Do you have a continuous quality improvement program?

7.7Do you have procedures that specify the quantity and identity of starting materials, equipment to be utilised and the critical processing parameters?

If yes, do they provide traceability back to the starting material goods receivable numbers?

7.8Do you blend multiple lots/batches of raw material and label as one lot/batch?

7.9Do you sequentially pack multiple lots/batches of raw material and label as one lot/batch?

7.10Do you have a means of identifying if a lot/batch of raw material has been reprocessed?

If yes, please explain how you can identify a lot/batch of raw material that has been reprocessed.

7.11Do you retain lot/batch records?

If yes, please confirm how long lot/batch records are retained.

7.12Are you willing to supply a copy of a recently completed lot/batch record for a typical raw material/product?

If yes, please provide a copy of a recently completed lot/batch record.

7.13Is the theoretical versus actual yield calculated on every batch of raw material / product manufactured?

7.14Do you have any of the following documents available for any raw material?

If yes, please provide details of any current documents that are available.

7.15Do you have standard operating procedures?

If yes, please provide a list of the standard operating procedures.

7.16Do you have specifications?

7.17Who approves standard operating procedures and specifications?

7.18Do you have procedures for sampling starting materials and raw materials?

7.19Do you follow statistical sampling plans?

7.20Who performs sampling?

7.21Do you have procedures for reviewing and updating procedures and specifications?

7.22Do you have procedures for change control?

7.23Do you have procedures for investigating non-conformances?

7.24Do you have a non-conformance database?

7.25Do you have procedures for corrective action and preventative action?

7.26Do you have a corrective action and preventative action database?

7.27Do you have procedures for risk management?

7.28Do you have procedures for internal and external audits?

If yes, please provide details of the frequency of audits, and explain what is reviewed.

7.29Are the results of internal and external audits documented and reviewed by management?

7.30Are corrective actions resulting from internal and external audits documented and verified for effectiveness?

7.31Do you have procedures in place to ensure that the distributor/trader and customer have agreed to any changes to specifications prior to them being implemented?

7.32Do you agree to provide prior notification before any of the following changes are implemented?

7.33Do you perform trend analysis on raw materials and products?

7.34Do you conduct product quality reviews on raw materials/products in accordance with ICH Q7A Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients or PICs GMP?

8.1Do you undertake cultivation of plants on your own farms?

If yes, please provide details of what cultivation activities you undertake.

8.2Do you provide seeds or propagation materials to farmers for particular plants?

If yes, please provide details of what seeds or propagation materials you provide.

8.3Do you employ qualified botanists?

If no, please provide details of how you perform authentication of plant materials prior to further processing.

8.4Do you have procedures for performing botanical authentication?

If yes, please provide a copy of the procedures for performing botanical authentication.

8.5Do you have a herbarium?

8.6Do you have a library of voucher specimens?

If yes, please provide a list of the voucher specimens including the botanical name, type of voucher specimen and where the authentication was performed.

8.7Do you comply with the WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants?

8.8Do you use any plants/plant extracts that are listed as endangered by the Convention on International / Trade in Endangered Species (CITES)?

If yes, please provide details of any plants/plant extracts you use that are listed as endangered by the Convention on International Trade in Endangered Species (CITES).

Quality Control - General Starting Materials

8.9Are bulk deliveries of starting materials tested before coupling and unloading?

8.10Do you ensure that certificates of analysis are supplied with every delivery of starting material?

8.11To what quality standard must starting materials comply with?

Please provide details of other quality standards starting materials comply with.

8.12Do you have specifications for starting materials & products?

If yes, are these specifications available to customers?

8.13Do you have test procedures for starting materials & products?

If yes, are these test procedures available to customers?

8.14Do you have specifications for packaging materials?

8.15Do you test starting materials?

8.16Do you test for heavy metals?

8.17Do you test for pesticide residues?

8.18Do you test for mycotoxins?

8.19Do you test for environmental contaminants?

8.20Do you test for veterinary residues?

8.21Do you test for residual solvents?

8.22Do you test packaging materials?

8.23Do you test every delivery of starting material?

If no, please provide details of what tests are performed on every delivery.

8.24Do you have procedures to allow reduced testing of starting materials?

If yes, please provide a copy of the reduced testing procedures.

8.25When reduced testing is performed, is it indicated on the certificate of analysis?

8.26Are inspection and testing results for starting materials reviewed by qualified laboratory personnel?

8.27Who has the authority to approve and reject starting materials?

8.28Do you retain inspection and testing records for each delivery of starting material?

If yes, please confirm how long inspection and testing records are retained.

8.29Do you retain retention samples of each delivery of starting material?

If yes, please confirm how long retention samples are retained.

8.30Do you retain the certificates of analysis provided by suppliers?

If yes, please confirm how long certificates of analysis are retained.

8.31Can you provide copies of inspection and testing records and certificates of analysis if requested?

8.32Do you have procedures for maintaining traceability of starting materials?

8.33Do you have procedures for receiving starting materials?

8.34Do you have procedures for approving starting materials?

8.35Do you have procedures for rejecting starting materials?

8.36Do you have procedures for vendor assurance of starting material suppliers?

8.37Do you maintain a list of the vendor assurance status of starting material suppliers?

8.38Do you have easily identifiable security seals on each container of starting material to ensure tampering can be recognised?

8.39Do you recover and reuse any starting materials in the manufacture of other raw materials?

If yes, please provide details of any starting materials that are recovered and reused in the manufacture of other raw materials, and explain what testing is undertaken.

8.40Are rejected starting materials ever reprocessed and reused?

If yes, please explain how rejected starting materials can be reprocessed.

8.41Do you use any form of sterilisation on starting materials?

If yes, please provide details on what forms of sterilisation are used and whether it is indicated on certificates of analysis.

8.42Do any of your raw materials contain animal derived ingredients?

9.1To what quality standard must Products comply with?

Please provide details of other quality standards Products comply with.

9.2Do you have specifications for raw materials/products?

If yes, are these specifications available to customers?

9.3Do you have test procedures for raw materials/prooducts?

If yes, are these test procedures available to customers?

9.4Do you test raw materials and all products?

9.5Do you test for heavy metals?

9.6Do you test for pesticide residues?

9.7Do you test for mycotoxins?

9.8Do you test for environmental contaminants?

9.9Do you test for veterinary residues?

9.10Do you test for residual solvents?

9.11Do you test every lot/batch of raw material/products?

If no, please provide details of what tests are performed on every lot/batch.

9.12Do you have procedures to allow reduced testing of raw materials/products?

If yes, please provide a copy of the reduced testing procedures.

9.13When reduced testing is performed, is it indicated on the certificate of analysis?

9.14Are inspection and testing results for raw materials reviewed by qualified laboratory personnel?

9.15Who has the authority to approve and reject raw materials/products?

9.16Do you retain inspection and testing records for each lot/batch of raw material/products?

If yes, please confirm how long inspection and testing records are retained?

9.17Do you retain retention samples of each lot/batch of raw material/products?

If yes, please confirm how long retention samples are retained.

If multiple lots/batches of raw material/products are sequentially packed and labelled as one lot/batch do you retain samples from each distinct lot/batch of raw material?

9.18Do you retain copies of labels with the lot/batch records?

9.19Do you provide a Certificate of Analysis or Certificate of Conformance for every lot/batch?

10.1How are raw materials and products packaged?

10.2Do you have easily identifiable security seals or tape on each container of raw material and products to ensure tampering can be recognised?

If yes, please supply a sample or picture of the tamper evident seals or tape.

10.3Please provide details of what information is included on printed packaging and labelling?

If multiple lots/batches of raw material or product are sequentially packed and labelled as one lot/batch do you indicate this on printed packaging and labelling?

10.4Do you have procedures for the control, use and reconciliation of printed packaging and labelling?

If yes, please provide a copy of the procedures for the control, use and reconciliation of printed packaging and labelling.

10.5Do you have procedures to verify the accuracy of printed packaging and labelling?

If yes, please provide a copy of the procedures to verify the accuracy of printed packaging and labelling.

10.6Do you have procedures for minimising packaging and labelling errors?

If yes, please provide a copy of the procedures for minimising packaging and labelling errors.

10.7How are raw materials transported to Australia or the next manufacturing site?

Please explain in detail.

10.8Do you undertake any vendor assurance activities on the transport companies used?

10.9Do you have a list of approved transport companies?

10.10Have transport validation trials been conducted on the transportation methods used?

10.11Do you retain the transport records for raw materials?

10.12Do you use refrigerated transport?

If yes, do you monitor temperature?

If yes please provide a copy of the procedures for monitoring temperature and explain how monitoring is performed and reviewed.

10.13Do you document the supply chain?

If yes, please provide details of how the supply chain is documented.

10.14Do you have procedures to ensure that raw materials and products are packaged, stored, handled and transported in such a way as to prevent contamination and damage?

10.15Are pallets used for international transport only subject to heat treatment and stamped in accordance with the International Plant Protection Convention (IPCC) International Standards for Phytosanitary Measures (ISPM) No. 15 Regulation of Wood Packaging Material in International Trade?

10.16Please provide details of what type of heat or chemical treatment pallets used for local storage and transport are subjected to?

11.1Do you use computer controlled operating systems in the following areas?

Area · Validated · Is data storage in compliance with US FDA 21 Part 11 and PICs GMP?

11.2Do you have appropriate security to limit access to computer controlled operating systems?

11.3Do you have a validation master plan?

11.4Do you validate manufacturing processes and process equipment?

If no, please provide details of any validation that is planned to be undertaken on manufacturing processes and process equipment.

11.5Do you validate cleaning processes?

If no, please explain how cleanliness is determined.

11.6Do you validate analytical methods?

If no, please provide details of any validation that is planned to be undertaken on analytical methods.

11.7Do you validate laboratory processes and equipment?

If no, please provide details of any validation that is planned to be undertaken on laboratory processes and laboratory equipment.

11.8Are any of the starting materials used to manufacture the raw material susceptible to microbiological contamination?

If yes, please explain how this is controlled during manufacture.

12.1Do you have procedures for investigating customer complaints?

12.2Do you have a complaints database?

12.3Who is responsible for conducting customer complaint investigations?

12.4Do you provide a response to customer complaints?

12.5Do you document the cause of the complaint and the corrective action taken in the response to the customer?

12.6Do you retain customer complaint documents?

12.7Does management review customer complaints?

12.8Have there been any recalls in the last five years?

If yes, please provide details of any recalls in the last five years.

12.9Do you have procedures for conducting recalls?

12.10Who is responsible for recalls?

12.11Who has the final decision on whether a recall is initiated?

13.1Do you have stability testing data available for raw materials and products?

If yes, would you provide this stability data if requested?

13.2Do you have an ongoing stability testing program?

13.3Are the analytical methods used for stability testing validated and stability indicating?

13.4Do you undertake stability testing on pilot or production lots/batches?

14.1Do you have procedures for the following aspects of laboratory equipment?

14.2Do you keep records of the following maintenance activities for laboratory equipment?

14.3Are calibration standards used traceable to a recognised standard?

14.4Do you record raw data in duplicate workbooks?

14.5Do you undertake trend analysis on analytical results?

14.6Do you have dedicated sampling facilities?

14.7Do you have procedures for managing analytical reagents and primary reference standards?

14.8Do you have procedures for labelling and determining the expiry date of analytical reagents and primary reference standards?

14.9Please indicate what laboratory capabilities you have?

14.10Please indicate what instrumentation capabilities you have?

Sign below — draw with your mouse, or your finger on a phone or tablet.

The date, time and originating IP address are recorded with your signature.