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					Auditing Guide

Appendix B – Customer Questionnaire

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Preamble It is the purpose of this questionnaire to facilitate the preparation of the auditors for the audit at your company and to make it as efficient as possible. It is neither intended for self-assessment nor for vendor rating or qualification. Every information provided in this questionnaire will be treated strictly confidential. Nevertheless it is acceptable if your company concludes not to answer some of the questions listed below. In case your company agrees to submit some/all of the requested documents these will be transferred back to your company by the auditors at the time of the audit.

1. 2. 3. 4. 5. 6. 7. 8.

General Information about the Company
Company name Address of Company Name of production plant to be audited and address if different from no. 2 Telephone (Switchboard) and Fax number where the audit takes place Name of product(s) subject to the audit Approximate size of the plant Approximate number of employees Is this a pure production site or are there other Headquarters functions (e.g. Research) located? Which Headquarters functions are going to be audited in the scope of this audit? Are there other Divisions of the company located at the production site? Are there other companies located on the same area as the company to be audited? If so, which companies are these?

9. 10. 11. 12.


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14. 15. 16. 17.

Is the plant to be audited a pure API manufacturing site or does it also manufacture medicinal (drug) products? Does your company have an Internet address? If so, please specify: Is there other information about your company the auditors could use for their preparation? Name of the “audit representative” of the company for the audit (contact person) E-mail address and telephone number of the contact person

1. 2. 3. 4. 5. 6. 7. 8.

Quality related Information
Is there a Quality Policy in place? Is there a commitment of the management to comply with GMP (ICH Q7a)? Does the company/plant maintain a Quality Management System (e.g. ISO 9000:2000)? Is the company/plant certified according to the Quality Management System standard? How is the Quality Unit (QU) organised? Please provide the names authorised to release APIs and Intermediates to be sold Does your company conduct regular internal audits? Would your company accept to share the internal audit reports with our auditors? Do you have a CEP for the product(s) to be audited? If so, would you provide us with a copy for each product? Do you have a DMF (US) or EDMF (EU)? If so, could you provide a copy?




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11. 12. 13. 14. 15. 16. 17.

18. 19. 20. 21. 22. 23. 24.

Do you have a Site Master File (SMF EU nomenclature; old DMF Type 1 US nomenclature) that you could provide us? How was your API Starting Material been defined? Are you able to provide a rationale for it? Has it been agreed with your local authorities? Would you provide us your latest Product Quality Review for the product(s) to be audited? Can you provide us with a specimen of a certificate of analysis? Are the laboratories used on site or are contract laboratories used? Do you use contract manufacturers for the product(s) to e audited? If so, which steps are concerned? Name and address of the contract manufacturers………… Did your company employ consultants within the past 24 months? If so, please provide name and address Does your company receive materials from agents, brokers, traders etc.? If so, which materials? If so, please specify name and address of the broker/trader


Product related Information
Is the API(s) to be audited manufactured by chemical processing or is it a biotechnological product? Would you please provide us with a brief description of the rout of the synthesis? Are the APIs stored at the facilities to be audited?


2. 3.


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4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

Are they stored else where? Please provide name and address…. Is the facility of the audited product(s) a dedicated or multipurpose plant? Is the API to be audited regarded as high potency or toxic? If so, could your company provide relevant (safety) data? Is a set of current drawings (P & ID) available? Are computer systems used to control production? Are ERES (electronic records and electronic signatures) utilised? Are LIMS systems in the laboratories used? Are microbiological aspects / specifications relevant? Is all GMP related documentation easily retrievable?

1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

GMP related Information
Is there a recall procedure in place? Is there a procedure for handling of complaints? Is there a Change Control System in place? Are critical process steps validated? Is a batch record review conducted? Are procedures in place to handle deviations / investigations? Does an OOS procedure exist? Are OOS batches blended? Has the impurity profile of the API been established? Are stability programmes conducted? Are programmes for calibration of instruments in place?


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12. 13.



Are the employees regularly trained and is the training documented? Is the exposed API protected against contamination? If applicable, are dedicated production areas for highly sensitising materials (penicillins and/or cephalosporins) available? Are APIs (and IM) distributed under quarantine?

E. Comments from your Company
Please provide any additional information your company feels the auditors should be aware of before the audit:


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F. Requested Documents
For the propper preparation of the auditors we ask you to provide th following documents. This has to be seen as a purely voluntary action of your company after deciding wether or not it is feasible to submitt such sensitive documentation to the auditors. It is totally acceptable if your company has decided to refuse to provide some or all documents listed below. We guarantee your company that the sumitted documents will be treated strictly confidential. All documents will be returned after the audit has been completed. 1. Information about the company 2. CEP(s) 3. EDMF(s) 4. DMF(s) (US) 5. Specimen of a Certificate of Analysis 6. Example of an Product Quality Review 7. Site Master File 8. Description of synthesis 9. Data in case of high potency product


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