LOC Pharma. Anlage. Lieferantenfragebogen Supplier Questionnaire. 9. Is the warehouse temperature controlled or air-conditioned?

Transkript

1 Please complete this questionnaire and return to: z.h. Leiter Qualitätsmanagement Name and position of person completing the questionnaire Signature Date 1. Name of Company 2. Address 3. Telephone number 4. Fax number 5. Responsible Person (Name & ) 6. Quality Control (Name & ) 7. Customer services (Name & ) 8. Please indicate the type of activities performed at your facility Manufacturing Wholesale Repackaging Distribution 9. Is the warehouse temperature controlled or air-conditioned? 10. Is your facility dedicated for medical devices? 11. Is your facility dedicated for pharmaceutical products? 12. Do you trade with narcotics? 13. Do you have temperature monitoring equipment?

2 14. Do you record humidity? 15. Is your temperature monitoring equipment calibrated? 16. How long do you keep temperature/humidity documentation? 17. Do you have ISO 9000ff or ISO accreditation? 18. Do you have an alarmed Monitoring System? 19. If yes, please attach copy of the certificate. Attached 20. Does your company conform to a recognized code of practice as a pharmaceutical supplier? 21. If yes, please attach copy of certificate or code of practice. Attached 22. Does your company have a Quality Manual? 23. Does your company work to Standard Operating Procedures? 24. If yes, please attach copy of the index Attached 25. Do you carry out self-inspections of your facility? Yes (5) Informal (3) No (1) 26. Has any Health Authority or Regulatory Organization inspected your facility within the past 24 months? 27. What was the result of this inspection? 28. Does your company hold a current Wholesale Dealer s License, Manufacturer s License or equivalent license? 29. Please attach a copy of them. Attached 30. Do you maintain an approved suppliers list? 31. Do you audit your suppliers? Yes (5) Informal (3) No (1)

3 32. Is your facility inspected for pests? Yes (5) Informal (3) No (1) 33. Please provide a copy of your last pest control report Attached 34. Do you have SOP for cleaning and keep cleaning records? Yes (5) Informal (3) No (1) 35. Are all products supplied from EU origin? 36. How do you ensure that all product are from EU origin? 37. Do you have clearly designated approved, quarantined and rejected areas? 38. Are products checked for counterfeit? 39. How do you check your goods to avoid counterfeit products? 40. How do you avoid buying counterfeit products? 41. Do you operate a stock-location-system? 42. Do you operate a quarantine-system? 43. Is there a verified GMP training for the staff? Yes (5) Informal (3) No (1) 44. Do you have a formal complaints procedure? Yes (5) Informal (3) No (1) 45. Do you analyze your customer complaints? Yes (5) Informal (3) No (1) 46. Do you have an emergency plan (SOP) for product-recall? 47. Will you allow or its agents to perform a quality inspection of your facility?

4 Additional Questions / Statements

5 EVALUATION Supplier Questionnaire of on: QUESTIONNAIRE EVALUATION (TO BE COMPLETED BY LOC PHARMA) Total Scale Rating (Total Points Questions 1 47): Total Scale Rating: : Acceptable: : Acceptable - Establish Monitoring Plan: 83-29: Not Acceptable: This Supplier Questionnaire was reviewed and responses are: Acceptable Not Acceptable Comments: Name: Signed: Date: FOR INTERNAL USE ONLY Documents checked and approved by Head of QM-Dept. (QMB) Signed: Date: