Vendors Evaluation Form in Pharmaceuticals

Standard Operating Procedure of Vendors Evaluation Form in Pharmaceuticals is describe in this post.

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1.0 INSTRUCTIONS

1.1 All questions should be answered.

1.1.1 Tick “√” in appropriate spaces for “Yes”. “No”, “Plan” or “N/A”

1.2 Answers should reflect the current status. Do not reflect procedures or capabilities which are anticipated or proposed.

1.3 Evaluation form should be returned within ten (10) to fifteen (15) days.

1.4 Submit this Evaluation form to the ___________ Pharma.

1.5 Qualified person or the head of the department for quality assurance should supervise the completion of this questionnaire and confirm the correctness of all the statements with his / her signature and stamp.

1.6 Please supply us with additional information or comments on a separate sheet of paper, if applicable.

1.7 When returning this questionnaire, please include company’s Site Master File, brochure and a list of your products.

1.8 Please return the completed questionnaire to the below mentioned contact person at Pharmaceuticals

1.8.1 Name & Position:_____________________________________

1.8.2 Phone Number:______________________________________

1.8.3 Fax Number:__________________________________________

1.8.4 Email Address:________________________________________

1.8.5 Postal Address:________________________________________

1.9 Certified that the information provided is complete and accurate.

1.9.1 Vendor (Manufacturer) Signature (Authorized Official)

1.9.2 Title _________________________________________________

1.9.3 Date_________________________________________________

2.0 INFORMATION ABOUT MATERIAL:

2.1 For Raw Material:

2.1.1 Active Raw Material

2.1.2 In-Active Raw Material

2.2 For Packaging Material:

2.2.1 Primary Packaging Material

2.2.2 Secondary Packaging Material

2.2.3 Tertiary Packaging Material

2.3 For Aiding Accessories:

2.3.1 Machine

2.3.2 Tools

2.3.3 Electronics

2.4 Name of Material:

2.5 Material Code:

2.6 Ref:

2.7 Other companies you supply to:

3.0 INFORMATION ABOUT VENDOR (MANUFACTURER):-

3.1 Name of Vendor (Manufacturer):

________________________________________________________________

3.2 Address:

________________________________________________________________

_______________________________________________________________

3.3 Telephone/fax/e-mail:

3.4 Contact Persons:-

Designation	Name	Qualification	Extension
1.
2.
3.

4.0 BRANCHES IF ANY OF VENDOR (MANUFACTURER):-

4.1 Address:

________________________________________________________________

4.2 Telephone/fax/e-mail:

________________________________________________________________

4.3 Contact Persons:-

Designation	Name	Qualification	Extension
1.
2.
3.

5.0 SISTER CONCERNS IF ANY OF VENDOR (MANUFACTURER):-

5.1 Address:

________________________________________________________________

5.2 Telephone/fax/e-mail:

________________________________________________________________

5.3 Contact Persons:-

Designation	Name	Qualification	Extension
1.
2.
3.

6.0 Requirement:-

Questions		Yes	No	Plan	N/A
1. Is your company the subsidiary of another company or corporation?
2. If yes, please state name of parent company:
3. How long has company been in business as presently organized?
4. Number of local employees Total:
Production:
Quality Control:
Quality Assurance:
Sales:
5. Approx. area of your site (m2) Inc.
6. How many Hours and number of shifts your staff work? (8×3), (12×2)
7. Products manufactured on site?




8. Do you produce sterile products?
9. Do you produce or handle highly potent, toxic or sensitizing drugs (e.g. antibiotics, hormones or cytostatic)?
10. Do you offer any additional services? (enclose a description, if applicable)
11. Do you manufacture the same API at more than one site and if so, is it possible to determine at which site production took place?
12. Do you receive materials from different manufacturing sites and if so, is it possible to determine at which site production took place?
13. Are procedures implemented to follow the requirements according to ICH Q7A or EU GMP Guide Part 2?
14.	Is your company certified according to
	GMP (if yes, please enclose certificate)
	ISO 9001 or equivalent (if yes, please enclose certificate)
	ISO 14000 and/or EU Regulation on Environmental Audit (if yes, please enclose certificate)
15. Is it possible to trace every batch of any product back to the manufacturer?
16. Will you inform us, in advance and on your own initiative, if you select a different manufacturer for a certain product (as mentioned in your change control procedure)?
17. Do you agree to supply your products with a certificate of analysis per batch?
18. Do you have change control protocols?
19. Do you have a program to audit your company?
20. Do you assess your manufacturers / suppliers?
21. Do you have a program in place to audit your manufacturers?
22. Will you supply Drug Master Files (open part) on demand?
23. Will you supply Manuals on demand?
24. Will you supply TSE/BSE Certificate on demand?
25. Are safety data sheets available (MSDS)?
26. Do you sample incoming goods chemicals for manufacturing?
27. Do you store the products under controlled and stable conditions?
28. Do you have a pest control system in place?
29. Do you have per year turn over?
30. List principal companies and/or Government agencies which have surveyed and approved our Quality Control system: