PIRAMAL PHARMA LIMITED

Quality Assurance

Vendor assessment Checklist

Annexure 02 VENDOR PROFILE – RAW MATERIAL

(Information to be provided by Vendor)

Material Name(s) proposed to be supplied to PPL :

(i) (ii)

1. Name of the company

2. Company Profile Attached SMF  /Additional information 

3. Website

4. Year of establishment

5. Status of your company Proprietary  / Partnership  / Private Limited  /

Public Limited  / Other  …………………………..

6. Board of Directors i)
ii)
7. Items manufactured

8. Annual Turnover for the previous

three years

9. Drug License No.

(Please attach copy if applicable)

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Quality Assurance

Vendor assessment Checklist

10. Office Addresses

Tel. No.:

Contact Person Tel. No.:

Out of Hrs. Tel. Nos.

Fax

E-mail

11. No of Manufacturing units

Address for the Site of Manufacture:

[For the item(s) proposed]

Tel. No.:

Contact Person Tel. No.:

Out of Hrs. Tel. Nos.

Fax

E-mail

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 PIRAMAL PHARMA LIMITED
Quality Assurance

Vendor assessment Checklist

12. Major Clients

13. Countries of Exports

14. Personnel strength / Number of employees in:

Production area

Quality Control

Research and Development

Quality Assurance
15. Have you been audited and approved for GMP WHO-GMP , MCC , TGA , MHRA ,
by National / International authority? USFDA , ISO , Other 
………………………………………..

Date of the latest audit & Name of authority

Are you willing to provide us with copies of Yes  / No  / Not Applicable 

Certification

16. Can you provide an official GMP certificate for Yes  / No  / Not Applicable 
the product(s)?

17. Is the site a mono production site? Yes  / No 

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 PIRAMAL PHARMA LIMITED
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18. Name of API’s, manufactured in the same

manufacturing area.

19. Do you have dedicated facility for following in case you are manufacturing the same?
Production of hormones/steroids Yes  / No  / Not Applicable 

Production of Beta– Lactam / Cephalosporin Yes  / No  / Not Applicable 

antibiotics
Production of material which are derived from Yes  / No  / Not Applicable 
animal source
20. Is there any highly effective substances and toxic materials:
Production Yes  / No 
Packaging Yes  / No 
Storage Yes  / No 
Transport Yes  / No 
21. Is the manufacturing process for the products Yes  / No 
proposed for offering have been validated?
22. Can you provide following documents as a part of Tech Pack:
4.1.1 Process Flow Chart  / Route of Yes  / No  / Not Applicable 
Synthesis  / Method of analysis 
Impurity Profile along with chromatograms  / Yes  / No  / Not Applicable 
Trend data Tabulation 
Trend Data on Residual solvents  / Organic Yes  / No  / Not Applicable 
Volatile Impurities (OVI) 
Trend data on Microbial Profile (As applicable) Yes  / No  / Not Applicable 
Long term  & Accelerated stability data as per Yes  / No  / Not Applicable 
ICH 
Particle size Distribution  / Bulk Density  / Sieve Yes  / No  / Not Applicable 
Analysis 

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 PIRAMAL PHARMA LIMITED
Quality Assurance

Vendor assessment Checklist

Open part of DMF  / COS Ref. copy  Yes  / No  / Not Applicable 

(For regulatory market)
5.1.1 Working Standards for API
Working Standards for Impurities  and Related
Substances  as applicable
TSE  / BSE  / GMO  certificates (as applicable)
Information on standard pack
Material Safety Data Sheet
23. Do you agree to on-site audit?
Yes  / No  / Not Applicable 
Yes  / No  / Not Applicable 
Yes  / No  / Not Applicable 
Yes  / No  / Not Applicable 
Yes  / No  / Not Applicable 
Yes  / No 

24. Are you willing to inform us prior to the implement major changes in:
Site of Manufacture Yes  / No 
Major production equipment Yes  / No 
Change in the process of manufacture Yes  / No 
Technology Yes  / No 
Quality specification Yes  / No 
Test methods Yes  / No 

Note: Kindly provide all relevant documents against which site has marked availability remarks
as “Yes” and provide justification for which site has marked “No/ Not applicable”.

Suresh Parihar ________________________________

Manager – CPD Quality Assurance Name and Designation of Site Personnel
(Sign & Date)

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