Saturday 14 September 2013

VENDOR QUALIFICATION QUESTIONARY




PART- A

GENERAL INFORMATION
Material Name/
Product Name

Vendor Name

Name of Manufacturer

Address
Vendor
Manufacturing Facility


Telephone Number (s)


Fax Number (s)


E. Mail Address


Contact Person (s)
Name
Telephone Number
E. Mail
a.
Technical matters



b.
Commercial matters



Nature of Business

Tenure in Business

Turn over value for the last two years
Financial Year


Turn Over Value
Turn over


Number of Employees
Office

Factory

Total











Major Products manufactured in the Unit  (annex the list of your products)
:
Yes / No
List of companies to whom you supply (annex the list of your suppliers)
:
Yes / No
List of companies who has audited you and approved your facilities (annex the list)
:
Yes / No
Flow chart of the manufacturing facilities enclosed.
:
Yes / No
What is your lead time (in days) in supplying this material to us?

How do you rate your self on the following attributes
Price
:
Excellent

Good

Fair

Quality
:
Excellent

Good

Fair

Delivery
:
Excellent

Good

Fair

Service
:
Excellent

Good

Fair

Give three of your strong Points:

1.


2.


3.














Questionnaire filled in by

Name __________________________                Position ______________________________

Signature ________________________                Date      ______________________________




PART – B
TECHNICAL INFORMATION
1.0       GENERAL INFORMATION
1.1
Is your company certified according to Quality Standards?
:
Yes / No

If yes, which standard?

1.2
Have any regulatory authorities / government agencies inspected this site within the last two years?
:
Yes / No

If yes, please detail.

If yes, Please provide dates:

If yes, please state which of the products on the “Products involved” list is covered by this standard?

1.3
Is your company in the process of being certified?
:
Yes / No

If yes, when is certification expected?

1.4
By which standard?

1.5
Do you manufacture, handle, store or use any risk material in the same site as:

Antibiotics
:
Yes / No
Cytotoxics
:
Yes / No
Hormones
:
Yes / No
Steroids
:
Yes / No
Vaccines/Sera
:
Yes / No
Biological
:
Yes / No
Pesticides
:
Yes / No
Herbicides
:
Yes / No
Organo phosphorous compounds
:
Yes / No
If yes : Specify the product names







1.6
Is the product produced using the same equipment batch over batch?
:
Yes / No
1.7
Do you possess a Quality Manual?
:
Yes / No









1.8
Is there a program for self-Inspection?
:
Yes / No
1.9
Are Material Safety Data Sheets (MSDS) available for all commercially distributed products?
:
Yes / No
1.10
Can you provide impurities reference standards and degradation products for the material together with their certificate of analysis?
:
Yes / No
1.11
Is the list of all the products manufactured in the site attached?
:
Yes / No
1.12
Is the local authorities GMP certification attached?
:
Yes / No
                                                                                               
2.0.  ORGANISATION AND PERSONNEL  
  
2.1
Is there a quality Control/Assurance Dept. which is responsible for the approval / rejection of all products, raw materials, Intermediate products, containers and labels?
:
Yes / No
2.2
Is there a training program for the employees?
:
Yes / No
2.3
Name the functions responsible for batch release and product Specifications.










                                                         

3.0  FACILITIES

3.1
Are the individual production areas sufficiently separated from each other to prevent cross-contamination and mix-ups?
:
Yes / No
3.2
Is enough room available for equipment and material?
:
Yes / No
3.3
Are there written procedures covering pest control?
:
Yes / No
                                                                                                                                   
4.0   EQUIPMENT

4.1
Are records available on the cleaning, maintenance, repair and inspection of equipment?
:
Yes / No
4.2
Is the equipment calibrated in accordance with the written instructions using certificate-measuring instruments?
:
Yes / No
4.3
Are multipurpose facilities cleaned in accordance with a validated cleaning specification?
:
Yes / No




5.0       CONTROL OF MATERIALS   
5.1
Is there a documenting system for incoming materials (amount, Lot No., Supplier, etc)?
:
Yes / No
5.2
Is each incoming lot given a separate ‘company control/lot number’ and how is this organized? For description, attach separate sheet.
:
Yes / No
5.3
Are all incoming materials placed in quarantine, until they are released for use?
:
Yes / No
5.4
Are products approved for release by the Quality Control Dept.?
:
Yes / No
5.5
Is each lot checked and approved for release by the Quality Control Dept.?
:
Yes / No
5.6
Does sampling take place in a separate area to prevent cross-contamination?
:
Yes / No
5.7
Are materials, which have been queried, blocked and labelled in such a way as to prevent them from being used?
:
Yes / No

6.0   PRODUCTION                                                                                   

6.1
Are there written procedures for the production and the in-process control?
:
Yes / No
6.2
Are any deviations documented in the manufacturing records?
:
Yes / No
6.3
Are there written specifications for the in-process controls?
:
Yes / No
6.4
Are rework and reprocessing procedures approved prior to execution?
:
Yes / No
6.5
Do the Master Formula and the Batch Records contain details about the equipment used?
:
Yes / No
6.6
Have the manufacturing processes been validated?
:
Yes / No
6.7
Are equipment and machinery, once cleaned, protected from contamination (dust, etc.)
:
Yes / No

7.0  SUPERVISION OF PACKING AND LABELING             

7.1
Describe labeling and packaging procedures.



7.2
Are access to and the administration of labels limited?
:
Yes / No
7.3
Are different labels used for each batch/lot and are these carefully checked?
:
Yes / No
7.4
Does repacking take place in a separate area to prevent cross-contamination and mix-up?
:
Yes / No
                        
8.0       LABORATORIES
8.1
Is the equipment used in the laboratory calibrated and documented in accordance with written specifications?
:
Yes / No
8.2
Is each batch/lot of raw material, intermediates and finished goods tested and approved for release in accordance with special written procedures and specifications?
:
Yes / No
8.3
Are products, which do not fulfil specifications rejected, and the reason for the discrepancy documented?
:
Yes / No
8.4
Is the work done in the laboratory documented and can it be traced?
:
Yes / No
8.5
Are reserve samples kept for a specific and documented period of time?
:
Yes / No
8.6
Is there a written stability-testing program? Briefly outline the program.
:
Yes / No







8.7
Do all products bear expiration date?
:
Yes / No
8.8
Are contract laboratories used to perform testing?
:
Yes / No
8.9
Is the laboratory staff provided a structured training program and is there a documented evidence of this training?
:
Yes / No

9.0  QUALITY ASSURANCE                                                                                

9.0
Does the checking of production data include the following Points?

- Identity of the product
:
Yes / No
- Correct packaging
:
Yes / No
- Control of batch records
:
Yes / No
- Notification forms for kind of deviations
:
Yes / No
-  Analytical results
:
Yes / No

10.0     OTHERS:
Text Box: Questionnaire filled by:
Name:…………………………...				Position:…………………………..

Signature…………………………				Date: ……………………………
 





Do not fill in the section, reserved for Aurobindo pharma comments.

COMMENTS:







CONCLUSION:














Quality Assurance

PART -C
 MATERIAL SPECIFIC INFORMATION
Product Name /
Material Name: 

How long you are manufacturing this product?

Is it a continuous or batch process?

What is the minimum batch size?

What is the maximum batch size?

Do you have expiry period for this material? If yes how do arrive it? Please Explain?


Attach the stability details of this material.
:
Yes/No
Category of product (Tick which ever is applicable):

Key raw material / Raw material / Primary packing material / Secondary packing material






Fill the following details for Key raw material / Raw Material

Do you have DMF number?
:
Yes/No
If yes provide details :

Do you use water in the process?
:
Yes/No
If yes, what is the source and quality? What standards does the water quality conform to?

Do you use any Class 1 solvents in the process? Please provide a certificate of disuse, if not used.
Benzene
Yes 
No  
Carbon Tetrachloride
Yes 
No  
1,2 Dichloroethane
Yes 
No  
1,1 Dichloroethene
Yes 
No  
1,1,1 Trichloroethane
Yes 
No  








Do you use any Organic Volatile Impurities (OVI) solvents in the process? If yes specify the limits in the product specifications

Specification
Chloroform
Yes 
No 

1,4 Dioxane
Yes 
No 

Methylene Chloride
Yes 
No 

Trichloroethylene
Yes 
No 

Do you use any Animal Origin Material?
Yes 
No 
If yes, provide TSE risk (Transferable Spongiform Encephalopathies) free certificate.
Have you identified the synthetic impurities/related impurities and degradation products?
:
Yes/No
Are contract laboratories used to carryout testing?
:
Yes/No
If yes please specify the names and address

Specify the packing details
Pack Size (s)     :
Packing Details :

Labeling Details :
(Including shelf life & Storage conditions)

Do you Provide Working Standard and Related Impurities?
:
Yes/No
Safety and Handling precautions (MSDS)?
:
Yes/No
Do you Manufacture any other products using the same equipment?
:
Yes/No
Do you use dedicated/separate equipment for Penicillin / Cephalosporin / Cytotoxin products or intermediates?
:
Yes/No
If the same equipment is used for different product manufacturing do you clean equipment before product changeover?
:
Yes/No
Do you have written cleaning procedures for product changeover?
:
Yes/No










Fill the following details for Key Primary / Secondary Packing materials

Do you have a DMF for this product?
:
Yes/No
If yes, attach letter of Authorization.
:
Yes/No
Attach Food Grade Certificate.
:
Yes/No
Does your product conform to the relevant clauses of the 21 CFR regulations?
:
Yes/No
Provide your test procedures and specifications.
:
Yes/No




DECLARATION
1.      The information provided in the questionnaire is based on scientific evidence.

  1. We inform all the changes in the Manufacturing Process, Specifications and Analytical Procedures prior to the implementation and shall be carried out after your approval.
Questionnaire accomplished by:
Name
Designation
Signature
Date






















                                                                                                    
                                                VENDOR QUALIFICATION INFORMATION
Attach the Following Documents
Annexure - I
List of manufacturing equipments
Yes 
No 
NA 
Annexure – II
List of Testing instruments
Yes 
No 
NA 
Annexure – III
Brief Manufacturing Process
Yes 
No 
NA 
Annexure -IV
Flow chart of manufacturing facility
Yes 
No 
NA 
Annexure – V
Product Specifications
Yes 
No 
NA 
Annexure – VI
Standard Test Procedure
Yes 
No 
NA 
Annexure – VII
List of Synthetic Impurities at each stage of manufacturing
Yes 
No 
NA 
Annexure – VIII
Working standard Profile
Yes 
No 
NA 
Annexure – IX
Characterization data
Yes 
No 
NA 
Annexure – X
Residual Solvent statement
Yes 
No 
NA 
Annexure – XI
Organic Volatile Impurities statement
Yes 
No 
NA 
Annexure – XII
Compliance certificate for 21 CFR
Yes 
No 
NA 
Annexure – XIII
Food grade certification
Yes 
No 
NA 
Annexure – XIV
Material Safety Data Sheet
Yes 
No 
NA 
Annexure – XV
Stability / Holding Time studies
Yes 
No 
NA 
Annexure – XVI
TSE / BSE certificate
Yes 
No 
NA 
Annexure-XVII
List of major customers for the above product
Yes 
No 
NA 
Annexure-XVIII
List of other major products manufactured
Yes 
No 
NA 
Annexure – XIX
List of major companies audited
Yes 
No 
NA 
Annexure – XX
Copies of the certificates such as FDA / TGA / WHO / ISO 14000 / ISO 9000 / other, if any
Yes 
No 
NA 

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