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:

 

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. 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  □