VENDOR ASSESSMENT CUM REGISTRATION (VAR) FORM: MATERIALS

 

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Fill in the required information of attach document wherever applicable.

General INFORMATION
Name of Organization
Address, email and website
Name & Address of contact person with Telephone No and email (Technical Matters)
Name & Address of contact person with Telephone No and email (Commercial Matters)
Name & Address of contact person with Telephone No and email (Quality Assurance)
Address of Manufacturing Location
Name and Address of other manufacturers involved in production process
Month and year of establishment
Annex the list of Key Products (State whether  Manufacturer/ stockiest/ dealer)
Total manufacturing site area
Total Constructed area
Do you have separate production facilities for each of your product? If so, what is the total capacity
FINANCIAL AND COMMERCIAL INFORMATION
Any material being / previously supplied to the company
Attach techno commercial offer for the products in question
Sales tax or other information of compliance nature
Name of key customers
Presence in Low Cost Countries (Emerging markets)
Give your total production capacity for the product in question and annual sales volume
Please give major buyer-wise percentage (Attach separate sheet, if required)
What was the annual turnover of your company during last financial year?
What is the lead-time for delivery of the products?
Is a third party involved in supply logistics? If yes give details.
TECHNICAL AND QUALITY
Mention your Manufacturing License No./ Registration No. with date of issue
Is your company ISO certified? If yes please specify the year and certification body & type of certification
Have your manufacturing facility been inspected by WHO etc? if yes please provide the copy of WHO certificate?
Please provide list of the products which are filed with USFDA or EDQM (If any).
Please mention specifically awards won by your company
Quality award           Service award           Safety award           Any other award
Any other details which you would like to state for consideration in placing your company on our approved vendor list
Have your facility been inspected by any regulatory body within last 2 years if yes please give the name of agency, date & status of audit?
Do you inform us about the changes in your contact address & contact person?
Would your company willing to allow one of our auditors to audit you Quality System.
Do you inform us about the changes in your manufacturing facility and manufacturing process including change in the vendor of your input material?
Number of Employees
Production	QA/QC	R&D	Others	Total
Whether Quality Unit is independent from the manufacturing department. Annex the Organogram?
Attach qualification and experience record of key and approved personnel       (Attach List)
Does your company perform periodic medical check-up of all the employees?
Does your company have annual training plan for the personnel?
Name of the key raw materials used  (Attach separate sheet, if required)
Do you have the written instruction and policies to implement Quality System? If yes please annex the list of written instructions and polices.
Does the quality system include change control, deviation control, document control, self-inspection & vendor qualification policy?
Do you have written validation policy? If yes please annex the table of contents of validation master plan.
Do you have the written calibration program for measuring & testing instruments?
Do you have the written preventive maintenance program for equipments?
Do you have document storage and retrieval policy?
Are there physically segregated areas for raw and packaging materials
Are there separate areas for materials requiring special storage conditions controlled temperature & humidity
Does your material issuance policy consider the FIFO?
Attach process flow diagram for the manufacturing operations
Attach list of equipments in manufacturing and quality control
Is production line dedicated for one product? If not, give details of product changeover procedure.
Does man and material movement is adequate to prevent the mix – ups?
Are there any in-process checks in the manufacturing process
Are the manufacturing processes validated?
Do you manufacture penicillin or cytotoxic drug in dedicated facility with all containment controls of material, personnel and equipment?
Does the equipment cleaning procedures are validated?
Do you have In-house testing facility of raw materials used in the manufacture of drugs (If yes, give details of the test).
Do you have specification for all packing/packaging material
Is there a documented procedure for reprocessing (if any)
Is there a procedure for destruction of printed packaging Material
Is there a procedure for return of unused material to stores
Are the environmental conditions of finished goods storage area controlled w.r.t. temperature and humidity
Do you maintain the reserve samples?
Who performs the quality control functions (Designation)
Do you have an Internal Audit System
Are you open to initial inspection and thereafter periodic visits by our designated team
Are you willing to notify any critical changes related to product process and equipment
Are you willing to replace rejected material, conditions if any.
PRODUCT SPECIFIC INFORMATION
Please furnish the following document related to the product of interest
Material release specification
Standard test procedure
Material Safety Data Sheet
Drawing & Material of construction (MOC) certificate for packing material
Stability data
Process flow chart
Packing details
Storage Conditions
Handling Precautions
Mode of dispatch
Any sample sent along with the form:
Sample Details (Number, pack size, packing details, mode of dispatch)

Authorized Signatory   Signature    : ____________________        Name   :    _____________________________   Designation  :___________________        Date   :    _____________________________