Lakeshore Hospital and research centre limited

PREQUALIFICATION OF SUPPLIERS FOR NEGOTITAION OF ONCOLOGY & GENERAL DRUGS

Applicants for prequalification need to fill out one form for part I-III. However, Part IV requires that separate forms be filled out for each product being offered for prequalification.

Information provided by potential suppliers seeking prequalification must be regarded as confidential information.

I. BUSINESS INFORMATION

Name of the company:
Year established:
Form of the company: Individual
Partnership:
Corporation:
Other (specify):
Legal Status:
Trade register number:
GST Number :
License Number (attach copy) :

Address:
Telephone:
Email:

Type of activity carried out by the company

	Manufacturer		Wholesaler
	Branded products		Branded products
	Generic products		Generic products
	Medical supplies		Medical supplies
	Laboratory reagents		Laboratory reagents
	Other products (specify below)		Other products (specify below)

Indicate % of annual turnover:
Pharmaceutical formulations: %
Bulk drugs: %
Medical Supplies: %
Products manufactured for export Sold only to the local market Both :

Annual sales turnover in the previous three years. Split export and domestic sales.

Annual turnover	Domestic sales	Exports	Year

II. MANUFACTURING INFORMATION

Total number of________________________drugs manufactured (provide list of manufactured products).
Does your company have GMP certification?: Yes
Certified by: No

Indicate if your company has other types of certification

ISO Type of ISO certification:
WHO Certification Scheme:
Others (specify) :

Attach Certificates of Good Manufacturing Practices (GMP), ISO or Certificates of Pharmaceutical products according to WHO .Certification Scheme covering each item you propose to export

Does Government carry out inspections and controls on the production of drugs in your company?:

Yes

If “Yes”, give date of last inspection:
Date, number and expiry date of current business licence or permit. :
Date:
Number :
Expiry Date :

Date, number and expiry date of current business licence or permit. :
Date:
Number :
Expiry Date :

Do other companies package any of the products you manufacture? :

Yes

If any products are repackaged, attach a list of such products with the name and address of the manufacturer for each product.

Provide detailed information on the quality assurance procedures followed.

II. QUALITY INFORMATION

Do other companies package any of the products you manufacture? :

Yes

Are all raw materials completely tested prior to use or is a Certificate of Analysis accepted? :

Yes

Are control samples of each batch retained? :

Yes

Do you have written cleaning procedures? :

Yes

Do you have written recall procedure? :

Yes

Are all quality control tests performed internally? :

If “No,” tests performed by external laboratories

Tests	Laboratories	Address

Do you keep samples of each batch? :

Yes

Indicate how long do you keep the samples:_________________________________________years

Attach a detailed account of the current quality assurance system in your company. A Quality Assurance manual or handbook may be submitted.
Describe your storage facilities:

IV. PRODUCT INFORMATION

Active Pharmaceutical Ingredient(s)
Trade Name of the product :

Dosage form: Tablets Capsules Ampoules Vial Others (specify)

Strength of the dosage unit

Route of administration Oral IM IV SC Others (specify)

Please note the last date of submission of prequalification form

CERTIFICATION

I, the undersigned (full name of the person responsible)

Name:

Designation:

Hereby declare that all the information given above is true, and I take the full responsibility for

all consequences that might arise from false or erroneous information.

If required, I will cooperate with any official of VPS LAKESHORE HOSPITAL & RESEARCH CENTRE LTD. in making personal inspection of manufacturing facilities and records.

Name:

Designation:

Signature:

Date: