Identification and Information Questionnaire

Pharmaceuticals Manufacturers

Identification and Information Questionnaire

I. Identification

Name of the company:......

Year of establishment:......

Head Office address:......

......

Telephone......

Fax number......

Website......

Trade Register number: ...... VAT number:......

2. Manufacturing sites

List below ALL the company manufacturing sites that you intend to propose for a possible collaboration with the MSF procurement department.

……………………………………………………………………………………………………………………….

For each of them, complete the information below (duplicate if needed):

2.a. General information

Name of the site/unit ......

Location and exact address of the site/unit:......

......

Telephone......

Fax number......

2.b. Type of production(tick the boxes)

Non β lactames

β lactames  Penicillins
 Cephalosporins

 Rifampicin formulations

 Hormones

 Others

------

Active Pharmaceutical Ingredients

Formulations

Oral forms

Tablets

Capsules

Solutions or syrups

Dry powder for suspension

Others (please precise ……………………………………………)

Parenteral forms

Small volume liquid injectables

Dry powders for injection

Large volume parenterals

Others (please precise ………………………………………………)

Others

Creams and ointments

Suppositories

Vaginal tablets

Ophtalmic preparations

Solutions or emulsions for external use

Others (please precise …………………………………………..)

2.c. Regulatory status

License number(s): ...... (attach a photocopy)

GMP certification

Is your manufacturing site regularly inspected by your National Drug Regulatory Authorities (NDRA's) towards the WHO GMP ?

Yes

If no, please provide the exact reference of the GMP used by the NDRA’s (and version)

……………………………………………………………………………………..

Date of the last NDRA inspection ...... (Attach a copy of your GMP certificate)

Other recent GMP inspections

Has this manufacturing site been recently (over the last 2 years) inspected by a PICs member inspectorate, by the US FDA or by the WHO Pre-Qualification Geneva inspectors

Yes

PICs inspectorate (date of inspection + name of authority) ......

WHO PQ inspection (date) ......

US FDA inspection (date) ......

Would you accept to forward a copy of the inspection report to MSF ?

Yes (please attach a copy)

Has this site been recently (over the last 2 years) inspected by any other National Drug Authority

Yes Which Drug Authority ......

Date ......

Has this site been recently (over the last 2 years) inspected by the UNICEF Supply Division (Copenhagen) inspectors

Yes (date) ......

Would you accept to forward a copy of the inspection report to MSF ?

Yes (please attach a copy)

2.d. Site Master File

Please attach a copy of your SMF to the questionnaire.

NB : If a computer copy of the SMF is not available, you can post a paper copy of it to one of the following addresses (tick the case in front of the address and precise the date of shipment and name of the transporter (DHL, ...)

MSF International officeShipment date ......
Rue Saint SabinTransporter ......
75011 Paris

France

MSF Logistique Shipment date ......
Avenue de l’Argonne, 14 Transporter ......
33700 Mérignac

France

MSF Supply Shipment date ......
Preenakker, 20 Transporter ......
1785 Merchtem

Belgium

2.e. Affiliates

Do you carry manufacturing activities on behalf of other companies in this particular location ?

Yes

Name of the parent company (ies):

……………………………………………………………………………………..

Do you sub-contract part of your activities to another company ?

Yes

Name of the subsidiary company per type of activity:

……………………………………………………………………………………..

2.f. Marketing and registrations

Do you register and market your products

for domestic market

for export

Are you able to provide MSF with an updated list of products per countries of registration ?

Yes (If yes, attach the list to the questionnaire)

Are you able to provide a certificate of pharmaceutical product according to the WHO Certification Scheme on the Quality of Pharmaceutical Products moving in International Commerce for all your products ?

Yes

If yes, please attach a copy of one recent certificate as an example

If no, explain why ………………………………………………………………………………………………….

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

2.g. Staff

Number of employees:

Number of pharmacists:

Attach an organization chart to the questionnaire

2.h. Turnover for the last 3 years

year : ...... Turnover :......

2.i. Representative clients

Mention some representative clients on domestic market and on export market (precise the profile of the client: NGO, non profit, public health facilities, private business...)

NameTypeClient since ?

......

2.j. Commercial contact

Name of the export manager:......

Phone:......

Fax:

2.k. Key positions

Quality Assurance Manager

Name………………………………………………………………………………………………………………...

Qualification ……………………………………………………………………………………………………...

Head of Quality Control Department

Name………………………………………………………………………………………………………………...

Qualification ……………………………………………………………………………………………………...

Head of Production Department

Name………………………………………………………………………………………………………………...

Qualification ……………………………………………………………………………………………………...

III. Commitment

I undersigned,

Mr/Ms ...... General Manager,

certify that information provided in this questionnaire is correct.

Date:......

Signature

MSF MIF version May 2007