PHARMACEUTICAL PRODUCT QUESTIONNAIRE

Global Drug Facility (GDF)

I. Product identification
Active Pharmaceutical Ingredient(s) (use INN if any):
…………..………………………………………………………………………………………………

Generic name of the product:

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

Trade name (if any): ……………………………………………………………………………………

Dosage form:
Tablets
Capsules
Injectable
Syrups/oral liquids

Other:

Strength per dosage unit:

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

Route of administration:
Oral
I.M.
I.V.
S.C.
Other

Pack size and description of primary packaging materials (including container/closure system and details of materials
composition):
…………………………………………………………………………….……………………………………….
Pack size and description of secondary packaging materials (including container/closure system and details of
materials composition):
………………………………………………………………………….………………………………………….

For parenteral products, all components which may be in contact with the product comply with requirements specified
by BP, EP,USP?
Yes
No

II. Manufacturer of the product

Name, address and activities of the manufacturer and manufacturing site(s) (or contract manufacturer(s)) where any
aspect of the product manufacturer occurs:

Name Physical address Telephone number, Activity (e.g. packaging)

Facsimile number
and e mail contact
details

All sites listed above are licensed by the relevant National Drug Regulatory Authority to perform the activity?

Yes
No

GDF / Pharmaceutical Product Questionnaire / September 2008 Page 1 of 6

The manufacturing sites have been assessed by the WHO Pre-Qualification Program in Geneva, by a Stringent
National Drug Regulatory Authority (SNDRA) and/or any International Procurement Agency (IPA) and found
WHO/SNDRA GMP compliant?

Yes WHO
Yes SNDRA
Yes IPA
No

Name and country of the SNDRA: ………………………………………………………………………

Name of IPA: …………………………………………………………………………………………….
Date of approval: …………………………………………………………………………………………

Please attach a copy of the GMP Compliance notification

This product is pre-qualified by the World Health Organization Pre-Qualification program (WHO PQ).

Yes
No
Submitted
Dossier in preparation for submission

If yes, please indicate WHO prequalification reference number: ………………………………………………………

If dossier in preparation, please indicate tentative date of submission: ……………………………………………….

III. Supplier identification (to be filled in if not identical to that indicated in question II)
Name………………………………………………………………………………………………….…………………...
Address: ……………………………………………………………………………………………….…………………..
…………………………………………………………………………………………………………..…….…………...
Telephone number:……………………………………………………………………………………….….…………….
Facsimile
number:…………………………………………………………………………………………………………
E mail contact details:……………………………………………………………………………………….….…………

Link with the product:
Marketing licence holder
Distributor

Manufacturer
Other….…………………………………...

IV. Regulatory situation (licensing status) in the country of manufacture

Product registered and currently marketed licence n°……………………………………………....

Product registered for marketing in the country of manufacturing but not currently marketed

licence n°……………………………………………….

Product registered for export only licence n°……………………………………………….

Product not registered (please clarify):………………………………………………………………………….

Please attach a Certificate of Pharmaceutical Product (CPP) according to the WHO Certification Scheme
(WHO Technical Report Series No. 863. Earlier version is not acceptable).

If CPP cannot be obtained from the National Drug Regulatory (NDR), please state the reason and send equivalent
document if any:

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

GDF / Pharmaceutical Product Questionnaire / September 2008 Page 2 of 6

V. Regulatory situation (licensing status) in other countries
List other countries where the product is registered and is currently marketed (+ registration number and validity
period)

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

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

VI. Finished product (FP) specifications

BP Edition ………….…
USP Edition………
International Pharmacopoeia Edition

Other …………………………………………………………………………………………………………………...

Please attach a copy of the internal finished product specifications.

Additional specifications to those in the pharmacopoeia (e.g. dissolution, syringeability):

……………………………………………………………………………………………………………………………..
Attach a copy of the model certificate of analysis for batch release.

If specifications are in house specifications, different from BP, USP and Int Ph, attach also analytical method and its
validation.

The manufacturing method for each standard batch size has been validated?
Yes
No

List quantities of the standard batch size: ………………………………

If the product is sterile, please provide details of sterilization processes and/or aseptic procedures used: ……………..
……………………………………………………………………………………………………………………………..

Brief narrative description of the manufacturing process (indicating if there is any new process/technology /packing
operation).

Provide qualitative and quantitative product formula per unit.

Are excipients described in BP, USP or IntPh?: ………………………………………………………………………

If colours and flavourants are used, are these permitted by the EU or USFDA?
Yes
No

State and justify any overages.

VII. Stability
Stability testing data available:
Yes
No

If yes, type and conditions of testing:

• Satisfactory accelerated testing:

Type and material of container:
Conditions (Temperature/Relative Humidity/Duration):
Number of batches:
Batch sizes:
Date of beginning of the study:

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 • Satisfactory real time testing:
Type and material of container:
Conditions (Temperature/Relative Humidity/Duration):
Number of batches:
Batch sizes:
Date of beginning of the study:

Please provide stability data accordingly with the product questionnaire.

Was the stability testing done on a product of the same formula, manufactured on the same site and packed in the
same packaging material as the product that will be supplied?

Yes
No

If no, describe differences: ……………………………………………..

Is on-going stability data available for this product?
Yes
No

If yes please share status report. If no, please indicate your plans for a study.
……………………………………………………………………………………………………………………………

VIII. Label and insert information

Shelf-life:
2 years
3 years
4 years
5 years other……………...

Transport and storage conditions (e.g. «Do not store above 30°C - Protect from light»):
……………………………………………………………………………………………………………………………..
………………………………………………………………………………………………………………………….….

Label language (please attach a copy):
Bilingual English/French
English
French

Other:………………….

Package insert:
Yes (attach a copy)
No

IX. Samples

Please provide a sample with this Product Questionnaire conforming to the product offered.

Please attach a Certificate of Analysis

NB: If you are not able to provide a Certificate of Analysis, please explain.
……………………………………………………………………………………………………………………………

X. Therapeutic equivalence
1.)
demonstrated
a.)
by in vivo bioequivalence studies Reference product:.……………………………………………..
Number of volunteers: …………….. CRO Name and country of study:
………………………………………………..
Performed year:……………………. Bio batch size: ………………………………………………….
Bio batch API(s) source(s):…………

b.)
by another method claimed by the supplier/manufacturer (please describe briefly):

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

c.)
by comparative in vitro dissolution tests

GDF / Pharmaceutical Product Questionnaire / September 2008 Page 4 of 6
 Reference product: .…………………………………………….
According to conditions described in WHO BCS classification document (WHO Technical Report Series
N°937)
Yes
No

d.)
by in vitro dissolution tests

2.)
not demonstrated

3.)
not relevant, please explain why:

Provide a copy of the report of the proof of therapeutic equivalence (BE study, comparative dissolution profile,
dissolution tests, other…).

The product used in the trial or test is essentially the same as the one that will be supplied (same materials from the
same suppliers, same formula, and same manufacturing method).

Yes
No
If no, please explain what the differences are: ……………………………………………………..

XI. Active Pharmaceutical Ingredients(s) (APIs)

(In case more than one active ingredient is used, please replicate this question)

Manufacturer (name, physical address + country):

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

GMP certified:
Yes (attach a copy of the GMP certificate if any)
No
Unknown ………….
Certified by:
……………………………………………………………….………………...

Specifications and standard test methods exist for this API
Yes
No

API used (in INN if any): …………………………………………………………………………………………….

has a Certificate of suitability to the European Pharmacopoeia (CEP)

Certificate: N°: ………………………………………………………………….…………………

The CEP is in possession of the finished product manufacturer (including annex if any)
(Please attach a copy of the CEP).

has a Drug Master File (DMF)

registered in: …………………………………(country) …………………………………………

The full or open part of the DMF is in possession of the finished product manufacturer

has a Technical File
Yes
No

API specifications:

BP
USP
EP
International Pharmacopoeia

Other (e.g. “in-house”; specify:…………………………)

No Pharmacopoeia monograph exists*

Attach a copy of the API(s ) internal specifications

*If there is no monograph in a recognized Pharmacopoeia, then analytical methods should be provided in
addition to In House specifications.

Provide a copy of the Certificate of Analysis of the API from the API manufacturer as well as from the FP
manufacturer.
GDF / Pharmaceutical Product Questionnaire / September 2008 Page 5 of 6
XII. Commitment
I, the undersigned, ………………………………………………….…………………………………………………….,

……………………………………………………………………………………………( position in the company, e.g.

General Manager, Authorised Person, Responsible Pharmacist),

acting as responsible for the company………………………………………(name of the company), certify that the
information provided (above) is correct and true

(if the product is marketed in the country of origin, tick the adequate following box)

and I certify that the product offered is identical in all aspects of manufacturing and quality to that marketed
in ……………………………………..(country of origin), including formulation, method and site of manufacture,
sources of active and excipient starting materials, quality control of the product and starting material, packaging,
shelf-life and product information.

and I certify that the product offered is identical to that marketed in …………………………………..(name of
country), except: ……………………………………………………………………………………..
……………………………………………………………………………………………………………………....……..
(e.g. formulation, method and site of manufacture, sources of active and excipient starting materials, quality control
of the finished product and starting material, packaging, shelf-life, indications, product information)

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

GDF / Pharmaceutical Product Questionnaire / September 2008 Page 6 of 6