United Nations Children’s Fund
Supply Division
UNICEF Plads, Freeport
DK-2100 Copenhagen Ø
Denmark
Telephone
Facsimile
E-mail:
+45-35 27 35 27
+45-35 26 94 21
supply@unicef.org
www.unicef.org/supply
INTERAGENCY PHARMACEUTICAL PRODUCT QUESTIONNAIRE
Note for the applicant: Please fill one form separately for each finished pharmaceutical product (FPP).
The information in this questionnaire may be shared confidentially amongst WHO, ICRC, MSF and UNICEF for
procurement purposes. If you have any objection, please indicate in the section provided at the end of this
questionnaire.
Request for Proposal Number/Invitation to Bid
Number
Dated
Name of item
Name of company submitting Bid
CONTACT DETAILS FOR RESPONSIBLE PERSONS
Subject
Name of contact person
Telephone and cell
phone
Technical specifications
& product quality
Tel:
Cell:
Regulatory & patent
Tel:
Cell:
Commercial/business
and general inquiries
Tel:
Cell:
E-mail
If you have previously filled an IAPPQ form and provided the necessary information in relation to this
product, please indicate below (all that apply)
ICRC
MSF
UNICEF
WHO
Other (specify)
Most
Most
Most
Most
Most
recent
recent
recent
recent
recent
submission
submission
submission
submission
submission
date
date
date
date
date
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 1 of 12
1. FINISHED PHARMACEUTICAL PRODUCT (FPP) IDENTIFICATION
1.1.IDENTIFICATION
Active Pharmaceutical Ingredient(s) – use the approved non-proprietary name (INN) of the product:
Generic name of the product:
Brand/trade name (if any):
Dosage form:
Tablets
Capsules
Injectable
Syrups/oral liquids
Other, please specify:
Strength per dosage unit:
Route of administration:
Oral
I.M.
I.V.
S.C.
Other, please specify:
Number of dosage units per unit (primary) pack
Numbers of unit packs per secondary pack
(Multiples of unit packs)
Description and composition of primary
packaging materials
Description and composition of secondary
packaging materials
Packed with dispensing devices
Co-packed with (e.g. diluents…)
Language(s) of
Label, packaging and pack insert
English
French
Other (Specify)
Inactive Ingredients (excipients) of medical/pharmaceutical relevance, amount in dosage form or per
dosage unit (e.g. Contains Alcohol 10%):
Formulation of the product (complete qualitative and quantitative composition including active
ingredient(s) and excipients:
→ Attach
a flow diagram describing the manufacturing and control processes with relevant
parameters
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 2 of 12
1.2.FURTHER IDENTIFICATION OF ARV & ACT
* Please use the following pharmaceutical forms to describe your pharmaceutical entity
Tablets
 Scored
 Solid
 Dispersible
 Chewable
 Buffered (→ Specify buffers)
 Film coated
 Enteric coated
 Sublingual
 Bilayer
 Delayed release
 Controlled release
 Other (→ Specify)
Capsules
 Enteric coated
 Delayed release
 Controlled release
 Sublingual
 Other (→ Specify)
Oral liquids
 Solution
 Suspension
 Powder for liquid
 Powder for suspension
 Other (→ Specify)
Injectables
 Solution for Injection
 Powder for Injection
 Oily Injection
 Infusion
Oral powder
Single Pharmaceutical entity
Content
Active Pharmaceutical
Ingredient
Amount in dosage
form
or
Amount per unit
Pharmaceutical forms
* Use all that apply
from the selection
above
Route(s) of
administration
Amount in dosage
form
or Amount per unit
Pharmaceutical forms
* Use all that apply
from selection above
Route(s) of
administration
Amount in dosage
form
or Amount per unit
Pharmaceutical forms
* Use all that apply
from selection above
Route(s) of
administration
Active Ingredient
Co-formulated Fixed Dose Combination (FDC)
Content
Active Pharmaceutical
Ingredient
Active Ingredient 1
Active Ingredient 2
Active Ingredient 3
Co-pack
Content
Active
Pharmaceutical
Ingredient
Content of item 1 in co-pack
Content of item 2 in co-pack
Content of item 3 in co-pack
2. BIDDER – SUPPLIER IDENTIFICATION
Name of company submitting BID
Physical address
Postal address
City, Country
Telephone, Fax
E-mail
Link with the product
Marketing license holder
Distributor/wholesaler
Manufacturer
Other (Please specify):
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 3 of 12
3. MANUFACTURER IDENTIFICATION
Repeat this section for each manufacturing site relevant to this product
Details of manufacturer and manufacturing site
Name of manufacturer
Physical address of manufacturing site(s),
including unit/block number
Postal address
City, Country
Telephone, Fax
E-mail
Activities of the manufacturer (Fill in all that apply)
ACTIVITIES OF
MANUFACTURER
Manufactures APIs
(Drug substance)
Manufactures
Finished Drug Product
Manufacturing
license No.
Valid until
Issuing Agency
Country
Primary Packaging
Secondary packaging
Contract Manufacture
Other (Specify)
WHO GMP inspection
WHO GMP certificate no
Valid until
Issued by: Agency
Country
GMP inspections carried out by (tick all that apply):
WHO Prequalification programme
National Regulatory Authority
UNICEF Supply Division
MSF
ICRC
USFDA
PIC’s members (specify)
Other (specify)
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Date:
Outcome:
Outcome:
Outcome:
Outcome:
Outcome:
Outcome:
Outcome:
Outcome:
→ Attach GMP certificate(s) of finished pharmaceutical product manufacturing site (s)
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 4 of 12
4. REGULATORY SITUATION (LICENSING STATUS)
Product registration in-country
Product not registered in country of manufacture (please clarify):
Product registered and currently marketed in the country of manufacture
License no
Valid until
Issued by: Agency
Country
Product registered for marketing in the country of manufacture but not currently marketed
License no
Valid until
Issued by: Agency
Country
Product registered for export only
License no
Valid until
Issued by: Agency
Country
→ Provide copies of all licenses that apply
CPP
Reference Number
Valid until / Date
prequalified / Date of
dossier submission
Issued by –
name of
Agency
Country
Certificate of
Pharmaceutical
Product (CPP)
→ Attach CPP according to the WHO Certification Scheme - WHO Technical Report Series
No.863. (earlier version is not acceptable) or equivalent document.
If CPP cannot be obtained from the National Drug Regulatory (NDR), please state the reason and send
equivalent document if any:
Product registration in other countries
The product is registered/licensed and currently marketed in the following countries:
Country
License No.
Valid Until
Issuing Agency
To insert more rows if necessary!
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 5 of 12
5. WHO PRE-QUALIFICATION STATUS
Not applied for WHO prequalification (Explain)
YES:
Reference Number
Valid until / Date prequalified /
Date of dossier submission
WHO Prequalification
Application to WHO
Prequalification
→ Attach Copy of the relevant WHO Pre-qualification approval letter signed by your company
OR
→ Attach WHO acceptance letter for product dossier review mentioning the WHO reference
number assigned by WHO for this specific product
6. FINISHED PRODUCT SPECIFICATION
Monograph specifications
EDITION
YEAR PUBLISHED
BP
USP
Ph.Int
In house, Year documented
Explain
Indicate any additional specifications to those in the pharmacopoeia (e.g.
dissolution, syringe ability)
Have the manufacturing methods for each standard batch size been validated?
Yes
No, please clarify:
List the validated standard batch sizes:
→ Attach Validated analytical methods if specifications for finished product are in-house
specifications, different from BP, USP and Ph.Int.
→ Attach a copy of the Internal Finished Product Specifications.
→ Attach a copy of Certificate of Analysis for the last 3 batches released.
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 6 of 12
7. STABILITY OF FINISHED PRODUCT
Stability testing data available
No
(Explain)
Yes
Indicate type and conditions of Testing:
Stability testing done on (tick all that applies):
Pilot batch (Not less than 10% of full production batch)
Production batch
Satisfactory accelerated testing at (State the months)
Type and material of packaging
Conditions (Temperature/Relative Humidity/Duration)
Number of batches
Batch sizes
Date of beginning of the study
Date of end of study
Satisfactory real time testing at (state the months)
Type and material of container
Conditions (Temperature/Relative Humidity/Duration)
Number of batches
Batch sizes
Date of beginning and end of the study
Stability testing has been 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:
→ Attach copies of testing protocols
→ Attach copies of study results, including graphical/pictorial interpretations where applicable
Stability studies for this product is on-going
Yes
No
→ Attach status report of any on-going stability studies
Shelf life
Guaranteed shelf life (Based on stability studies)
Maximum possible shelf life
Shelf life as it appears on the packaging
Shelf life after primary package is open or product is
reconstituted
Stability
Product suitable for use in:
Zone I
Zone II
Zone III
Zone Iva
Zone IVb
Other (specify)
Storage conditions
Specific storage conditions for this product as it appear on the packaging and based on stability studies:
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 7 of 12
8. SAMPLES FOR TECHNICAL EVALUATION
Product sample provided:
No
→ Attach label artwork/copy of actual label
→ Attach pack insert/leaflet
Yes
Shelf life on sample
Storage conditions on sample
Pack insert available Y/N
The product sample provided conforms in all forms to the product offered and as it will be supplied on
purchase
Yes
No (explain):
→ Attach a Certificate of Analysis relevant to the sample
NB: If you are not able to provide a Certificate of Analysis, please explain:
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 8 of 12
9. THERAPEUTIC EQUIVALENCE
Therapeutic Equivalence studies are:
1.1.
1.2.
1.3.
Not relevant, Please explain why:
Not demonstrated, Please explain why:
Demonstrated
By in vivo bioequivalence studies
Study period (dd/mm/yyyy):
from
- to
Reference product
Name, dosage form and strength
Manufacturer and manufacturing site
Study protocol
CRO Name
Country of study
Number of volunteers
Study design (describe in detail)
Bio batch size
Bio batch number
Bio batch API(s) source(s)
Study conclusion
By comparative in vitro dissolution tests
Reference product
Name, dosage form and strength
Manufacturer and manufacturing site
Name and contact details of Laboratory
performing tests
NB: Reference product must have undergone successful in vivo bioequivalence studies
According to conditions described in WHO BCS classification document (WHO Technical
Report Series N°937 or later)
Yes
No (explain):
BCS class:
Study conclusion
By another method claimed by the supplier/manufacturer to be appropriate
Please describe briefly the method used
Study conclusion:
For all methods
→ Attach schematic representation of study design
→ Attach study protocol summary
→ Attach graphic/pictorial representation of summary study results
→ Attach full reports of all studies done to prove therapeutic equivalence with clear study
conclusions
FINAL STATEMENT OF MANUFACTURER
The product used in the therapeutic equivalence study specified above 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 (explain what the differences are):
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 9 of 12
10.
ACTIVE PHARMACEUTICAL INGREDIENTS(S) (API’S)
In case more than one API or manufacturer is used, please replicate this section!
Name of API (INN if available)
Certificate of suitability to the European
Pharmacopoeia (CEP) No
The open part of the Drug Master File
(DMF) is registered in (Country)
Name of original manufacturer
Physical address of manufacturing site(s)
including unit/block number
City, Country
Certificate of analysis (for API)
→
Attach a copy of the model certificate of analysis for batch release of API
Manufacture of APIs (Drug substance)
License no
Valid until
Issued by: Agency
Country
GMP certificate (for API)
License no
Valid until
Issued by: Agency
Country
→
Attach copy of GMP certificate of API/Intermediates manufacturing site
Specifications and standard test methods exist for this API
No
Yes
API specifications (tick as appropriate):
BP
Edition:
USP
Edition:
Ph.Eur.
Edition:
Ph.Int.
Edition:
Other/in-house (specify):
Enter
Volume:
Volume:
Volume:
Volume:
no. Pharmacopoeia monograph exists*)
*) Attach a copy of the API(s) internal specifications and analytical methods if not yet WHO prequalified.
→ Attach copy of internal API specifications
→ Attach a copy of analytical methods for products with in-house or specifications other than
those listed above
→ Attach certificate of analysis of the last production batches of API from the API
manufacturer
→ Attach certificate of analysis of API from the finished product manufacturer
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 10 of 12
COMMITMENT
I (Full Name)
, Certify that:
The product offered is identical in all aspects of manufacturing and quality to that prequalified by WHO
Ref No
, 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.
OR
The product offered is identical in all aspects of manufacturing and quality to that USFDA tentatively
approved Ref
, 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.
OR
The product offered is identical in all aspects to that registered and marketed
in
(name of country)
Explain any exceptions
Signature
Date
AUTHORIZATION
I, the undersigned confirms that the company has no objection of the information contained herein being
shared with the agencies listed on page 1 except
I, the undersigned, certify that the information provided above is accurate, correct, complete, up to date
and true at the time of submission
Full name:
Full title/position in company:
Company name:
Signature
Date
Telephone number:
Email:
Company seal/stamp:
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 11 of 12
Annex: Check list of attachments required
Please ensure that all documents necessary to enable objective evaluation of your product are attached.
This checklist may not be exhaustive.
Formulation of the product (complete qualitative and quantitative composition including active
ingredient(s) and excipients
Flow diagram describing the manufacturing and control processes with relevant parameters
GMP certificate(s) of finished pharmaceutical product manufacturing site (s)
Certificate of Pharmaceutical Product (CPP) according to the WHO Certification Scheme
Copy of the relevant WHO Pre-qualification approval letter signed by your company
WHO acceptance letter for product dossier review mentioning the WHO reference number assigned by
WHO for this specific product
Copy of internal finished product specifications
Copy of the certificate of analysis for the 3 last batches released
Validated analytical methods if specifications for finished product are in house specifications, different
from BP, USP and Ph.Int
Protocol and report for accelerated and real time stability testing
Description and composition of primary packing materials
Description and composition of secondary packaging materials
Product registration licenses in country of manufacture
Sample of the finished product(s) offered together with COA relevant to sample
Label artwork /copy of actual label
Package insert/leaflet
Copy of the report of the proof of therapeutic equivalence (BE study, comparative dissolution profile,
dissolution tests, etc including graphic presentations).
GMP certificate(s) of API manufacturing site
Copy of internal API specifications
Validated analytical methods in case of in house API specifications
Copy of the certificate(s) of analysis of the API from the API manufacturer as well as from the FP
manufacturer
Copy of the Certificate of suitability to the European Pharmacopoeia CEP and its annexes
________________________________________________
Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire
Page 12 of 12