Interagency Pharmaceutical Product Questionnaire

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 / E-mail
Technical specifications & product quality / Tel:
Cell:
Regulatory & patent / Tel:
Cell:
Commercial/business and general inquiries / Tel:
Cell:

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 Most recent submission date

MSF Most recent submission date

UNICEF Most recent submission date

WHO Most recent submission date

Other (specify) Most recent submission date

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

1.2. Further Identification OF ARV & ACT

* Please use the following pharmaceutical forms to describe your pharmaceutical entity

Tablets / Capsules / Oral liquids
ü  Scored
ü  Solid
ü  Dispersible
ü  Chewable
ü  Buffered (→ Specify buffers)
ü  Film coated
ü  Enteric coated
ü  Sublingual
ü  Bilayer
ü  Delayed release
ü  Controlled release
ü  Other (→ Specify) / ü  Enteric coated
ü  Delayed release
ü  Controlled release
ü  Sublingual
ü  Other (→ Specify) / ü  Solution
ü  Suspension
ü  Powder for liquid
ü  Powder for suspension
ü  Other (→ Specify)
Injectables / Oral powder
ü  Solution for Injection
ü  Powder for Injection
ü  Oily Injection
ü  Infusion

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
Active Ingredient

Co-formulated Fixed Dose Combination (FDC)

Content / Active Pharmaceutical Ingredient / Amount in dosage form
or Amount per unit / Pharmaceutical forms * Use all that apply from selection above / Route(s) of administration
Active Ingredient 1
Active Ingredient 2
Active Ingredient 3

Co-pack

Content / Active Pharmaceutical Ingredient / Amount in dosage form
or Amount per unit / Pharmaceutical forms * Use all that apply from selection above / Route(s) of administration
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):

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 / Manufacturing license No. / Valid until / Issuing Agency / Country
Manufactures APIs (Drug substance)
Manufactures Finished Drug Product
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 Date: Outcome:

National Regulatory Authority Date: Outcome:

UNICEF Supply Division Date: Outcome:

MSF Date: Outcome:

ICRC Date: Outcome:

USFDA Date: Outcome:

PIC’s members (specify) Date: Outcome:

Other (specify) Date: Outcome:

→ Attach GMP certificate(s) of finished pharmaceutical product manufacturing site (s)

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!

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.

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 Iva

Zone II Zone IVb

Zone III Other (specify)

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Storage conditions

Specific storage conditions for this product as it appear on the packaging and based on stability studies:

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:

9.  THERAPEUTIC EQUIVALENCE

Therapeutic Equivalence studies are:

1.1.  Not relevant, Please explain why:

1.2.  Not demonstrated, Please explain why:

1.3.  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):

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 suitabilityto 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

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Annex 2 – DP 046 Rev 04- Pharmaceutical Product Questionnaire

Yes

API specifications (tick as appropriate):

BP Edition: Volume:

USP Edition: Volume:

Ph.Eur. Edition: Volume:

Ph.Int. Edition: Volume:

Other/in-house (specify):

Enter 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

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: 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