TECHNICAL AND COMMERCIAL REQUIREMENTS
FOR THE PRE-SELECTION AND
QUALITY ASSURANCE OF ARTESUNATE, POWDER FOR
INJECTION
PROCURED THROUGH THE USAID | DELIVER TO7 PROJECT.
1.0 PRODUCT IDENTIFICATION AND APPROVAL REQUIREMENTS
a)
The USAID | DELIVER PROJECT is seeking manufacturers of the following
product:
Generic Name: Artesunate for injection
Strength: Artesunate 30 mg/vial, Artesunate 60 mg/vial or Artesunate 120 mg/vial
Artesunate for Injection Pharmaceutical Form: Powder
Solvent/s Pharmaceutical Form: Liquid
b) To be considered for pre-selection by the USAID | DELIVER PROJECT
manufacturer’s product must either be approved by a Stringent Regulatory
Authority or be WHO Pre-Qualified. Expert Review Panel recommendation is
not accepted.
2.0 MINIMUM DOCUMENTATION REQUIREMENTS
The manufacturer must provide documentation that includes at a minimum:
a) Evidence of valid product approval by a Stringent Regulatory Authority or WHO
Pre-qualification.
b) Past Performance References – Details of past performance on major supply
contracts with details of the client, donor, end user/program together with referee
contact details
c) Financial Statements – the last three years audited Year End financial statements
d) Legal Capacity - Legal certificate of registration / incorporation of the
manufacturer
John Snow, Inc.
1616 North Fort Myer Drive, 16th Floor
Arlington, VA 22209 USA
www.deliver.jsi.com
Phone: 703-528-7474
Fax: 703-528-7480
Email: deliver_project@jsi.com
e) Production Capacity - A statement of current production output capacity and any planned
changes.
f) In-country Registration - Details of any applicable registration with regulatory in-country
authorities
3.0 ADDITIONAL QUALITY DOCUMENTATION REQUIREMENTS
a) Potential manufacturers supplying pharmaceutical commodities for the USAID |
DELIVER PROJECT are required to provide documentation of their manufacturing
capabilities, technical and specifications standards of the processes used to manufacture
the pharmaceutical product.
b) However, if the manufacturer has previously provided such documentation to the USAID
| DELIVER PROJECT in the past year, then it is not required to resubmit that
information in response to this EOI.
c) If the manufacturer has not previously provided such documentation to the USAID |
DELIVER PROJECT then the manufacturer must complete Appendix A
“PROCUREMENT QUESTIONNAIRE for PHARMACEUTICAL DRUG
MANUFACTURERS” and provide all required documentation.
d) The USAID | DELIVER PROJECT reserves the right to request additional information,
documentation and product samples as required from all manufacturers.
e) The USAID | DELIVER PROJECT reserves the right to make multiple pre-selections, no
pre-selections or to cancel this request for Expressions of Interest at its sole discretion.
APPENDIX A
PROCUREMENT QUESTIONNAIRE
for
PHARMACEUTICAL DRUG MANUFACTURERS
Potential manufacturers supplying drug products for the USAID | DELIVER PROJECT are required to provide documentation of
their manufacturing capabilities, technical and specifications standards of the processes used to manufacture the pharmaceutical
product. If any process or service directly related to the manufacturing of the product(s) is subcontracted, a separate
documentation packet must be submitted for the subcontractor. Documents in languages other than English must include a
translation and should be submitted in addition with the original non-translated document.
DATE of REQUEST: ________________________
PHARMACEUTICAL DRUG PRODUCT
TO BE PROCURED:
1
Product Identification:
2
Generic Name of the product:
3
Trade name (if any):
4
Dosage Form:
5
Strength per dosage unit:
6
Route of administration:
7
9
10
11
Pack size and description of primary
packaging materials
Pack size and description of secondary
packaging materials
Available product amount
Date when product available
Country Destination:
12
I, the undersigned,
8
 Tablets
 Capsules
 Injectable
 Syrups/oral liquids
 Oral
 I.M.
 I.V.
 S.C.
 Other:
 Other
COMMITMENT:
…………………………………………………..,
(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 (below) is correct and true.
13
14
15
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)
Signature:
Date:
MANUFACTURER INFORMATION:
16
MANUFACTURER of DRUG PRODUCT:
List all facilities, including API’s
Contact Information:
All sites listed are licensed by the relevant National Regulatory Authority to
perform the activity?
 Yes
 No
17
SUPPLIER(Wholesaler) of DRUG PRODUCT if applicable:
18
PLEASE INDICATE GMP REGULATORY STATUS OF FACILITY(s)
Contact Information:
Agency
Date of Approval
Agency
Date of Approval
FDA
Note 1- Stringent Regulatory Authority
A stringent regulatory authority (SRA) is a drug regulatory body that closely resembles FDA
in standards utilized in its operations. Currently countries that participate in the International
Conference on Harmonization (ICH) are considered as stringent regulatory authorities. The
ICH regulatory bodies include: the USFDA: the Japanese Ministry of Health, Labor, and
Welfare: the European Agency for the Evaluation of Medicinal Products (EMEA) centralized
procedure: and the European Free Trade Area (represented by the Swiss Medic). The
Canadian drug regulatory authority, the Therapeutic Products Directorate,Health Canada, is an
observer to the ICH and is also considered a stringent regulatory authority. Other countries
may be considered having a stringent regulatory body if they have implemented ICH
guidelines and resemble the USFDA in operation, but would be considered on a case-by-case
basis.
SRA¹ (Stringent Regulatory
Authority)
WHO-Pre-Qualification Program Geneva
UNICEF Supply Division
Copenhagen
International Conference on
Harmonization of Technical
Requirements for Registration of
Pharmaceuticals for Human Use.
Pharmaceutical Inspection
Cooperation Scheme (PICS)
MSF International
ICRC Geneva
In-COUNTRY GMP
Other
19
PLEASE INDICATE GMP REGULATORY STATUS OF PRODUCT
FDA
SRA¹ (Stringent Regulatory
Authority)
WHO-Pre-Qualified
COUNTRY
Other
20
Any other GMP Inspections/Regulatory license information?
21
Product Dossier submitted to WHO PQ Program for review;
Status:
22
Product registered and currently marketed;
License no.
 Yes
23
Product registered for marketing in the country of manufacturing but not
currently marketed;
 Yes
24
 No
 No
Product registered for export only;
 Yes
License no.
License no.
 No
25
Product not registered
Status:
26
List other countries where the product is registered and currently
marketed and include registration number.
Country(s)
Registration Number
Required Documents and Questionnaire
27
28
29
30
31
32
33
Provide a Certified copy of current license in country where primary manufacturing is conducted.
A copy of Drug Dossier including Drug Master File (DMF) or a brief description of the
manufacturing procedure for the product(s) being subject to this questionnaire (only if DMF is not
applicable or available).
Provide a Certified Letter of Authority indicating company contacts for Management, Quality
Control, Quality Assurance and Production.
Provide the Manufacturer’s Quality Manual and applicable Standard Operational Procedures in
Microsoft-Word compatible CD form.
Provide a copy of the Certification that the commodities are manufactured according to EN, ISO,
WHO, GMP, FDA standards, whichever applies.
Provide a copy of the Company’s environmental policy and any citations, infractions, fines, or legal
actions the company has been involved in as a result of violations.
Attach Organizational Chart
34
Provide a copy of the Manufacturing Authorization according to the drug law of your country.
35
Provide a copy of the drug product complaint procedure.
36
Provide a copy of the adverse event reporting procedure.
37
Provide a copy of test failure investigation procedure with an example of an investigation report.
38
Provide a copy of the accelerated drug stability studies.
type and conditions of
testing:
Type and material of
container:
Date of beginning of the
study
39
41
Conditions (Temperature/Relative
Humidity/Duration):
Number of batches:
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
Accelerated Stability testing data:
 Yes
 No
:
Real-time Stability testing data :
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
Number of volunteers
Bio batch API(s) source(s)
Year
Provide bioequivalence study(s) - b.)  by another method claimed by the supplier/manufacturer (please
describe briefly):
42
 Yes
Batch sizes:
Provide bioequivalence study(s) - a.)  by in vivo bioequivalence studies
Reference product
CRO Name
country of study
 No
Batch sizes:
Provide a copy of the real-time drug stability studies.
type and conditions of
testing:
Type and material of
container:
Date of beginning of the
study
40
Conditions (Temperature/Relative
Humidity/Duration):
Number of batches:
 Yes
Provide bioequivalence study(s) - c.)  by comparative in vitro dissolution tests
According to conditions described in WHO BCS classification document (WHO Technical Report Series N°937)
Reference product
43
44
45
46
Provide bioequivalence study(s) - d.)  by in vitro dissolution tests
Provide bioequivalence study(s) - e.)  not demonstrated
Provide bioequivalence study(s) - f.)  not relevant, please explain why:
If API’s are manufactured from other facilities, provide GMP certificates.
47
If the drug product is not listed in the international pharmacopeias, provide a copy of the test
method.  No Pharmacopoeia monograph exists*
 BP
 USP  EP
 International Pharmacopoeia
Attach a copy of the API(s ) internal specifications
48
49
50
Provide a package product insert
Provide a Certificate of Analysis for the drug product
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?
51
Is there documentation of employee training for SOPs, GMP’s, Safety?
52
Is quality testing performed on-site?
53
Any quality testing sub-contracted?
54
Does your facility have a formal system by which engineering changes are evaluated for process,
product, regulatory, and environmental impact prior to implementation?
Is microbiological monitoring performed on a regular basis for:
55
Raw materials
Yes 
Product
Yes 
Air, floor, walls, machines/equipment Yes 
Personnel
Yes 
Water
Yes 
No 
No 
57
Are corrective and preventive actions addressed and recorded?
58
Does your facility have procedures to protect the integrity, confidentiality and safety of records?
61
Do you prepare Annual Quality Review Reports for each drug product?
Are quarantined raw materials/finished products and rejected raw materials/finished products clearly
identified, segregated and documented?
Are conditions for storage areas controlled and monitored?
62
Are these systems alarmed?
63
Do you use the same warehouse for the storage of incoming components and final APIs/Products?
64
Explain lot numbering system.
65
Are qualification, maintenance and calibration records maintained for each piece of equipment?
66
Do you have a documented validation program for manufacturing processes?
67
Is there a system to identify each major piece of equipment?
68
Does the facility have adequate lighting, ventilation, dust control, vector control,
and proper physical barriers to prevent cross contamination?
69
70
71
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
No 
Does your company perform internal audits on a regular basis?
60
 No
No 
No 
56
59
 Yes
 JP
What grade of water is used during synthesis or formulation of APIs and/or finished product?
Are all points of use and sampling clearly identified?
Is the manufacturing facility dedicated exclusively to the product(s) being subject to this
questionnaire?
If no, list other products and describe what measures are in place for preventing cross-contamination in terms of
mixing ingredients, records and labels.
72
Do water pipes indicate contents and direction of flow?
73
Is there a written procedure for cleaning methods?
74
Was cleaning procedure validated?
75
Describe in-process quality checks
76
Describe Finished product quality checks
77
Is there a procedure and follow-up documentation to confirm label compliance?
78
Is product(s) being subject to this questionnaire re-packed or re-labeled after it leaves manufacturer?
79
Is there a Master label file for all labels?
80
Is packaging accountability and variance verified?
81
Are retain samples maintained for each lot of product shipped?
82
Is there a written procedure for investigating complaints?
83
84
90
Are complaints analyzed for trends and CAPA implemented?
Is there a product recall procedure?
Please provide contact person(s) in case of recall or adverse event reporting;
Submit Questionnaire Package to;
Mr. Christopher Guy – Deputy Director Procurement USAID | DELIVER T07
John Snow Inc.
1616 N. Fort Meyer Dr. 16th Floor
Arlington, VA. 22209
USA
Email: cguy@jsi.com
91
Submit a copy of Questionnaire Package to;
Mr. David Jenkins – Quality Assurance USAID | DELIVER
FHI 360
2810 Meridian Parkway,
Suite 160 | Durham, NC 27713
USA
Email: djenkins@fhi360.org
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No
 Yes
 No