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CHAPTER 6
Operational Guidance—Male Latex Condoms
WHO/UNFPA Prequalification Scheme
Section TWO
CHAPTER 6: Operational Guidance—Male Latex Condoms
WHO/UNFPA Prequalification Scheme
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 65
All correspondence between UNFPA and the applicant m specific certification/licences required in the
will be in English. All reports on the inspections issued country for:
by the inspectors and by UNFPA will be in English. – manufacturing
– exporting
The Prequalification Scheme does not apply to m other legal documents, such as Trading
1.2 Data and information to be submitted • Applications for prequalification with supporting
Interested applicants must submit to the UNFPA focal documents should be submitted in sealed envelopes
person the following documentation in hard copy: not later than the date specified in the invitation for
EOIs, clearly marked “Application to prequalify
• covering letter, expressing interest in participat- for male latex condoms” and delivered to:
ing in the UNFPA prequalification procedure Attention: [insert name of UNFPA representative]
and confirming that the information submitted United Nations Population Fund
in the Product Dossier and Site Master File sum- Midtermolen 3, P.O. Box 2530
mary is complete and correct; DK 2100 Copenhagen 0, Denmark
• Product Dossier, in the format specified in the Tel: +45 35 46 7162, Fax: +45 35 46 7018
WHO/UNFPA guidance documents for submit- • The back of the envelope should display the
ting product data and information; information shown in the box below.
• product samples as examples of products produced;
Invitation for Expression of Interest
• a Site Master File summary, for each manufactur-
Managed by: UNFPA PROCUREMENT SECTION,
ing site listed in the Product Dossier, in the format COPENHAGEN, DENMARK
specified in the WHO/UNFPA guidance docu-
Invitation for Prequalification
ments for submitting a Site Master File summary; Country: UNFPA Headquarters
• copies of all current certifications/accreditations, Midtermolen 3, P.O. Box 2530
DK 2100, Copenhagen 0, Denmark
all manufacturing licences/registrations held, and Sector: Reproductive Health Commodities Security
a copy of the company registration;
• copies of certificates and relevant documenta- UNFPA will receive and record the EOI from each
tion as applicable in the country where the site is applicant/manufacturer and issue an acknowledgement
located, such as: of receipt.
m the certificate stating the principal place of
incorporation (for applicants that are UNFPA reserves the right to accept or reject late
corporations) applications.
66 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010
Further information may be obtained regarding prequalification from the UNFPA web site: http://www.
unfpa.org/procurement/ or by sending a written request to the Officer in Charge, Prequalification, United
Nations Population Fund, Midtermolen 3, P.O. Box 2530, DK 2100 Copenhagen 0, Denmark.
Date …………………………..
To: United Nations Population Fund
Midtermolen 3, P.O. Box 2530
DK 2100 Copenhagen 0, Denmark
Sir/Madam,
Being duly authorized to represent and act on behalf of [insert name of manufacturer] (hereinafter referred to as
the “Applicant”), and having reviewed and fully understood all the prequalification information provided, the
undersigned hereby applies to be prequalified by UNFPA as potential suppliers of male latex condoms.
Attached to this letter are copies of original documents defining:
• The Applicant’s legal status;
• Product Dossier;
• Summary of the Site Master File;
• Sample products.
UNFPA and its authorized representatives are hereby authorized to conduct any enquiries or investigations to
verify the statements, documents, and information submitted in connection with this application, and to seek
clarification from our bankers and clients regarding any financial and technical aspects.
This Letter of Application will also serve as authorization to any individual or authorized representative of
any institution referred to in the supporting information to provide such information deemed necessary and
requested by UNFPA to verify statements and information provided in this application or with regard to the
resources, experience, and competence of the Applicant.
The Applicant declares that all the information provided with the application is valid.
Name of Applicant [Organization]
__________________________________________________________________
Name of Responsible Officer ___________________________________________
Signature __________________________________________________________
Position/Title _______________________________ Date_____________ ______
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 67
1.5 Assessment of documents submitted 2 Preparation of a Product Dossier
The aim of the assessment of the submitted documen-
The Product Dossier follows the requirements
tation will be to determine whether the applicant/
included in the WHO/UNFPA Specification described
manufacturer meets the minimum requirements
in this publication, Male Latex Condom: Specification,
detailed in the relevant ISO standards and WHO/
Prequalification and Guidelines for Procurement, 2010.
UNFPA Specification in respect of product quality and
safety, production and quality management, regulatory This document is intended to provide guidance on the
approvals and capacity of production. format and content of a prequalification application
for male latex condom manufacturing sites.
UNFPA will aim to screen the documentation within
30 days of the closing date for responses to ascertain The text in this chapter is intended to be explanatory
whether it contains all the required information. If and illustrative only. The content of these sections
the submission is incomplete, the manufacturer will includes relevant information described in existing
be informed and requested to complete the dossier guidelines of the World Health Organization and the
within a specified time period. If the dossier remains International Organization for Standardization.
incomplete, it may be rejected and returned to the
applicant. Dossiers that are considered complete as the Each section including attachments should be clearly
result of the administrative screening will be retained referenced in the table of contents and in the product
by UNFPA for evaluation. file. The table of contents should list the sections,
sub-sections and titles in numerical order with the
UNFPA will exchange letters with the applicant/ corresponding page numbers. All pages should be con-
manufacturer covering provisions of confidentiality secutively numbered throughout the document.
and the process of assessment of submitted information
and, if all documentation is correct, scheduling of site
2.1 Characteristics of the products
inspection. For further information, refer to Section 2,
Provide the following information on the design of
Chapter 5.
condoms produced at this manufacturing site.
Product characteristics
Widths
Thickness range
Lengths
Shapes
Textures
Lubricant(s)
Flavours
Finishing powders
Colours
68 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010
2.2 Samples 2.5 Supplier(s)
Provide samples of the condoms (at least 10 foiled con- State the name, street address and country of each
doms of each design) produced at this manufacturing site. facility from which latex is obtained.
List the countries in which: Provide telephone number(s), fax number(s) and
e-mail addresses of all manufacturing sites associated
• the products have been registered and granted with condom production.
a marketing authorization;
• an application for marketing authorization is 2.7 Risk management of the product
currently pending; Provide the Risk Management Plan according to ISO
14971 and ISO 13485.
• any marketing approvals that have been revoked
within the last five years. 2.8 Specifications for the finished products
Answer the following questions:
2.4 Raw materials
List all raw materials, including lubricants. Use the • Do the condoms that you currently manufacture
following table as an example. meet the requirements of ISO 4074?
Add additional explanatory information if required and • Do you currently manufacture any condoms
modify the table as necessary. meeting the requirements of the WHO/UNFPA
Specification?
• If not, describe the differ-
Compounding
ences between the condoms
Chemical name Brand name Manufacturer Function you currently manufacture
and condoms that will be
produced to meet the WHO/
UNFPA requirements.
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 69
• summary reports of biocompatibility testing ments specified in the WHO/UNFPA Specification.
including, if available, toxicologists’ reports; Manufacturers that do not produce condoms to the
WHO/UNFPA Specification at the time of prequalifica-
• confirmation that neither lycopodium nor talc
tion may supply draft copy or print proofs for review.
is used;
Actual examples of printed foil, if necessary for current
• confirmation whether or not protein levels on products, should be supplied to allow assessment of the
finished products are periodically monitored; if quality of the print used for LOT number, manufac-
so, provide summary data as appropriate; turing date and expiry date.
• confirmation whether or not bioburden levels on Manufacturers should note that requirements for label-
finished products are periodically monitored; if ling and additional information may be subject to
so, provide summary data. If bioburden levels are specific contractual requirements, depending upon the
not monitored, state whether or not you are pre- requirements of the purchaser.
pared to do so in accordance with requirements
included in the WHO/UNFPA Specification.
3 Preparation of a Site Master File summary
2.10 Stability data A Site Master File (SMF) summary for each manufac-
Data supporting the stated shelf-life of the product shall turing site must be prepared and sent with the letter of
be presented. This should include data demonstrating application.
compliance with the minimum stability requirements
of ISO 4074 and real-time data from stability studies A SMF summary should be succinct and, as far as pos-
conducted at 30 °C (range 28 °C to 35 °C) according to sible, not exceed 25 A4-sized pages.
ISO 4074.
A SMF summary is a document prepared by the man-
If results from real-time studies are not available prior ufacturer from the documented quality management
to the prequalification stage, manufacturers must initi- system. It should include the following:
ate the studies immediately. Pending the outcome of
the real-time studies, manufacturers may use data from • specific factual information about the manufac-
accelerated ageing studies conducted according to the turing operations;
relevant annex of ISO 4074 to support their shelf-life
• quality assurance procedures carried out at the
claims. Procedures for conducting these studies are
named site;
summarised in Chapter 2, Clause 2.1.
• description of any closely integrated operations at
2.11 Labelling and additional information adjacent or nearby buildings.
Provide examples of the labelling that will be used for the:
If only part of a manufacturing operation is carried out
• individual packages; on the site, the SMF summary needs to describe only
the operations carried out at the site. The layout of the
• inner boxes; SMF summary should include a title page and table of
• exterior shipping cartons. contents.
Provide an example of the additional information Clauses 3.1 through 3.12, which follow, describe the
that will be supplied with the condoms, including the required contents of the SMF summary.
instructions for use.
3.1 General information
All labelling and additional information, including 1. name and exact address of the site, including fax
the instructions for use, shall comply with the require- number, e-mail, and 24-hour telephone numbers;
70 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010
2. brief information about the corporate structure, 7. a brief summary of personnel hygiene and safety
including information about holding or parent requirements, including protective clothing;
company, affiliates, subsidiaries and partners;
8. confirmation that there is a written health and
3. total manufacturing capacity of the site, including: safety policy and a summary of the key compo-
nents of this policy;
• dipping capacity
• electronic testing capacity 9. information on the use of outside scientific, ana-
• packaging capacity; lytical or other technical assistance in relation to
manufacture and analysis.
4. length of time manufacturing condoms at this
manufacturing site. Length of time manufactur-
3.4 Premises and equipment
ing condoms at other sites;
1. a simple plan or description of manufacturing
5. what other, if any, manufacturing activities take areas with indication of scale (architectural or
place at this site; engineering drawings not required);
6. summary of type of condoms manufactured at 2. the nature of construction of the building and
this site. finishes of floors, ceilings and walls;
3. a brief description of ventilation systems,
3.2 Manufacturing certifications
including steps taken to prevent product con-
A list and copies of all relevant certifications, including
tamination and excessive exposure of staff to
ISO 13485 and ISO 9000 series if applicable.
ammonia and dust;
3.3 Personnel 4. a brief description of the areas for handling
1. total number of persons employed in condom compounding ingredients;
manufacturing; 5. a brief description of procedures and arrange-
2. numbers employed, divided into the follow- ments for storing quarantined materials, work in
ing categories: senior management, production progress and finished products;
management, quality assurance, quality control, 6. a description of water systems, including sanita-
maintenance, and administration; tion and effluent treatment; schematic drawings
3. an organization chart showing all management of the systems are desirable;
and supervisory positions, including the arrange- 7. a summary of planned preventive maintenance
ments for quality assurance and quality control; programmes for manufacturing and testing
4. the qualifications, experience and responsibilities equipment;
of key personnel, senior managers, and directors, 8. a brief description of major equipment used in pro-
quality assurance supervisors, production man- duction and control laboratories, including major
ager/directors and laboratory manager/director, if computer systems used for production and quality
appropriate; control (a full list of equipment is not required);
5. a summary of policy and procedure for health 9. qualification and calibration arrangements,
requirements for personnel engaged in production; including the recording system, for computer-
6. a brief description of the staff training scheme ized systems validation, and external calibration
and the structure and maintenance of training laboratory accreditations for those laboratories
records; providing traceable calibrations;
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 71
10. availability of written specifications and procedures 3.10 Distribution, complaints and product recall
for cleaning manufacturing areas and equipment; 1. a brief description of procedures and arrange-
ments for LOT traceability;
11. a brief summary of the procedures for monitor-
ing and controlling microbiological contamina- 2. a brief description of the arrangements for manag-
tion in production areas and of the product, and ing and recording complaints and product recalls.
procedures for controlling the purity of the air
and water. 3.11 Self-inspection (internal audits)
A short description of the self-inspection (internal
3.5 Documentation audit) system.
Arrangements for the preparation, revision and distribu-
tion of all necessary management system documentation. 3.12 Corrective and preventive action
A brief description of procedures and arrangements for
3.6 Records identifying the need for and implementing corrective
Arrangements for safe storage, access and retrieval of and preventive action.
records.
3.13 Design and development
3.7 Production A brief description of procedures used to control
1. a brief description of production operations, design and development.
using, wherever possible, flow sheets and charts
and specifying important parameters; include
brief details of the scale of production; iden- 4 Scope of manufacturing site inspections
tify equipment by type (e.g. dipping machines, The objective of the manufacturing site inspection is to:
electronic testing machines); and state working
capacity where relevant; • determine if male latex condoms are consistently
2. summary of the procedures for the handling of manufactured to the required specifications;
starting materials, work in progress, packaging • verify whether the production processes occur as
materials and finished products, including prod- described in the Product Dossier and Site Master
uct release and storage; File summary.
3. a brief description of the general policy for process
UNFPA will plan and coordinate inspections at manu-
validation and a summary of the validation plan.
facturing sites to assess the manufacturing process,
the product and the quality management systems for
3.8 Risk management plan compliance with requirements specified in the WHO/
A summary of the risk management assessment under- UNFPA Specification and relevant current editions of
taken in accordance with ISO 14971. international standards including:
72 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010
• ISO 14971. Medical Devices—Application of of interest rules of UNFPA, as detailed in Section 2,
Management to Medical Devices. Chapter 5, Clauses 3 and 4.
• ISO 10993–1. Biological Evaluation of Medical The following checklist forms a guide for the manufac-
Devices. Part 1. Evaluation and Testing. turing sites inspection and details the key areas to be
• ISO 10993–5. Biological Evaluation of Medical reviewed during the inspection.
Devices. Part 5: Tests for in vitro Cytotoxicity.
Condom manufacturing sites vary widely in size, scale,
• ISO 10993–10. Biological Evaluation of manufacturing equipment and processes employed.
Medical Devices. Part 10: Tests for Irritation and Inspectors will need to use their expertise and knowl-
Sensitization. edge of condom manufacturing to tailor the inspection
checklist to the specific situation presented at each
• ISO/IEC 17025. General Requirements for
inspection site.
the Competence of Testing and Calibration
Laboratories. To ensure a standardized approach, each team will
perform the inspections and report on its findings to
The inspection will be performed by a team of inspec-
UNFPA in accordance with the SOPs established by
tors, consisting of experts appointed by UNFPA, who
UNFPA for that purpose.
will act as temporary advisers to UNFPA. The inspec-
tors must have documented qualifications; expertise in Information submitted in response to the EOI and the
male latex condom manufacturing, auditing and qual- assessment report will be made available to the inspec-
ity management systems; and specific experience with tors. All inspectors must comply with the confidential-
inspecting condom manufacturing sites. The inspectors ity and conflict of interest rules of UNFPA as detailed
must comply with the confidentiality and conflict in Section 2, Chapter 5, Clauses 3 and 4.
Inspectors will require access to all documents and records related to the manufacture of specific male latex
condoms as indicated in ISO 4074 and the WHO/UNFPA Specification.
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 73
Areas under inspection Comments
2. Management team and key staff
3. Human resources
Records
4. Production capacities throughout the operation
Environment
Process
Adequacy of equipment
Environment
Process
Adequacy of equipment
Environment
74 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010
Areas under inspection Comments
8. Dipping
Process
Adequacy of equipment
Environment
Materials used
Process
Adequacy of equipment
Environment
Process
Adequacy of equipment
Environment
11. Foiling
Materials used
Process
Adequacy of equipment
LOT coding
Environment
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 75
Areas under inspection Comments
12. Consumer/customer packing
Materials used
Process
Adequacy of equipment
Environment
13. Warehousing
Adequacy
Segregation
Labelling
Stock control/rotation
Agreements
Records
Segregation
Labelling
Status identification
Environment
Security
Quality manual
76 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010
Areas under inspection Comments
Documentation and structure
Document control
Process approach
Records
Contract review
Post-market surveillance
Internal audit
Product Dossier
19. Maintenance
Records of maintenance
Adequacy of maintenance programme
Reporting of results
Documentation
Calibration system
Certifications
Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 77
Areas under inspection Comments
21. Shelf-life stability
Compressed air
Effluent treatment
Electricity
Sampling
Results summary
The reports from each site visit will be structured in accordance with UNFPA’s SOPs.
78 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010