WHO/UNFPA Prequalification Programme for Male and Female Condoms:
UNFPA manages the Male Latex Condom and Female Condom Prequalification Programmes for the UN system. The Prequalification Schemes were developed by WHO in 2001 with the support of UN and other partner agencies. Although WHO delegated the management of this program to UNFPA in 2005, WHO still maintains the normative role in setting guidelines and requirements for the prequalification programmes. The prequalification process, based on international ISO standards and WHO/UNFPA specification guidelines, entails the following:
|Updated September 2014|
- Response to an Expression of Interest (EOI) by applicant.
- The EOI is posted on the United Nations Global Marketplace (www.ungm.org)
- Submission of required documents by applicant
- Product approval by WHO/UNFPA Female Condom Technical Review Committee (for female condoms only)
- Review of submitted documents by technical experts
- Inspection of the manufacturing facility by certified inspectors *
- Sampling and testing of products by an independent, ISO 17025 accredited laboratory
- Continuous quality monitoring
- Re-qualification every three years
* Products and their associated manufacturing sites that have successfully completed the prequalification process are included in the prequalification lists and eligible to bid for UNFPA tenders.
Female Condom Technical Review Committee
Unlike male condoms, female condoms may come in many possible designs and can be made from different materials in diverse shapes and come with different components. As such, it is necessary to conduct clinical investigations to assess the overall performance of the device’s features, failure modes, and safety and effectiveness. This must be demonstrated through a contraceptive efficacy study or functionality study as detailed in the WHO/UNFPA Specification. As a result, WHO/RHR has developed a review process for each product seeking prequalification whereby it is reviewed by a Technical Review Committee with members possessing expertise in female condom research, manufacturing, testing, and regulation. The UNFPA Female Condom Prequalification Scheme is integrated with the WHO/RHR Technical Review Process. The first Technical Review Committee for Female Condoms was convened in 2006 and it reviewed several designs of the female condom. The Technical Review Process established the criteria for the product and production processes to be adequately documented and for demonstrating the safety and efficacy of the product. The detailed report from this meeting outlines the Technical Review Process and the members of the Technical Review Committee.
The next meeting of the Female Condoms Technical Review Committee is scheduled for June 2014 in Copenhagen, Denmark. Applicants who would like to have their products reviewed during this meeting should contact firstname.lastname@example.org
UNFPA’s Quality Criteria for Procurement of Male and Female Condoms:
UNFPA only procures prequalified products that adhere to the requirements of most recent editions of the WHO/UNFPA specifications for male and female condoms from sources that have successfully completed the prequalification process. Quality control measures are also implemented after suppliers have been prequalified. Every batch of condoms purchased by UNFPA undergoes pre-shipment sampling and testing. This process begins with the inspection and sampling of the products by a third party that confirms the quantity, labelling, packaging materials and markings are in compliance with the requirements in the UNFPA purchase order.
The sampled condoms are then sent to third party independent testing laboratories for pre-shipment quality control testing. Laboratories that conduct pre-shipment testing for male and female condoms must be ISO 17025 accredited for the testing of that product
UNFPA recommends post-shipment testing only when there is evidence that condom integrity was compromised during transportation or for batches which are not part of a pre-shipment testing scheme.
The publications, WHO/UNFPA Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010**, and WHO/UNFPA Female Condoms: Specification, Prequalification and Guidelines for Procurement, 2012 contain detailed information on the WHO/UNFPA specification and prequalification processes for male and female condoms. The guidelines highlight key issues that are relevant to applying a technically sound, systematic process to support the manufacture, prequalification, testing, procurement and distribution of the products and is intended for any policy maker, programme manager or procurement officer who has the responsibility for supplying or promoting male and/or female condoms.
In line with the ISO 4074:2014 that was recently published, UNFPA will be implementing new requirements from the new ISO standard, with an effective date of April 1st 2015:
Please also note the following:
Shelf Life Studies: Any new studies to be commenced from now, should start following the new ISO standard (ISO 4074:2014). Any studies from the ISO 4074:2002 standard will still be accepted as long as there has been no changes in formulation.
Nitrosamine Levels: It is also requested that nitrosamine levels be monitored and checked once a year to be below 100. Tests for nitrosamine levels should also be done again if there is a change in formulation.
* UNFPA invites Regulatory Authorities and Ministries of Health to participate in WHO/UNFPA Prequalification Process and partake in on-site inspections. For more information on how to become involved, please contact email@example.com
** The WHO/UNFPA Male Latex Condom: Specifications, Prequalification and Guidelines for Procurement, 2010 was updated in 2013 and a corrigendum has been issued for the printed versions of the book. Please click here for the printable version of the corrigendum in English. Corrigendum is also available in French and Spanish.