Prequalification Programme for Female Condoms

Prequalification, specifications and guidelines

2012
Author: UNFPA

WHO/UNFPA Prequalification Programme for Female Condoms

UNFPA manages the Female Condom and Male Latex 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:

  • Response to an  Expression of Interest  (EOI) by applicant
  • The EOI is posted on the United Nations Global Marketplace
  • 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

Please click here for the full list of female condom manufacturing sites that have successfully completed the UNFPA/WHO Prequalification Process. 

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 last meeting of the Female Condoms Technical Review Committee was in June 2014 in Copenhagen, Denmark.
 

UNFPA 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.