Prequalification Programme for Male Latex Condoms

Prequalification, specifications and guidelines

Publication Date: April 2020

Please refer to Annex 10 of the WHO Technical Report series no.1025 for the WHO/UNFPA Technical Specification for male latex condoms

 

WHO/UNFPA Prequalification Programme for Male 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:

  • Response to an  Expression of Interest  (EOI) by applicant
  • Submission of required documents by applicant
  • 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 male condom manufacturing sites that have successfully completed the UNFPA/WHO Prequalification Process.
 
Annex 10: WHO/UNFPA technical specifications for male latex condoms  
 

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.

 

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