As the leading procurement agency for contraceptives, the United Nations Population Fund (UNFPA) has to be able to ensure that all commodities supplied live up to the highest international standards at all times, since it is in the mandate of UNFPA to take a lead role in reproductive health commodity security. Hence, quality assurance of reproductive health products is a vital part of the work of UNFPA. In order to fulfil the mandate of ensuring reproductive health commodity security, a prequalification process for manufacturers of IUDs and condoms willing to become suppliers of the whole UN system has been carried out since 2001.
The prequalification process, which is implemented in line with the World Health Organization (WHO) standards, consists mainly of the following steps:
- Review and evaluation of manufacturers’ documentation; Quality Manual, ISO Certificates, Product Dossier and Site Master File
- On-site factory inspection by certified consultants
- Sampling and testing
- Maintenance of prequalification status
UNFPA only procures male latex condoms and IUDs that have successfully completed all stages in the respective WHO/UNFPA Prequalification Schemes. Therefore, only manufacturers that are WHO/UNFPA prequalified may respond to tenders for UNFPA long term agreements to supply these commodities. Suppliers who are interested in beginning the prequalification process should review the publications Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 and TCu380A Intrauterine Contraceptive Device (IUD): Specification, Prequalification and Guidelines for procurement, 2010. A Step-by-Step summary of the prequalification process for all male latex condoms and IUDs can be found by clicking here.
Why is prequalification so important?
According to WHO, “international pharmaceutical norms and standards are more important than ever before, since they serve as global tools aiming to ensure safety and quality”. This is particularly important in the case of condoms and IUDs, as faulty products fail to provide adequate protection and can quickly destroy the credibility of any contraceptive promotion programme.
The Prequalification Scheme has been accordingly developed to ensure that:
- Products are safe and effective throughout their stated shelf lives.
- Manufacturers have effective quality management systems.
- Condoms and IUDs are tested to meet requirements of product standards.
- Manufacturers are physically able to deliver the required quantities of RH products.
- Enhance confidence in ability of manufacturers to meet all requirements and reduce the level of associated risk. Time and resource are saved in finding suitable suppliers.
A list of condom and IUD manufacturers pre-qualified under WHO/UNFPA prequalification programme is maintained by UNFPA and available here:
Prequalification has become increasingly widespread in international development and public health initiatives. The Global Fund, Roll Back Malaria Partnership, Stop TB, Partnership, Clinton Foundation, World Bank and various UN agencies have all recognized the importance of prequalifying suppliers, and they have instituted programs to meet this need.
You can read more about UNFPA quality assurance of male latex condoms and IUDs by clicking here.