Materials are available for download
PATH recently held workshops, in collaboration with the World Health Organization (WHO) and the United Nations Population Fund (UNFPA), to help purchasers and suppliers make use of the WHO prequalification program. Find out more about the prequalification program on WHO's website.
Workshops for procurement professionals
PATH, WHO, and UNFPA conducted two regional workshops for national procurement entities: in Senegal for West African participants (December 2007) and Nicaragua for Central American participants (January 2008). These regions were selected to reflect a shift from donor-provided reproductive health (RH) supplies (contraceptives, in particular) to greater national government responsibility and recent efforts to unify systems across countries. In the case of Central America, these efforts include regional drug regulation; in West Africa, an informed buying network consisting of several countries.
The overall objective of the procurement workshops was to provide knowledge and skills to procurement professionals, enabling them to effectively use the prequalification program. The workshops consisted of educational and skills-building components to convey:
- The benefits of prequalification within the procurement context.
- How to effectively incorporate prequalification into bidding documents and bidder assessments.
The workshop content was developed for individuals working at national levels to manage procurement or related quality assurance processes for RH medicines. Participants were representatives from national procurement, pharmacy, and regulatory agencies who are directly involved in procurement decisions for RH commodities and in ensuring high-quality medicines in their country. Participants were assumed to be familiar with donor-funded procurement and regulatory requirements as well as requirements in a specific country or region.
The presentations from the workshop are available for download. If the presentations are adapted for a workshop, PATH recommends that facilitators experienced in the subject matter manage each session.
Workshops for manufacturers of latex male condoms
PATH, WHO, and UNFPA conducted three-day workshops in January and February 2008 in Beijing, Bangkok, and New Delhi for manufacturers of latex male condoms to introduce and solicit input on the new prequalification program for male condoms. The aim was to increase the successful participation of manufacturers in the new WHO/UNFPA prequalification scheme. In total, representatives of 40 manufacturers from eight countries (Botswana, China, India, Korea, Malaysia, South Africa, Thailand, and Vietnam) attended the workshops.
The workshop objectives were to introduce and solicit input on:
- Advantages of participation and the prequalification process.
- International Organization for Standardization (ISO) and WHO requirements as applied in the prequalification process.
- Documents required to apply for prequalification, including the site master file and product dossier.
- Site inspection procedures.
In addition, the second day of the workshop was devoted to in-depth technical issues, namely standards, shelf-life determinations, safety, and statistical quality control.
The prequalification scheme is intended for primary manufacturers of latex male condoms who undertake the processes of formulation, compounding, and dipping, as well as for manufacturers using prevulcanized latex. The prequalification scheme does not apply to agents or suppliers engaged only with condom testing and packaging or with nonlatex products.