UNDP’s approach

Upon governments’ requests, UNDP can provide support for identifying and assessing health products in accordance with World Health Organization (WHO) and international standards. It can also mobilize a pool of international experts to assist the regulatory authorities in the identification, assessment and prequalification of health products, in accordance with WHO and international standards. The same experts can be mobilized to provide training sessions in quality assurance to counterparts (regulatory authorities or central medical stores) in countries based on specific requests submitted by the authorities.

UNDP also provides support to the development of infrastructure and capacities in national quality control laboratories in several countries, in close collaboration with the WHO prequalification programme for quality control laboratories. In order to ensure that the quality of health products is maintained in the supply chain, UNDP also promotes the use of appropriate vehicles and containers for the transport of health products and the use of data loggers for controlling the storage and distribution of medicines. This implies the training of staff on the use, collection and analysis of data.

Tools and guidance

The health procurement performed by UNDP for donor grants complies with quality assurance policies established by the donor for specific health product categories. For other health product categories and for government-funded health procurement, UNDP has defined its own quality assurance policy for health products for medicines, medical devices including diagnostic products and personal protective equipment (PPE). The UNDP QA policy is based on WHO norms and standards and is aligned with the policies of other key stakeholders (the Global Fund to Fight AIDS, Tuberculosis and Malaria, the United Nations Children’s Fund – UNICEF, the United Nations Population Fund – UNFPA, Doctors Without Borders – MSF, International Committee of the Red Cross – ICRC, etc.).

UNDP has also developed a quality assurance planning tool, to help to carry out assessments at the country level throughout the supply chain cycle. This includes looking at all the aspects in the procurement and supply chain management (PSM) cycle that relate to ensuring the quality of the medicines and health products, from selection to use and waste management. The application of this tool is designed to be carried out in coordination with the national regulatory authority, WHO and other partners involved in health PSM in the country. The end result is the identification of gaps and the definition of activities to address and prioritize the identified needs, coordination of financial resources, and elaboration of an operational plan to strengthen the quality assurance in the national supply chain.

UNDP support to quality assurance: country examples

Zimbabwe obtained prequalification status from the World Health Organization (WHO) for its chemical laboratory to perform quality control (QC) in 2014 and it is in the process of getting its microbiology laboratory WHO-prequalified. UNDP is also supporting Sudan and Afghanistan to upgrade their QC laboratories to meet the WHO prequalification status.

In Kyrgyzstan and Uzbekistan, UNDP supported the national regulatory authority laboratories in assessment of their readiness to be included on the list of QC laboratories meeting requirements from the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) (ISO/IEC 17025) as well as in submission of questionnaires on the technical proficiency of QC drug testing laboratories for the Global Fund attestation. Both laboratories have been included in the list of ISO 17025 QC laboratories compliant with the Global Fund quality assurance requirements.

In Zimbabwe, UNDP is also providing support to the national regulatory authority to address the priorities identified in the institutional development plan developed jointly with WHO. UNDP plans to provide further support on the development of quality assurance systems in national procurement agencies.