UNDP Quality Assurance Policy

The UNDP Quality Assurance Policy for Health Products (QA Policy) was developed to assure the quality and safety of all health products procured and/or supplied by UNDP. The QA Policy is based on WHO norms and standards for medicines and other health products and is aligned with the QA policies of other UN agencies and international organizations.

The UNDP QA policy focuses on activities that must be built into the upstream Health Product Management (HPM) activites of selection, sourcing, procurement, pre-shipment inspection, sampling, quality control, and freight to ensure that the health products procured and/or supplied by UNDP meet the established minimum quality standards. However, the same principles which govern these upstream activities are applicable to activities which take place within countries, which ensures that products are supplied to recipients in accordance with the WHO norms and standards for health products.

Information contained within this section, together with the Guidance for UNDP Country Offices on Health Products Quality Assurance in the Supply Chain, should guide the downstream HPM activites that UNDP COs implement – directly, through SR agreements, or through service contracts – to maintain and control the quality of health products, from the delivery point in country up to the end user. It also covers aspects related to rational use, pharmacovigilance and pharmaceutical waste management. Such activities influence the quality of treatment, the safety for the patient and the community, while safe management of health products waste contributes to the protection of the environment.

Implementing activities in accordance with these requirements reduces the risk of introducing substandard or falsified products into the supply chain, which can put patients at risk and damage the reputation of UNDP. Accordingly, all UNDP business units are required to carry out health procurement in compliance with the UNDP QA Policy, which was approved by the Executive Group in July 2018 and included in the UNDP POPP.

The National (Drug) Regulatory Authority (NDRA) is the main actor for the regulation of health products in a country. The scope of operation of the NDRA is legislated and may only include pharmaceuticals, but increasingly NDRAs are also regulating medical devices. UNDP COs need to work closely with the NDRA to ensure that any action taken by the UNDP CO is in full compliance with the national regulations and policies.

The UNDP QA policy is independent from the Global Fund QA policies, and is broader than GF QA policies as it covers all types of medical products procured and supplied by UNDP (e.g., anti-cancer medicines, anti-diabetics, etc.). It is, however, aligned with GF QA policies and based on the same principles. Compliance with UNDP QA policy therefore ensures compliance with the GF QA policies.

UNDP COs are advised to designate one of the CO PSM officers as the Quality Assurance (QA) focal point for health products, tasked with ensuring that the CO operates in compliance with the UNDP QA policies and requirements for the procurement and supply management of health products.

[1] The WHO’s Model Quality Assurance Systems (MQAS) for Procurement Agencies, describes the key QA responsibilities for agencies engaged in procurement and supply chain management of health products. and is the main reference areas included in this Manual.