Quality assurance (QA)
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The quality of health products has to be ensured from manufacturing up to the point of use. Quality Assurance is an overarching element to the whole PSM cycle beyond the prequalification of health products meeting WHO and national standards. Transportation, storage, distribution and use conditions impact the quality of health products.
Quality assurance is a wide-ranging concept covering all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that pharmaceutical products are of the quality required for their intended use. WHO definition
“Prequalification: The activities undertaken in defining a product or service need, seeking expressions of interest from enterprises to supply the product or service, and examining the product or service offered against the specification and the facility where the product or service is prepared against common standards of good manufacturing practice (GMP). Prequalification is required for all pharmaceutical products regardless of their composition and place of manufacture/registration.“ WHO definition
“Quality control covers all measures taken, including the setting of specifications, sampling, testing and analytical clearance, to ensure that starting materials, intermediates, packaging materials and finished pharmaceutical products conform with established specifications for identity, strength, purity and other characteristics.” WHO definition
UNDP developed its own QA policy for health products. UNDP QA policy is based on WHO norms and standards and is aligned with the policies of other key stakeholders (the Global Fund, UNICEF, UNFPA, MSF, ICRC, etc.).
Upon governments’ requests, UNDP can provide support for identifying and assessing health products in accordance with WHO and international standards.
UNDP is providing support to the development of infrastructure and capacities in national quality control laboratories in several countries, in close collaboration with the WHO prequalification (PQ) programme for Quality Control Laboratories (QCL).
Zimbabwe obtained WHO PQ status 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 (NRA) laboratories in assessment of their readiness to be included on the list of QC laboratories meeting Global Fund requirements (ISO/IEC 17025 i) as well as in submission of questionnaires on the technical proficiency of quality control 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 QA requirements.
In Zimbabwe, UNDP is also providing support to the NRA 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.
In ensuring that the quality of health products is maintained in the supply chain, UNDP is also promoting the use of data loggers for storage and distribution of medicines. This implies training of staff on their use, collection and analysis of data.
UNDP can mobilize a pool of international experts to assist the regulatory authorities in the identification, assessment and prequalification of quality health products.
The same experts can be mobilized to provide training sessions in QA to counterparts (regulatory authorities or central medical stores) in countries based on specific requests submitted by the authorities.
The UNDP tool, Quality Assurance Plan, is being developed to help to carry out assessments at country level throughout the supply chain cycle, from selection to use and waste management, all the aspects in the PSM cycle that relate to ensuring the quality of the medicines and health products.
The application of this tool is designed to be carried out in coordination with the NRA, 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.
The health procurement performed by UNDP for donor grants complies with QA policies established by the donor for specific health product categories. For other health product categories and for government-funded health procurement, UNDP has defined a QA policy for medicines, diagnostics, and medical devices.
In this section you can find guidance material related to quality assurance of health products.
Countries can also benefit from WHO programmes and tools for strengthening NRA functions, as well as for enabling and speeding up registration of WHO-prequalified and Stringent NRAs-registered medicines:
WHO has also established general requirements for quality assurance systems for procurement agencies to ensure that transactions with partners ultimately result in procuring health products of the best possible quality:
A Quality Control Laboratory prequalification has been established by WHO to enhance in-country capacities for quality control of medicines:
The following websites relate to major WHO and UN programmes for the prequalification of health products. The WHO quality assurance standards defined for each category of health products can be sourced through these websites.