Quality assurance of health products

Purpose

The quality of health products has to be ensured from manufacturing up to the point of use. Quality assurance (QA) is an overarching element to the whole PSM cycle, beyond the prequalification of health products, to ensure compliance with WHO and national standards. Transportation, storage, distribution and use conditions impact the quality of health products.

Key concepts

Quality assurance

“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.” – World Health Organization

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.” – World Health Organization

Quality control

“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.” – World Health Organization

Pharmaceutical waste management

Pharmaceutical waste management is regarded to be an integral part of quality assurance within supply chain management and the product lifecycle, as a result of the use and/or expiry of health products. Inadequate and inappropriate handling of healthcare waste can have serious public and global health consequences and a significant impact on the environment. Refer to the Health care waste management page for further information.

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.

Key resources

UNDP Programme and Operations Policies and Procedures: Quality Assurance for Health Products
United Nations Development Programme
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Guide to Global Fund Policies on Procurement and Supply Management of Health Products
The Global Fund
Global Fund principles and standards related to quality assurance of health products are summarized in this booklet
[su_button url=”https://www.theglobalfund.org/media/5873/psm_procurementsupplymanagement_guidelines_en.pdf?u=636663947340000000″ target=”blank” background=”#0468b1″ color=”#1f0101″ icon=”icon: file-pdf-o” text_shadow=”0px 0px 0px #000000″]PDF[/su_button]

Global Fund Quality Assurance Policy for Diagnostics Products
The Global Fund
[su_button url=”https://www.theglobalfund.org/media/5885/psm_qadiagnostics_policy_en.pdf” target=”blank” background=”#0468b1″ color=”#1f0101″ icon=”icon: file-pdf-o” text_shadow=”0px 0px 0px #000000″]PDF[/su_button]

Global Fund Quality Assurance Policy for Pharmaceutical Products
The Global Fund
[su_button url=”https://www.theglobalfund.org/media/5898/psm_qapharm_presentation_en.pdf” target=”blank” background=”#0468b1″ color=”#1f0101″ icon=”icon: html5″ text_shadow=”0px 0px 0px #000000″]PDF[/su_button]

Regulatory System Strengthening
World Health Organization
Countries can benefit from WHO guidance and tools for strengthening national regulatory authority functions, as well as for enabling and speeding up registration of WHO-prequalified and stringent national regulatory authority-registered medicines.
[su_button url=”https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss” target=”blank” background=”#0468b1″ color=”#1f0101″ icon=”icon: html5″ text_shadow=”0px 0px 0px #000000″]Website[/su_button]

UNDP Quality Assurance Policy and Plan – UNDP-Global Fund and Health Implementation Guidance Manual
United Nations Development Programme
[su_button url=”https://undphealthimplementation.org/functional-areas/procurement-and-supply-management/undp-quality-assurance-policy-and-plan/” target=”blank” background=”#0468b1″ color=”#1f0101″ icon=”icon: html5″ text_shadow=”0px 0px 0px #000000″]Website[/su_button]

55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations
Relevant sections include:
Annex 9: Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce
Annex 10: Good reliance practices in the regulation of medical products: high level principles and considerations
Annex 11: Good regulatory practices in the regulation of medical products
[su_button url=”https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations” target=”blank” background=”#0468b1″ color=”#1f0101″ size=”2″ icon=”icon: file-pdf-o” text_shadow=”0px 0px 0px #000000″]PDF[/su_button]

WHO Collaborative Procedure for Accelerated Registration
World Health Organization
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:

WHO Model Quality Assurance System for Procurement Agencies (MQAS)
World Health Organization
[su_button url=”https://cdn.who.int/media/docs/default-source/medicines/norms-and-standards/guidelines/quality-control/trs986-annex3-who-model-quality-assurance-system-for-procurement-agencies.pdf?sfvrsn=275b3abc_2″ target=”blank” background=”#0468b1″ color=”#1f0101″ size=”2″ icon=”icon: file-pdf-o” text_shadow=”0px 0px 0px #000000″]PDF[/su_button]

WHO Prequalification of Quality Control Laboratories
World Health Organization
A quality control laboratory prequalification has been established by WHO to enhance in-country capacities for the quality control of medicines.
[su_button url=”https://extranet.who.int/pqweb/medicines/information/quality-control-laboratories” target=”blank” background=”#0468b1″ color=”#1f0101″ size=”2″ icon=”icon: html5″ text_shadow=”0px 0px 0px #000000″]Website[/su_button]

The following web pages relate to major WHO and United Nations 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:

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