TRS 986 - Annex 3: WHO model quality assurance system for procurement agencies

Background

The Expert Committee on Specifications for Pharmaceutical Preparations of the World Health Organization (WHO) adopted a Model quality assurance system for procurement agencies (MQAS) during a meeting in Geneva, Switzerland in 2005. This was subsequently published as Annex 6 in the Technical Report Series, No. 937 in 2006. Some procurement organizations have implemented the recommendations presented in the MQAS. Some donor organizations (including the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)) have endorsed the MQAS as part of their quality assurance policy for the procurement of pharmaceutical products with their funds. Several organizations have also prepared a tool to assess procurement agencies to establish the level of implementation and compliance with the MQAS.

Participants at a WHO/GFATM joint stakeholders meeting on Quality Assurance for Essential Medicines held in August 2011 in Geneva agreed that a working group consisting of representatives from the Committee for Medicinal Products for Human Use (CHMP), Crown Agents, Global Drug Facility (GDF), International Committee of the Red Cross (ICRC), International Development Association (IDA), Médecins Sans Frontières (MSF), Management Sciences for Health (MSH), Partnership for Supply Chain Management (PFSCM), Quality Medicines for All (QUAMED), International Union Against Tuberculosis and Lung Disease (The Union), United Nations Children’s Fund (UNICEF), United Nations Office for Project Services (UNOPS), and the United States Agency for International Development (USAID), be created to develop a harmonized Assessment Tool that could be used by all with the aim of better use of resources by coordinating procurement agency assessments and working towards mutual recognition of procurement agency assessment findings, and to participate in the revision of the MQAS.

The Global Fund Secretariat contracted a consultant through a competitive process in 2012 to review the existing MQAS and to make recommendations to WHO (in case the need was identified to change or update the MQAS), to review tools used by procurement agencies in the light of the existing MQAS and to prepare a harmonized tool for the assessment of procurement agencies, based on the MQAS, through a consultative process. Four informal meetings were also held at the Global Fund between 2012 and 2013 to discuss the MQAS, the comments, the draft tool, progress made and the way forward.

Since the first publication of the MQAS and its use by many organizations, it appeared that a revision would be timely and could include current developments. A first proposal for revision of the MQAS was presented at the forty-seventh meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, in Amsterdam,  Netherlands. The recommendations included in the report (WHO Technical Report Series, No. 981) of the fortyseventh meeting of the Expert Committee read as follows  (excerpt):

8.1 Revision of model quality assurance system for procurement agencies The model quality assurance system (MQAS) for procurement agencies was adopted by the Expert Committee in October 2005, since when it has been used by many organizations. … The revised MQAS and the proposed assessment tool were … circulated for comment in August 2012 by WHO following the usual Expert Committee consultation process. Comments were collated and the draft revised MQAS and the comments were presented to the Expert Committee for consideration. The Expert Committee considered the comments and proposed a number of amendments to the draft. The Expert Committee endorsed the proposal for a revision of the MQAS, and noted progress made to date.

8.2 Assessment tool based on the model quality assurance system
In August 2011, WHO and GFATM identified the need for a new assessment tool for procurement agencies in conjunction with the revision of the MQAS. The proposed assessment tool was based on the MQAS. A draft of the proposed tool was prepared during 2012 and was circulated for comment. The draft was being tested in a pilot process from August to December 2012, after which it would be further reviewed and revised according to the experience gained.

During 2012 the draft assessment tool was used in a pilot phase (July to December 2012) by different organizations procuring medicines. Comments received on the MQAS as well as additional comments based on the use of the draft assessment tool (to assess procurement agencies) were reviewed during a meeting of the working group arranged through the Global Fund, on 7 and 8 February 2013, at the Global Fund offices in Geneva.

The fourth informal consultation was held in June 2013 to discuss additional comments on the MQAS as well as the newly developed aide-memoire to be used in assessing procurement agencies. The objective of the revised MQAS and use of an aide-memoire is to promote and ensure that all procurement agencies follow the same standard. A model format for an inspection report was prepared. The product questionnaire was reviewed.

During its forty-eighth meeting, the WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted the updated MQAS together with the replacement texts for Appendix 6 Interagency finished pharmaceutical product questionnaire and Appendix 14 Guidance on good manufacturing practices: model inspection report. In addition, the aide-memoire was recommended for use and is published as Annex 4 in the report of the fortyeighth Expert Committee meeting (WHO Technical Report Series, No. 986).