Update to IPC on MODEL QUALITY ASSURANCE SYSTEM FOR PROCUREMENT AGENCIES (MQAS)
Dr Sabine Kopp16 December 2014
Update to IPC on MODEL QUALITY ASSURANCE SYSTEM FOR PROCUREMENT AGENCIES (MQAS)
Dr Sabine Kopp16 December 2014
MODEL QUALITY ASSURANCE SYSTEM FOR PROCUREMENT AGENCIES (MQAS)MODEL QUALITY ASSURANCE SYSTEM FOR PROCUREMENT AGENCIES (MQAS)
WHO Expert Committee on Specifications for Pharmaceutical Preparations of the World Health Organization (WHO) adopted in 2005 (Ref: Annex 6 in the Technical Report Series, No. 937 in 2006)
Procurement organizations have implemented the recommendations presented in the MQAS
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
MQASMQAS
Subsequently adopted as Interagency guideline by:
UNICEF
UNDP
UNFPA
World Bank
WHO
New developments since August 2011New developments since August 2011
Based on implementation -> Identification of need for revision and the need for an Assessment Tool for procurement agencies during meeting organized by WHO/The Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM)
Two informal meetings held by the Global Fund to prepare the new Assessment Tool and to review the MQAS; active Working Group created to develop a harmonized Assessment Tool
Working group members Working group members
Representatives from: - 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), - United States Agency for International Development (USAID) and -WHO
Progress during 2012 and 2013Progress during 2012 and 2013
Endorsement of revision process by 47th WHO Expert Committee on Specifications for Pharmaceutical Preparations
Review of comments received during circulation and during the Expert Committee meeting, in meeting of the Working Group (WG), preparation of revised MQAS
Informal consultation coorganized by GFATM and WHO’s Quality Assurance Programme: MQAS revision and aide-memoire, model inspection report and self-inspection tool reviewed, newly revised working documents prepared based on discussion and feedback by GFATM and WG
Revision Process +Revision Process +
The revision process of MQAS has resulted in the following :
newly proposed revised text of the MQAS (QAS/12.508/Rev.1);
a revised Product Questionnaire (QAS/13.556);
an Assessment Tool (QAS/13.558), together with
an Inspection report format (QAS/13.557);
an aide-memoire for the inspection (QAS/13.555).
Next stepsNext steps
Public consultation: http://www.who.int/medicines/areas/quality_safety/quality_assurance/projects/en/index.html
Presented to 48th WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) for possible adoption (14-18 October 2013)
4 new texts adopted by ECSPP
"Ready for use"
WHO Governing bodies (EB)…48th WHO Expert Committee on Specifications for
Pharmaceutical Preparations (TRS 986) – in May 2014
WHO Governing bodies (EB)…48th WHO Expert Committee on Specifications for
Pharmaceutical Preparations (TRS 986) – in May 2014
WHO TRS 986 WHO TRS 986
Annex 3 - Model quality assurance system for procurement agencies, including 2 new appendices:
– a revised model inspection report and – a revised interagency product questionnaire
Annex 4: Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection
French translation in preparation for e-publication!
MQAS what does it cover? MQAS what does it cover?
Module I: General requirements for procurement agencies
Module II: Prequalification
Module III: Purchasing
Module IV: Receipt and storage of purchased products
Module V: Distribution
Module VI: Reassessment
Annexes
MQAS: a comprehensive publicationMQAS: a comprehensive publication
Annex 1. Example of a code of conduct
Annex 2. Example of a guideline on confidentiality
Annex 3. Example of a guideline on conflict of interest
Annex 4. Example of a standard operating procedure (SOP) for writing an SOP
Annex 5. Example of an invitation for expression of interest
Annex 6. Interagency finished pharmaceutical product questionnaire (revised as "interagency")
Annex 7. Example of a standard operating procedure for screening and assessing product information
Annex 8. Quality systems recommendations for pharmaceutical inspectorates
Annex 9: Technical questionnaire for pharmaceutical manufacturers
Annex 10. Example of a standard operating procedure for planning of inspections
Annex 11. Example of a standard operating procedure for preparing for an inspection
Annex 12. Example of a standard operating procedure for performing an inspection
Annex 13. Example of a checklist for good manufacturing practices
Annex 14. Guidance on good manufacturing practices: inspection report (revised)
Annex 15. Good storage practice
Annex 16. Good trade and distribution practices (update in pipeline)
Annex 4: Assessment tool : aide-memoire for inspection Annex 4: Assessment tool : aide-memoire for inspection
Purpose
Harmonized tool to result in better use of resources by coordinating procurement agency (PA) assessments towards mutual recognition of the findings
Scope
Assessment tool is based on the six modules in the MQAS
Annex 4: Assessment tool : aide-memoire for inspection Annex 4: Assessment tool : aide-memoire for inspection
Assessment tool
Should be used by qualified, experienced persons when assessing a PA (including wholesalers and distributors) for compliance with recommended international standards
Can also be useful for a PA in self-assessment
Is not a checklist, but serves as a document to help and remind inspectors as to what should be assessed during inspections of PAs
Example (extract)Example (extract)
A harmonized self-assessment tool for procurement agencies
A harmonized self-assessment tool for procurement agencies
Working group developed also a harmonized compliance self-assessment tool based on the six MQAS modules
Evaluation includes % ratings allocated to 137 items
Tool supplements the formal WHO guidance texts by providing a consistent, flexible way to measure implementation of principles defined in MQAS
Tool enables to communicate outcomes in a standardized way, and to take targeted measures for improvement
Ref: WHO Drug Information Vol. 28, No. 4, 2014, p.434-447
Outline of 137 itemsOutline of 137 items
Rating of implementation/compliance Rating of implementation/compliance
0% No compliance, or the system/procedure does not exist
20% Very low level of compliance or implementation
40% Low level of compliance or implementation
60% Medium level of implementation (e.g. procedures have been developed, but lack scope and depth)
80% A good level of compliance
100% Fully implemented and consistently complies with MQAS expectation
Example of items assessed Example of items assessed
Model report formatModel report format
Future stepsFuture steps
New MQAS and assessment tools are "Ready for use" by procurement agencies and national/regional authorities
IPC/Agencies may envisage updating the interagency guidelines publication
http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/
http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en/
Safe quality medicines