Update to IPC on MODEL QUALITY ASSURANCE SYSTEM FOR PROCUREMENT AGENCIES (MQAS) Dr Sabine Kopp 18 June 2015
Update to IPC on
MODEL QUALITY ASSURANCE SYSTEM
FOR PROCUREMENT AGENCIES (MQAS) Dr Sabine Kopp
18 June 2015
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
New 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
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 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 +
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 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 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 now available (e-publication)!
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 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 progress)
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
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
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
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
Set of tools available
Model quality assurance system for procurement agencies,
published in TRS 986 as Annex 3 - including 2 new appendices:
– a revised model inspection report and
– a revised interagency product questionnaire
Assessment tool based on the model quality assurance system
for procurement agencies: aide-memoire for inspection ,
published in TRS 986 as Annex 4
French translation of the main MQAS and the assessment tool (e-
publication)
A harmonized self-assessment tool for procurement agencies
published in WHO Drug Information Vol. 28, No. 4, 2014, p.434-447
Next steps
New MQAS and assessment tools are
"Ready for use" by procurement agencies
and national/regional authorities
Training taking place, e.g. by QUAMED
Question: IPC/Agencies to agree to adopt as
Interagency guidelines publication to replace
the 2007 version ?