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

MQAS

Subsequently adopted 2007 as Interagency guideline by:

UNICEF

UNDP

UNFPA

World Bank

WHO

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

Example (extract)

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 items

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

Model report format

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 ?

http://www.who.int/medicines/areas/quality_safety/quality_assurance/distribution/en

/

Safe quality medicines