Update to IPC on MODEL QUALITY ASSURANCE SYSTEM FOR PROCUREMENT AGENCIES (MQAS) Dr Sabine Kopp 16 December 2014 Update to IPC on MODEL QUALITY ASSURANCE.

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