Model Quality Assurance System for procurement agencies MQAS Goal and objectives This Model is intended to assist organizations purchasing pharmaceutical products vaccines or other health sector goods or which ID: 749680
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Slide1
Dr Joelle DAVIAUD,
Quality Assurance Specialist
Model Quality Assurance System for
procurement
agencies
.
Slide2
MQAS: Goal and objectives
“
This Model is intended to assist organizations purchasing pharmaceutical products, vaccines, or other health sector goods or which are otherwise involved in the prequalification, purchasing, storage and distribution of
such products, hereafter referred to as procurement agencies,
to procure
safe,
effective
pharmaceuticals of suitable
quality” (
MQAS)
2000: clear need
identified by WHO and partners for establishing
, harmonizing and implementing a
quality assurance system
for
prequalification
purchasing
storage
distribution
of
pharmaceuticals/diagnostics/ health goods Slide3
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
fundsSlide4
Quality Assurance for Health Products
Good Procurement Practices
Principal Recipients must procure all products in accordance with principles set out in the interagency guidelines ( GF QA policy)
“
A Model Quality Assurance System for Procurement Agencies
”.
To ensure safe, effective health products and
acceptable to end users.
1- Prequalification of products and manufacturers
2- Purchase
3- Storage
4- Distribution
4
Critical functionsSlide5
Global Fund Current approach to QA
of grant-funded medicines
Category
WHO-PQP
prequalified
SRA
Registered
ERP
Time-limited approval
National Medicines Regulatory Authority (NMRA) approval
Procurement as per
WHO-MQAS**
principlesQuality Monitored all along the supply chainAntiretroviralanti-TB, antiMalarial (ATM) medicines(if <2 WHO-PQP/SRA:)Other essential medicines
*
WHO-PQP: WHO Prequalification
Programme
** WHO MQAS: WHO Model Quality Assurance
System for procurement agenciesSlide6
MQAS revision
Several
organizations prepared a tool to assess procurement agencies to establish the level of implementation and compliance with the MQAS.
no alignment of the evaluation material developed
2011
:
partners working group
QUAMED, PFSCM, UNICEF, MSF, IDA, Crown Agents, GDF, MSH, UNION, UNOPS, USAID, ICRC
CHMP, and WHO was created to review the MQAS document develop a harmonized assessment tool.
Three informal meetings held by the Global FundSlide7
Outcomes
The
revision process of MQAS has resulted in the following :
newly revised
text of the
MQAS
a
revised
Product Questionnaire
an
Assessment Tool, together with an Inspection report format; an aide-memoire for the inspection.
Adopted to 48th WHO Expert Committee on Specifications for Pharmaceutical Preparations for possible adoption (14-18 October 2013)Slide8
48
th WHO Expert Committee on Specifications for Pharmaceutical Adopted in May 2014
Slide9
MQAS benefits
Better understanding on Quality Assurance principles , good procurement practices, good distribution processes
Clear principles for “ prequalification “ of products not subject to WHO prequalification program or stringent quality criteria as per partners quality assurance policies
Clear principles identified to ensure procurement of products of assured quality , ensuring quality of products all along the procurement process: receipt, storage, distribution.
Principles used by PAs but also by Principle Recipients
Common product questionnaire dossier:
Harmonization
and consistency of the information provided by manufacturer
Same dossier can be sent to different
PAs: better use of the ressourcesSlide10
MQAS benefits (2)
Harmonized
Tool for Assessment of PA to align the assessment criteria: 2 main applicationsTool can be used by PA for self assessment
FEI project on reinforcement of Quality Assurance System in 11 National Procurement Agencies
Tool to be used by an
Independent Party to perform PA assessment Development
of the harmonized tool for assessment of PA based
, on
MQAS
principles, using transparent processes and common tool , should lead To work towards mutual recognition of PA assessment findings. To ensure better use resources by coordinating PA assessmentsHarmonized tools are thereWhich system can be put in place to set up this independent PA assessment
?What about an ERP like mechanism? Slide11
What it means for manufacturers
Clear information available to manufacturers on how to prequalified products, quality control performed, inspection criteria followed, expectations for transport conditions…
- manufacturers can build in advance the processes to comply with these requirements Common Product Dossier :all information submitted clearly defined , helping manufacturer to submit in one hand all the expected information
same dossier can be submitted to different PAs, facilitate the manufacturer work, no duplication of work
Site Inspection:
Based on clear principles and reference, PAs are working more and more developed joint on site inspection
Simplification of processesSlide12
Thank youSlide13
MQAS Structure :
A quality assurance system should be in place to ensure that transactions
ultimately result in procuring pharmaceutical products of the best possible quality. 6 modules:
Module I: General requirements for Procurement Agencies
Organization and management
Personnel
Quality systems
Documentation
Counterfeit products
Self-inspectionComplaintsRecalls6 ModulesSlide14
Module II
Module III
Module IV
Module V
Module VI
PrequalificationPurchasingReceiving and dispatchDistribution of purchased products (Packaging – transport)
Re-assessmentPrequalification procedure
EOI
Product information, screening and
evaluationInspectionsPrequalification outcomePurchasingMonitoring of performance of prequalified manufacturersReceiving Quality controlStorage Stock controlContainers and labellingDispatchTransportTransitRe-assessment of manufacturersRe-evaluation of productsMonitoring of contracted-out services Slide15
Products questionnaire
Published in annex of the MQAS in 2006
Model of questionnaire to be used by manufacturer when submitted information to Procurement agencies ( PA)Information requested Regulatory status/ GMP inspection statusFFP production/ Specifications/ Quality Controls
API regulatory status
Stability data
Packaging Information
Clinical Information/ BE studies
Today, unique /
harmonised
dossier used by WHO Procurement Departemnt/ UNICEF/ ICRC/ MSF/ The UNION GDF/ Global Fund for dossier submission to ERP