1. No category

Model Quality Assurance System for
procurement agencies .
Dr Joelle DAVIAUD,
Quality Assurance Specialist
IPC meeting June 2014
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
IPC meeting June 2014
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
IPC meeting June 2014
Quality Assurance for Health Products
To ensure safe, effective health products and
acceptable to end users.
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”.
4
Critical
functions
IPC meeting June 2014
1- Prequalification of products and manufacturers
2- Purchase
3- Storage
4- Distribution
Global Fund Current approach to QA
of grant-funded medicines
Category
WHO-PQP
SRA
ERP
prequalified Registered Time-limited
approval
National
Medicines
Regulatory
Authority
(NMRA)
approval








Antiretrovira
lanti-TB,
antiMalarial
(ATM)
medicines
(if <2 WHOPQP/SRA:)
Procurement
Quality
as per WHO- Monitored all
MQAS** along the supply
principles
chain

Other
essential
medicines
* WHO-PQP: WHO Prequalification Programme
** WHO MQAS: WHO Model Quality Assurance System for procurement agencies
IPC meeting June 2014
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 Fund
IPC meeting June 2014
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)
IPC meeting June 2014
48th WHO Expert Committee on Specifications for Pharmaceutical
Adopted in May 2014
IPC meeting June 2014
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 ressources
IPC meeting June 2014
MQAS benefits (2)
Harmonized Tool for Assessment of PA to align the assessment criteria: 2
main applications
• Tool 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 assessments
Harmonized tools are there
Which system can be put in place to set up this independent PA assessment?
What about an ERP like mechanism?
IPC meeting June 2014
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 processes
IPC meeting June 2014
Thank you
IPC meeting June 2014
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-inspection
Complaints
Recalls6 Modules
IPC meeting June 2014
Module II
Module IV
Module V
Prequalification Purchasing
Receiving and
dispatch
Distribution of Re-assessment
purchased
products
(Packaging –
transport)
Prequalification
procedure
Receiving
Containers and
labelling
EOI
Product
information,
screening and
evaluation
Inspections
Prequalification
outcome
IPC meeting June 2014
Module III
Purchasing
Monitoring of Quality control
performance of
prequalified
Storage
manufacturers
Stock control
Module VI
Re-assessment
of
manufacturers
Dispatch
Transport
Transit
Re-evaluation of
products
Monitoring of
contracted-out
services
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 status
• FFP 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
IPC meeting June 2014