IPC meeting June 2014 Dr Joelle DAVIAUD, Quality Assurance Specialist Model Quality Assurance System for procurement agencies.

IPC meeting June 2014

Dr Joelle DAVIAUD, Quality Assurance Specialist

Model Quality Assurance System for procurement agencies .

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

Good Procurement PracticesPrincipal 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 manufacturers2- Purchase

3- Storage 4- Distribution

4 Critical

functions

IPC meeting June 2014

Global Fund Current approach to QA of grant-funded medicines

Category

WHO-PQP

prequalified

SRA

Registered

ERPTime-limited

approval

National Medicines Regulatory Authority (NMRA)

approval

Procurement as per WHO-

MQAS** principles

Quality Monitored all

along the supply chain

Antiretroviralanti-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 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 thereWhich 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 AgenciesOrganization and managementPersonnel Quality systemsDocumentationCounterfeit productsSelf-inspectionComplaintsRecalls6 Modules

IPC meeting June 2014

Module II

Module III

Module IV

Module V

Module VI

Prequalification Purchasing Receiving and dispatch

Distribution of purchased products (Packaging – transport)

Re-assessment

Prequalification procedure

EOI

Product information, screening and evaluation

Inspections

Prequalification outcome

Purchasing

Monitoring of performance of prequalified manufacturers

Receiving

Quality control

Storage

Stock control

Containers and labelling

Dispatch

Transport

Transit

Re-assessment of manufacturers

Re-evaluation of products

Monitoring of contracted-out services

IPC meeting June 2014

Products questionnairePublished 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 UNIONGDF/ Global Fund for dossier submission to ERP