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 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”.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 functions

IPC meeting June 2014 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** principles Quality Monitored all along the supply chain Antiretrovira lanti-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 48 th WHO Expert Committee on Specifications for Pharmaceutical Preparations for possible adoption (14-18 October 2013)

IPC meeting June th 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 III Module IV Module V Module VI PrequalificationPurchasingReceiving 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 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