Model Quality Assurance System for procurement agencies. What it means for manufacturers?

Transcription

1 Model Quality Assurance System for procurement agencies. What it means for manufacturers? JOINT UNICEF, UNFPA & WHO MEETING WITH MANUFACTURERS AND SUPPLIERS OF DIAGNOSTIC PRODUCTS, FINISHED PHARMACEUTICAL PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS September 2013 Dr Joelle DAVIAUD, Quality Assurance Specialist

2 OUTLINE Background MQAS use Structure Benefits

3 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

4 Background 2005: The Expert Committee on Specifications for Pharmaceutical Preparations of the World Health Organization (WHO) adopted a Model Quality Assurance System for Procurement Agencies (MQAS) 2006: published as Annex 6 in the Technical Report Series, No : partners working group QUAMED, PFSCM, UNICEF, MSF, IDA, Crown Agents, GDF, MSH, UNION, UNOPS, USAID, ICRC and CHMP was created to review the MQAS document and develop a harmonized assessment tool. 2013: revision submitted to Expert Committee for adoption

5 MQAS use Some procurement organizations have implemented the recommendations presented in the MQAS. Some donor organizations endorsed the MQAS as part of their quality assurance policy for the procurement of pharmaceutical products with their funds. 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

6 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 1- Prequalification of products and manufacturers 2- Purchase 3- Storage 4- Distribution

7 Category Antiretrovira lanti-tb, antimalarial (ATM) medicines Global Fund Current approach to QA of grant-funded medicines WHO-PQP prequalified SRA Registered ERP Time-limited approval (if <2 WHO- PQP/SRA:) National Medicines Regulatory Authority (NMRA) approval Procurement as per WHO- MQAS** principles Quality Monitored all along the supply chain Other essential medicines * WHO-PQP: WHO Prequalification Programme ** WHO MQAS: WHO Model Quality Assurance System for procurement agencies

8 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

9 Module II Module III Module IV Module V Module VI Prequalification Purchasing Prequalification procedure EOI Product information, screening and evaluation Inspections Purchasing Monitoring of performance of prequalified manufacturers Receiving and dispatch Receiving Quality control Storage Stock control Distribution of purchased products (Packaging transport) Containers and labelling Dispatch Transport Transit Re-assessment Re-assessment of manufacturers Re-evaluation of products Monitoring of contracted-out services Prequalification outcome

10 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

11 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

12 Harmonised Tool for Assessment of PA Harmonized tool developed by partners and PAs to align the assessment criteria Submitted to WHO Expert Committee in October 2013 for discussion/ approval? Tool can be used by PA for self assessment 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

13 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

14 WHO guidance: urance/guidelines/en/index.html see under "Current projects" (MQAS is under revision) THANK YOU