Skip to main content

Home

Home

AMRH Site Header Menu

  • Home
  • Who We Are
  • Our Focus
    • African Medicines Agency
    • AMRH Technical Committees
      • ABRF TC
      • AVAREF-TC
      • AMDF-TC
      • AMQF
      • IMS-TC
      • EMP-TC
      • GMP TC
      • MPRR-TC
      • RCD-TC
    • RCOREs
    • AMRH Partnership Platform
  • What We Do
  • Resources
    • FRPath® Project.
SEARCH BY
Good Manufacturing Practices Technical Committee (GMP TC)
  • Vision
  • Mission
  • Purpose
  • Scope of Work
  • Objectives
  • Leadership
  • Partners

Vision

To lead and spearhead building and strengthening of  GMP inspections capabilities to AU Member States in collaboration with RECs, pharmaceutical industry, and partners in attaining acceptable maturing for GMP standards in Africa.

Mission

To protect Africa’s public health through ensuring that medicines including vaccines circulating on African markets are manufactured in compliance with internationally acceptable standards of GMP.

Purpose

Established to assist AU Member States to build their GMP capabilities, provide technical advice on the development and implementation of sustainable GMP Standards in collaboration with RECs, pharmaceutical industry, and partners in support of the AU PMPA and PAVM through the AMRH Initiative and eventually AMA once operational.

Scope of Work

Work with AU member states through RECs MRH programs and respective NRAs to develop or establish and enforce requirements for GMP standards in Africa

Objectives

 

  1. Develop harmonized technical guidance and procedures as reference for cGMP inspections across the African continent within the context of the continental GMP Framework.
  2. Support development and implementation of AMA’s cGMP procedures and inspections program for its scope of products including vaccines, biologicals, biotherapeutic products, radiopharmaceuticals, amongst other complex products outlined in AMA’s scope.
  3. Provide a forum to accelerate attainment of international GMP Standards by local pharmaceutical manufacturers in Africa through provision of recommendations, guidance and support.
  4. Identify best practices and lessons learned to support RECs in developing strategies and approaches for attainment of international GMP Standards by local pharmaceutical manufacturers in Africa.
  5. Identify partners, resources, and tools to promote attainment of GMP international standards by local pharmaceutical manufacturers in Africa.
  6. Identify existing and innovative GMP Certification Schemes for piloting and eventual continental scale up.
  7. Support PAVM to facilitate GMP inspection of vaccines manufacturing sites to ensure excellence in vaccines regulatory oversight.
  8. Identify training needs and develop certified training programmes for inspectors in collaboration with Regulatory Capacity Development Technical Committee (RCD- TC).
  9. Support attainment of accreditation by NRAs through international schemes and standards such as PIC/s, WHO Global Benchmarking Tool e.t.c.
  10. Development of shared platform which will be used by all partner/member states to share information.

Leadership

Mr. Wayne Muller
Chair Person

Head of Inspectorate, SAHPRA, South Africa

Mr. Madicke Diagne
The Vice Chairperson

Inspector, ARP, Senegal

Partners

Bill & Melinda Gates Foundation
CEPI
International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)
Swissmedic
UNITAID
United States Pharmacopeia (USP)

Load More

AMRH Site Header Menu

  • Home
  • Who We Are
  • Our Focus
  • What We Do
  • Resources

CONNECT WITH US

Copyright © 2022 African Union Development Agency (AUDA-NEPAD). All rights reserved. | Terms & Conditions | Fraud Alert