Stop TB Partnership

Quality Assurance Policy

GDF's Quality Assurance Principles:

With the mission of guaranteeing the safety, efficacy and quality of products1 provided by GDF, the quality assurance system is based on:

  • Recommendations by WHO / Stop TB Strategy
  • Authorization for use by recipient countries
  • Recommendations by the relevant WHO Programmes i.e., Prequalification of Medicines Programme (PQP); Prequalification of Diagnostics Programme; Performance, Quality and Safety for Therapeutic Devices.
  • Authorization for marketing in the country of manufacture by a Stringent National Medicines Regulatory Authority (SRA),
  • Recommendations for procurement purposes by an Expert Review Panel, for a specified time period where there are no WHO prequalified or SRA approved products available;
  • Monitoring programme of the quality of supplied products including independent random quality control and post-delivery surveillance.

To ensure global consistency on quality standards set for procurement and supply of anti-TB medicines, diagnostics and medical devices and to avoid duplication of product-supplier evaluations, GDF is working towards harmonization of policies and procedures and enhanced collaboration with the Global Fund and other partners.

Quality Criteria for Selection of anti-TB Medicines and Manufacturers:

To be eligible for GDF supply, any medicine and its manufacturing site must comply with GDF QA criteria established as follows:

  1. All finished pharmaceutical products (FPP) must be authorized by the relevant National Medicines Regulatory Authority (NMRA) in the country of use,
  2. Products shall be pre-qualified by WHO under the WHO PQP; or
  3. Products shall be approved by a SRA2
  4. In absence of products meeting the standards "2" and "3" above, products may be approved by GDF under the following option: Products shall be found acceptable to the GDF through a quality risk/benefit assessment process involving an Expert Review Panel (ERP). Products shall be eligible for this interim process under the following conditions:

    1. The FPP must be manufactured at an approved site as follows:

      • The site must have been inspected by WHO as a part of the WHO PQP (refer to http://apps.who.int/prequal/) and found to be operating at an acceptable level of compliance with WHO GMP for the specific product; or
      • The site must have been inspected and found acceptable for the manufacture of the specific product3 by SRA defined as either: an International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) member country, an ICH observer or any country whose regulatory authority is associated with an ICH member through a legally binding mutual recognition agreement4 ; or
      • The site must have been inspected and found acceptable for the manufacture of the specific product by inspectors of a regulatory authority participating in the Pharmaceutical Inspection Cooperation Scheme (PIC/S)5
    2. A product approval as described under either points "B" or "C" is pending, i.e. manufacturers have submitted relevant product dossiers and the dossiers have been accepted for assessment either by WHO PQP or SRA. Approvals under point "D" shall be limited to a maximum duration of 12 months in which manufacturers should obtain approval by WHO PQP or SRA.

Medicine Monitoring Programme:

GDF organizes independent pre-shipment inspection (PSI), sampling and testing of medicines through contracting of services to external Quality Control Agents (QCAs).

From March 2009, GDF is part of the Global Fund and partner's Quality Control Initiative, using same consignment inspection, sampling and testing capabilities and publishing jointly Request for Proposals for the selection of the common Quality Control Agents aimed at:

  • Harmonization of activities
  • Standardization of process and procedures
  • Cost efficiency through the pooling of activities and sharing of results
  • Transparency and competition

In July 2009, the Global Fund and GDF launched a RfP (Request for Proposal) for the selection of agents for the provision of the pre-shipment inspection, batch sampling and testing services.

For a product supplied to a country receiving financial support of the Global Fund, GDF coordinates the monitoring activities with the Global Fund in order to avoid duplication of PSI and quality control testing.

See full document GDF Quality Assurance Policy 2010 [.pdf]


1 Products include medicines, diagnostics and medical devices

2 SRA is defined as either: an International Committee on Harmonization (ICH) member country, an ICH observer or any country whose regulatory authority is associated with an ICH member through a legally binding mutual recognition agreement, or be approved or subject to a positive opinion under the Canada S.C. 2004, c. 23 (Bill C-9) procedure, or Art. 58 of European Union Regulation (EC9 No. 726/2004) or United States FDA tentative approval

3 Requirement fulfilled as long as the scope of the audit covers the specific product

4 International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use: www.ich.org a member of the ICH or (b) an ICH Observer, being the European Free Trade Association (EFTA) as represented by Swiss Medic, Health Canada and World Health Organization (WHO) (as may be updated from time to time); or (c) a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement including Australia, Norway, Iceland and Liechtenstein (as may be updated from time to time). For new EC members, like Cyprus, Lithuania, Malta, Poland and Latvia, GDF will consult with relevant WHO experts on the progress in adjusting their pharmaceutical legislation to EU laws before recognizing the approval by the national health authorities.

5 Pharmaceutical Inspection Cooperation Scheme: http://www.picscheme.org/. For any new PIC/s Member GDF will consult with relevant WHO experts on the level of equivalence of the GMP inspection level to those of old members PICs countries.

Iso

GDF is ISO 9001:2000 compliant for provision of quality-assured anti-TB drugs and related services to eligible national TB control programmes.