GDF Quality Assurance Processes

The products GDF procures are subject to the following Quality Assurance criteria: Manufacturers' compliance with WHO/GMP standards as assessed under the TB Prequalification Project. GMP

Product Compliance: Option I Product compliance with either: Option (I): WHO-recommended standards for medicines as assessed under the aforementioned WHO/PSM Procurement, Quality and Sourcing Project: Access to Anti-Tuberculosis Drugs of Acceptable Quality i.e. Product is Prequalified Product Compliance: Option I

Product Compliance: Option II Option (II): compliance with the assessment criteria as determined by WHO/PSM & product dossiers are assessed against these criteria by an ad hoc transparent, independent expert committee convened by WHO/PSM at the request of GDF. The ad hoc committee is drawn from the same team of evaluators who assess product dossiers for quality aspects and for efficacy and safety (or bio-equivalence) under the TB Prequalification Project. Product Compliance: Option II

All batches of all products procured by GDF, irrespective of whether product compliance falls under option I or option II, are subject to independent quality control testing by a laboratory that: (a) is from a country that is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) (b) from a country that is party to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) or (c) has been assessed by WHO PSM/QSM and found to meet recommended international norms and standards for the analysis of products Quality Control

Implications for GFATM PRs GDF adheres to GFATM compliance list GDF adheres to its own QA criteria in addition to the GFATM compliance list After next GDF tender in Q2/Q3 2006, for GDF QA criteria GDF will limit procurement to suppliers under GDF Option I where 2 or more suppliers are available under this option Implications for GFATM PRs

For more information on TB Prequalification, please refer to the Global Drug Facility web-site: www.stoptb.org/GDF or the WHO website at www.who.int /medicines Or contact, via electronic mail: GDF.PRS@stoptb.org doucelinc@who.int griffing@who.int Contact Information

Summary Please make provision in proposals to GFATM or reprogramming of approved proposals to improve quality assurance: Identify gaps, select items to address short term / medium term Ensure PRs adhere to GFATM compliance list In general advise procurement from Quality Assured sources only: WHO List, GDF, GLC, GFATM List, MSF, UNICEF, IDA