Ensuring quality of medicines procured with Global Fund resources HIV AIDS conference Satellite on Essential Medicines for HIV AIDS Mexico 6 August 2008

2 Introduction  The Global Fund is a financial institution, about 49% of grant funds are for medicines and health products procurement. ARVs purchase of in 2007: 65 % of expenditures for pharmaceuticals products, around 100 million US $  The GF does not conduct any procurement activities for pharmaceutical products  Global Fund Procurement Principles: To procure quality assured products at the lowest price, in accordance with national and international law, and in a competitive and transparent process

3 Quality Assurance Policy  3 rd Board meeting, October 2002 : First Quality Assurance Policy Multisource products Single and limited source products : criteria A, B and C  10th Board meeting, April 2005: Revision of the QA policy Multisource products Single and limited source products : criteria A, B and redefinition of the C criteria, defining two new criteria, Ci and Cii  16th Board meeting, November 2007: request for the review of the QA Policy taking into account alignment with partner’s QA policies concerns about the safety, stability and efficacy of products market dynamics (and lessons learned from the implementation of the current policy). The proposed new policy to be presented at the 18 th Board Meeting in November 2008

4 The Global Fund QA Policy Multi-Source Pharmaceutical Products Products generally off-patent and product standards are available in the public domain (e.g.: monogrph for Finished product published in Int.P, BP and USP before October 2002) Products tend to be available from a wide-range of manufacturers Single and Limited-Source Pharmaceutical Products Products for which there are no publicly available QA standards, analytical methods, and reference substances for the finished dosage form (No monograph in Int.P, BP or USP ) Products tend to be available from one or limited number of manufacturers Definition

5 The Current Global Fund QA Policy: Multi-Source Pharmaceutical Products Single and Limited-Source Pharmaceutical Products Must comply with quality standards and requirements of Drug Regulatory Authority in the recipient country. Must procure single or limited source pharmaceutical products that meets the criteria approved by the Global Fund Board Must comply with quality standards and requirements of Drug Regulatory Authority in the recipient country. and

6 QA Policy for single and limited source products since April 2005 Current QA Policy for single- and limited-source products Option A: Products pre-qualified by WHO ( UN procurement quality and sourcing project) Option B: Products registered by a stringent regulatory authority Option Ci: The manufacturer has submitted an application for pre- qualification to the WHO or approval from a stringent regulatory authority and the manufacturing site is GMP compliant as certified by WHO or a stringent regulatory authority. Option Cii: The product is manufactured at a GMP compliant manufacturing site as certified by WHO or a stringent regulatory authority

7 QA Policy for single and limited source products since April 2005  Order of priority for procurement of limited and single source products is:  if there are 2 or more A or B products available then only A or B products should be procured  if only one A/B or no A/B product available:then option Ci and Cii product can be selected in order of priority Ci over Cii  Procurement under Option Ci/Cii  time-limited  approved by GF Secretariat:  review of the notification sent by PR  quality control of the lots before shipment to the country

8 Quality Control  Sampling at manufacturing sites  Testing of products in qualified laboratories  Test methods:  Use Pharmacopoeia ( International, British or US) methods when available  Use of manufacturer’s validated methods and specifications  Items to be tested and reported:  Appearance  Identification, assay, and impurity control  Dissolution or disintegration for tablets and capsules  Content uniformity or weight variation for Tablets and capsules  pH and microbial limits for the solutions ( if in the spec.)  Sterility and Bacterial endotoxin test (for injectables) à

9 Communication of the results Interpretation and conclusion:  A lot is found acceptable if the results of the testing are within the pharmacopoeia or manufacturer’s specifications  The GF to review SGS reports /recommendations  The GF to prepare final conclusion: batch Pass, to be supplied batch Fail, should not be supplied,  The GF to send CoA and conclusion to PR and to Supplier

10 More than 76 % of the of POs for ARVs concerned products classified as AB, A or B products, products assessed for quality, safety and efficacy by WHO prequalification program or SDRA ( SDRA: Stringent Drug Regulatory Authority) Analysis of ARVS past procurement

11 Classification of Single and limited source of ARVs purchased since May 2005

12 Quality Assurance: Testing Activities As of July 2008  Quality Control of 30 ARVs ( INN, strength, dosage form) from Aspen, Aurobindo, Cipla, Hetero, Matrix, Ranbaxy, Strides  QC 68 lots completed  QC of 14 lots in QC process  100 % of lot tested passed the QC criteria All Ci or Cii products have proven to be of acceptable quality according to Standards

13 Procurement and Supply Management

14 THANK YOU