Ensuring quality of medicines procured with Global Fund resources

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Ensuring quality of medicines procured with
Global Fund resources

HIV AIDS conference Satellite on Essential
Medicines for HIV AIDS

Mexico 6 August 2008
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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

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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 partners 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
  18th Board Meeting in November 2008

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The Global Fund QA Policy
Definition

• 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

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The Current Global Fund QA Policy

• Multi-Source Pharmaceutical Products

• Single and Limited-Source Pharmaceutical
  Products

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
and
Must comply with quality standards and
requirements of Drug Regulatory Authority in
the recipient country.
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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
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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 availablethen
  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

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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 manufacturers 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
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Communication of the results

• Interpretation and conclusion
• A lot is found acceptable if the results of the
  testing are within the pharmacopoeia or
  manufacturers 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

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Analysis of ARVS past procurement
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)
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Classification of Single and limited source of
ARVs purchased since May 2005

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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

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Procurement and Supply Management
http//www.theglobalfund.org/en/about/procurement/

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• THANK YOU