CAMBODIAQUALITY ASSURANCEACT PACKAGING EXPERIENCE AND PROCUREMENT GUIDELINES

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CAMBODIA-QUALITY ASSURANCE-ACT PACKAGING
EXPERIENCE AND PROCUREMENT GUIDELINES

• Presented by CAMBODIA TEAM
• GF REGIONAL MEETING
• 3-5 SEPTEMBER 2007
• BALI, INDONESIA

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QUALITY ASSURANCE - PHARMACEUTICALS

• Ministry of Health is working on the assessment
  of Quality Assurance on Public and Private
  Sector. Supplement to the initiative taken by
  MoH GF requested MoH/PR to include the
  following-
• GRANT AGREEMENT ROUND 5
• GF REQUIREMENT AS PER PGA -30 AUGUST 2006
• No later than Six months after the Program
  starting date the Principal Recipient shall
  deliver to the GF a Quality Assurance plan in
  form and substance acceptable to the fund, for
  TESTING the Quality of Pharmaceuticals procured
  with Grant Funds.

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ISSUES

• No budget plan for collection of samples from
  various sites
• No budget plan for testing of samples in the
  approved proposal
• NCQL has limited equipment and qualified and
  experience personnel.
• Funds to use the reference laboratory is not
  planned in the proposal.
• Procedure for use the reference laboratory is not
  clear.
• Inadequate guidance provided by Global Fund for
  preparation of the Quality Assurance Plan.
• Guidance provided by GF was understood as mainly
  testing of pharmaceuticals.
• Pre-Tender and Post Tender process was not
  properly defined by GF during the early stages of
  preparation of the QA Plan.

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CHALENGES

• Roles and responsibilities of staff who are
  involved in the QA implementation need to have
  comprehensive training on new QA plan.
• Documents related (NDP and EML) to quality
  assurance of MoH need to be updated in order to
  meet the required QA by GF
• Role and responsibility for each related
  institution involved in the QA plan need to be
  further discussed and agreed upon with the
  approval of MoH.
• R5 second disbursement is a condition precedent
  on submission of QA policy.
• All products and batches are subject to Random
  Quality Control.
• Is Quality Assurance a new layer over and above
  the WHO Pre-Qualifications?

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FINAL QUALITY ASSURANCE POLICY DEVELOPED BY MoH
as PR AWAITING GF APPROVAL
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ARTEMISININ COMBINATION THERAPY DRUG PROCUREMENT
AND PACKAGING

• Current situation CPE Non Compliance with GF
  Quality Assurance Policy in Packaging.
• Why did GF Request to perform test on ACT
  product?
• What are the solutions for the future?

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PACKAGING OF ACTS IN CAMBODIA

• Since 2005 with the support of the WHO ACTs were
  packaged in Cambodia at CPE.
• Purchased and shipped the drugs products from the
  (original) manufacturers for packaging into
  blister pack in Cambodia.
• Packaged products were tested for quality
  assurance by SGS and found No defects.
• UNITAD FUNDS Flow only packaging plant is GMP
  Certified by WHO

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PACKAGING OF ACTS IN CAMBODIA

• WHO consultant working with CPE has provided
  report CPE plant do not have any serious issues
  on packaging.
• Issue is CPE do not have the WHO/GMP Certificate
  for packaging.
• CAMBODIA was given only one time packaging at CPE.

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CHALLENGES FACING CAMBODIA

• Need to find a Packaging plant GMP Certified
  outside CAMBODIA. This is a very difficult issue.
• UNICEF WHO are procuring ACTS with UNITAD FUNDS
  waiting for PR to find a plant to pack the ACTs
  with WHO/GMP certification.
• CAMBODIA is facing a severe shortage of ACTs

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Procurement Supply Management Cycle

• Comprehensive procurement Guideline are in place
  approved by the GF.
• Guideline can be found from the website
  www.cambodiagfatm.org