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The Global Fund Quality Assurance Policy for Pharmaceutical Products. Dr Joelle Daviaud Senior Pharmaceutical Quality Assurance Officer Pharmaceutical Management Unit Global Fund.

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slide1

The Global Fund Quality Assurance

Policy for Pharmaceutical Products

Dr Joelle Daviaud

Senior Pharmaceutical Quality Assurance Officer

Pharmaceutical Management Unit Global Fund

Interregional Seminar for Quality Control Laboratories involved in WHO Prequalification Programme and/or participating in respective sampling and testing projects, Nairobi, Kenya, 23-25 September 2009

outline
Outline
  • Global Fund introduction
  • The Global Fund Quality Assurance for Pharmaceuticals products
  • The Global Fund Quality Control requirements
  • Conclusion
what is the global fund
What is the Global Fund?

As a partnership between governments, civil society, the private sector and affected communities, the Global Fund represents an innovative approach to international health financing.

As a financing mechanism, The Global Fund's purpose is to attract, manage and disburse resources to fight AIDS, TB and malaria. We do not implement programs directly, relying instead on the knowledge of local experts.

The Global Fund is a financial institution, about 35 % of grant funds are for medicines and health products procurement.

The GF does not conduct any procurement activities for pharmaceutical products, PR are responsible for ensuring adherence to Global Fund QA/QC requirements

status of global fund grants

Financing more than 600 grants in 142 countries (Sept 2009)

Status of Global Fund Grants

Objective of the Global Fund

“making a “sustainable and significant” contribution

to the achievement of the Millennium Development Goals”

distribution of funding
Distribution of funding

Pharmaceuticals

9% Others

6% TB

65%

ARV’s

20% ACT’s

what it can include
What it can include

Products

Pharmaceuticals

Health products

Health equipment

Equipment

Services

Registration

Selection

Forecasting

Procurement

Transport

Quality control

Storage

Distribution

Monitoring

Pharmacovigilance

Activities

  • Procurement costs
  • Distribution costs
  • Training
  • Technical Assistance
  • Capacity Building
t he global fund s approach to p rocurement and s upply m anagement
The Global Fund’s approach to Procurement and Supply Management
  • Build upon National/International existing systems with no prescriptive procedures but principles and minimum standards
  • Expanded definition of Procurement:
    • Getting sufficient health product of assured quality
    • Assessing products at reception in country
    • Checking the distribution chain until the end user
  • PR procurement systems must adhere to Interagency Guidelines on Good Pharmaceutical Procurement (WHO 1999)
  • Principal Recipient (PR) is responsible for all PSM activities (whether directly implemented or sub-contracted).
    • Procure quality assured products at the lowest possible price
    • Adhere to National and International Laws
    • Conduct procurement in a transparent and competitive manner
slide8

The long and winding road of Procurement…

Country Proposal is

approved for TGF Grant

PR prepares PSM Plan

specifying health products

and quantities to order

Plan is submitted

to TGF/LFA for

assessment

and approval

PR reconciles needs

and funds available

PR launches procurement process

TGF disburses

funds to Principal Recipient (PR)

Suppliers submit bids

PR evaluates bids

and awards supply

contract

PR places order for

drugs and monitors

order status

PR receives

and checks drugs,including Quality Monitoring

PR

distributes drugs

PR

makes payment

PR

collects

consumption

information

Patient

receives

drugs

PR

reports

results to TGF

global fund quality assurance policy for pharmaceuticals
Global Fund Quality Assurance policy for Pharmaceuticals
  • The Board approved the Quality Assurance Policy for Pharmaceutical Products (“QA Policy”) at its 18th Board, November 2008
  • The QA Policy came into effect on 1 July 2009 and is replacing the Global Fund’s previous policy for the quality assurance of pharmaceutical products
  • Revision of the GF Policy:
      • concerns about the safety, stability and efficacy of products,
      • alignment with partner’s QA policies
      • market dynamics and,
      • lessons learned from the implementation of the existing Policy
key elements of the revised qa policy
Key Elements of the revised QA policy
  • Clinical criteria
  • Quality criteria
  • Selection process of FPPs
  • New definition of SRAs
  • Independent expert review panel
  • Monitoring product quality
clinical criteria
Clinical criteria
  • Medicines listed in WHO or national or institutional Standard Treatment Guidelines (STGs)
  • Require grant applicants or PRs to provide technical justification for selection of unlisted products in one of the STGs
quality criteria
Quality Criteria
  • Same Quality criteria for ARVs, anti-TB and antimalarials:

Authorized for use by Drug Regulatory Authority (DRA) in recipient country

  • Selection of ARVs, anti-TB and antimalarials FPPs, either
    • WHO prequalified (A) or
    • SRA authorized (B) or
    • Recommended for use by an Expert Review Panel (ERP) for FPPs not yet WHO prequalified nor SRA authorized
slide13

Selection of products-flow chart

2 or more A or B products Available?

No

ERP recommended Product available?

Yes

No

Yes

GF request an ad Hoc ERP committee to review eligible product

  • Notify TGF
  • Receive No Objection
  • QC Testing by TGF
  • Final letter with QC result

Procure

A or B Product

ERP Product shipment

Product unavailability definition:

Inability to supply sufficient quantity of product within 90 days from date of order

the expert review panel
The Expert Review Panel
  • An independent technical body
  • Hosted by WHO Department of Essential Medicines and Pharmaceutical Policies
  • Composed of external technical experts.
  • Purposes:
    • To review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA-authorized.
    • To make recommendations to the Global Fund
expert review panel erp mechanism 1
Expert Review Panel (ERP) mechanism (1)
  • Review
    • at the request of the Global Fund, or
    • based on manufacturer’ submissions in response to GF invitation for EoI to submit dossiers.
  • A product is eligible for review by the ERP if:
    • Application to WHO Prequalification or application for marketing authorization to an SRA is accepted, and
      • Manufacturing site GMP compliant
expert review panel erp mechanism 2
Expert Review Panel (ERP) mechanism (2)
  • ERP reviews each submission to determine whether the benefits of funding the product with Global Fund resources outweigh the potential quality risks.
    • Manufacturers is notified of the outcome of the ERP’s review.
  • ERP recommendations
    • Time limited recommendations (maximum 12 months)
    • Possibility of extending the recommendation period, under certain circumstances
technical areas of erp review
Technical Areas of ERP review

Standard Product questionnaire dossier( based on Inter Agency Questionnaire):

  • product registration information;
  • regulatory (licensing) status of the FPP and manufacturing facility (GMP);
  • finished product specifications and information regarding compliance with international pharmacopoeia standards, if available;
  • stability testing data (both accelerated and real time studies) as per ICH and/or WHO Guidelines;
  • product labelling information;
  • active pharmaceutical ingredient (API) characteristics and certification; and
  • safety and efficacy data for innovator products , human bioequivalence data for generic products.
procurement of all other fpps non atm drugs
Procurement of All Other FPPs ( non ATM drugs)
  • All FPPs, other than antiretrovirals, anti-tuberculosis and anti-malarial FPPs, need only to comply with the relevant quality standards that are established by the National Drug Regulatory Authority (NDRA) in the country of use
  • PRs must ensure that all FPPs are procured in accordance with principles set forth in the Interagency Guidelines: “A Model Quality Assurance System for Procurement Agencies “ (WHO, 2007)
implementation of the revised qa policy progress update
Implementation of the revised QA Policy Progress update
  • List of 28 ERP recommended published in June 2009
  • No notification received for procurement of ERP

recommended products since 1 July 2009

  • Second ERP review planned first week of October 2009
monitoring of product quality
Monitoring of product quality

All pharmaceutical products funded by GF are subject to the monitoring of product quality

  • Monitoring quality of products all along the supply chain
  • Systematic random quality control testing
  • PR to report testing results to Global Fund
quality control laboratory qualification
Quality Control: Laboratory qualification
  • The PR responsible for the grant must select the Quality Control laboratory:
    • the NDRA laboratory
    • a QC laboratory recognized by the NDRA of the recipient country.
  • The selected Quality Control laboratory should be:
    • WHO prequalified and listed in WHO website.
    • Quality Control laboratory complying with standards at least equivalent to WHO standards recommended for pharmaceutical quality control laboratories.
    • ISO/IEC 17025 certified for the required scope of drug testing
  • It is highly recommended that the selected laboratory regularly participates in national and or international proficiency testing schemes
quality control sampling
Quality Control: Sampling
  • PR to define with the QC laboratory
    • Plan of testing
    • Documentation to be collected
    • Sampling procedure
    • Tests to be done and timeline
    • Reporting process
  • Sampling to be done
    • by trained staff
    • according to appropriate standard operating procedure
    • with careful attention to storage condition
    • at different distribution sites
quality control parameters tested
Quality Control: Parameters tested
  • Appearance, Identification
  • Related substances
  • Assay
  • Disintegration and or dissolution tests
  • Uniformity of weight
  • pH and microbial limits for solutions
  • Sterility and bacterial endo-toxins test for injectables.
quality control recommended methods
Quality Control: recommended methods

The laboratory should have the technical capabilities :

  • to undertake tests as specified in the monograph of B.P, U.S.P, and Int. Pharmacopoeia.
  • to adopt the specifications for testing as provided by the manufacturer for products that do not have monograph in B.P, U.S.P, Int. Ph.
    • to perform method transfer process to evaluate the correctness of the method of the manufacturer.
quality control applicable erp recommended fpps gf secretariat responsibilities 1
Quality Control applicable ERP recommended FPPs: GF Secretariat responsibilities (1)

Tested after notification submitted by Principal Recipient and approved by the Global Fund Secretariat

  • Sampling at manufacturing sites by GF contracted Laboratory
  • Testing of products in qualified laboratories: SGS Laboratory in Belgium, selected through competitive process
  • Test methods:
    • Use Pharmacopoeia ( International, British or US) methods when available
    • Use of manufacturer’s validated methods and specifications when no monograph available in Pharmacopoeia (International, British or US). Need of method transfer

à

quality control applicable erp recommended fpps gf secretariat responsibilities 2
Quality Control applicable ERP recommended FPPs: GF Secretariat responsibilities (2)

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)
slide28
Quality Control applicable to ERP recommended FPPs (Ci and Cii products): GF Secretariat responsibilities
  • Interpretation :
    • a lot is acceptable if the results of the testing are within the pharmacopoeia or manufacturer’s specifications
    • batch Pass, to be supplied, CoA issued by SGS sent to manufacturer and to PR
    • batch Fail, should not be supplied, manufacturer and PR informed, investigation by manufacturer and information sent to WHO
  • As of September 2009, Quality Control of 240 batches
    • QC 240 lots (ARV-114 batches; ACT-126 batches) completed: green light for the shipment of these products have been sent accordingly to manufacturer

100 % of lot tested passed the QC criteria

    • Results and CoAs will be soon published on GF website : avoid duplication of testing , assure full transparency
qa compliance
QA Compliance
  • If PRs select ERP recommended products, PRs must notify the Secretariat before procuring them.
  • It is mandatory that procurement of ARVs, anti-TB, antimalarial products, bed nets, condoms, rapid diagnostic tests are reported in the Price Quality Reporting system (PQR)
  • The QADM Team monitor compliance with QA Policy based on PQR data and produces:
    • Monthly report to Country Programs for action: notify FPMs of potential non compliance
    • Compliance analysis for Phase 2 Review.

In case of non compliance, corrective measures applies

how it works
How it works?

The Global Fund

Monitor

Price

Delivery Conditions

Quality

Market Information

Price Comparison

Quality Monitoring

Principal Recipients

P

Q

R

General Public

Principal Recipient

Reports

Partners

Verify Data

Local Fund Agent

conclusion 1 uniform stringent standards
Conclusion (1)Uniform stringent standards
  • All antiretrovirals, first-line anti-TB medicines and antimalarials must comply with stringent quality requirements
  • “Other” medicines (single- and multi-source) need only be authorized in the country of use for the time being
  • Quality monitoring at country for all FPPs funded with Global Fund ressorces to be reinforced and be strengthened
    • protocols and guidelines to help PR in this activity are under development in close collaboration with the WHO PQ programme
conclusions 2 ncls role in the quality monitoring at country level
Conclusions (2)NCLs’role in the Quality Monitoring at country level
  • The Global Funds recommends to use existing system in place at country level, if system is functional and complies with GF requirements
  • NCLs have a clear role in the quality monitoring activity of FPPS funded by the Global Fund
conclusions 3 ncls role in the quality monitoring at country level
Conclusions (3)NCLs’role in the Quality Monitoring at country level
  • Recommendations to NCLS:
    • To get WHO prequalification status as soon as possible to be part of laboratory selected by the PR
    • To work closely with the NDRA and MOH for the development of Global Fund proposal
      • To discuss budget implication of QC tests for FPPs funded by the Global Fund
      • To request Technical Assistance/ Funding for improving their quality control capacities
    • To work closely with the PR to be an active body in the Quality Assurance process set up by the PR for the quality monitoring of FPPs funded by the Global Fund
quality control of pharmaceutical products website links
Quality Control of Pharmaceutical Products: website links

For information

  • Frequently-Asked Questions (FAQs) about Quality-Control Testing of Pharmaceutical Products http://www.theglobalfund.org/pdf/guidelines/QCTestingPharmaceuticalProducts.pdf
  • WHO Prequalified Laboratories:

http://healthtech.who.int/pq/lists/PQ_QCLabsList.pdf

Contact for Enquiries: email: prequallaboratories@who.int

  • Model Quality Assurance System for procurement agencies , World Health Organization, WHO Technical Report Series, No. 937, 2006 Annex 6, http://healthtech.who.int/pq/info_general/documents/TRS937/WHO_TRS_937__annex6_eng.pdf