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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
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
Global Fund introduction
The Global Fund Quality Assurance for Pharmaceuticals products
The Global Fund Quality Control requirements

Conclusion
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Sampling and testing for Quality Control Laboratories, Nairobi, September 2009
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
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Status of Global Fund Grants

Financing more than 600 grants in 142 countries (Sept 2009)
Financial Status Proposals Approved (R1-8) Global Fund financing (US$), September 2009 Grants signed US$ Money disbursed
US$
16.2 billion
12.2 billion
8.3 billion
51%
Objective of the Global Fund making a sustainable and significant contribution to the achievement of the Millennium Development Goals
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Distribution of funding
Pharmaceuticals
9% Others
6% TB
65% ARVs 20% ACTs
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What it can include

Products
Pharmaceuticals Health products Health equipment
Services
Registration
Selection
Forecasting
Activities
Procurement costs Distribution costs Training Technical Assistance Capacity Building
Procurement Transport Quality control Storage Distribution Monitoring
Equipment
Pharmacovigilance
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The Global Funds 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
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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
TGF disburses funds to Principal Recipient (PR)
PR reconciles needs and funds available
PR launches procurement process
Suppliers submit bids

PR receives and checks drugs,including Quality Monitoring
PR evaluates bids and awards supply contract
PR places order for drugs and monitors order status
PR makes payment PR collects consumption information
PR distributes drugs
Patient receives drugs
PR reports results to TGF
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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 Funds 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 partners QA policies market dynamics and, lessons learned from the implementation of the existing Policy
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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
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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
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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
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Selection of products-flow chart

2 or more A or B products Available?
No
ERP recommended Product available?
Yes

Yes
Notify TGF Receive No Objection QC Testing by TGF Final letter with QC result
ERP Product shipment
No
GF request an ad Hoc ERP committee to review eligible product
Procure A or B Product
Product unavailability definition: Inability to supply sufficient quantity of product within 90 days from date of order
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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 SRAauthorized. To make recommendations to the Global Fund
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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
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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 ERPs review.
ERP recommendations Time limited recommendations (maximum 12 months) Possibility of extending the recommendation period, under certain circumstances
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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.
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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)
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Implementation of the revised QA Policy Progress update

List of 28 ERP recommended published in June 2009
Outcome of First ERP review Malaria
Products dossier reviewed ERP recommended (time limited)
18
Tuberculosis
HIV
12
30
10
15
No notification received for procurement of ERP recommended products since 1 July 2009 Second ERP review planned first week of October 2009
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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
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Quality Control of Pharmaceutical Products
Quality Control of FPP

Responsibility
All FPPs
ERP recommended FPPs

GF Secretariat , paid by GF secretariat Notification submission by PR to GF No Objection by GF Before any shipment of drugs to the country Mandatory for all Purchase order (PO)
PR or sub recipient, cost may be included in the GF grant budget In accordance with the Good Procurement Practice After receipt of drugs at country Level, along the supply chain At random
Condition
When Frequency
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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
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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

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by trained staff according to appropriate standard operating procedure with careful attention to storage condition at different distribution sites
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.
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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.
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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 manufacturers validated methods and specifications when no monograph available in Pharmacopoeia (International, British or US). Need of method transfer
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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)
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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 manufacturers 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
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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
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How it works?
The Global Fund
Monitor
Principal Recipient
Price
Quality
Delivery Conditions
Reports
Q
R
Verify Data
Price Comparison Quality Monitoring

Market Information
Principal Recipients
General Public Partners
Local Fund Agent

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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
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Conclusions (2) NCLsrole 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
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Conclusions (3) NCLsrole 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
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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__annex 6_eng.pdf
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Hochgeladen von

Copyright:

Verfügbare Formate

The Global Fund Quality Assurance

Policy for Pharmaceutical Products

The Global Fund Quality Control requirements

What is the Global Fund?

Status of Global Fund Grants

What it can include

Procurement Transport Quality control Storage Distribution Monitoring

The Global Funds approach to Procurement and Supply Management

The long and winding road of Procurement

TGF disburses funds to Principal Recipient (PR)

PR reconciles needs and funds available

PR launches procurement process

Suppliers submit bids

PR evaluates bids and awards supply contract

PR places order for drugs and monitors order status

PR makes payment PR collects consumption information

Patient receives drugs

PR reports results to TGF

Global Fund Quality Assurance policy for Pharmaceuticals

Key Elements of the revised QA policy

Medicines listed in WHO or national or institutional Standard Treatment Guidelines (STGs)

Selection of products-flow chart

The Expert Review Panel

Expert Review Panel (ERP) mechanism (1)

Expert Review Panel (ERP) mechanism (2)

Technical Areas of ERP review

Procurement of All Other FPPs ( non ATM drugs)

Implementation of the revised QA Policy Progress update

Monitoring of product quality

Systematic random quality control testing

Quality Control of Pharmaceutical Products

Quality Control of FPP

ERP recommended FPPs

Quality Control: Laboratory qualification

Quality Control: Sampling

Quality Control: Parameters tested

Quality Control: recommended methods

Quality Control applicable ERP recommended FPPs: GF Secretariat responsibilities (1)

Quality Control applicable ERP recommended FPPs: GF Secretariat responsibilities (2)

In case of non compliance, corrective measures applies

Price Comparison Quality Monitoring

Local Fund Agent

Conclusions (2) NCLsrole in the Quality Monitoring at country level

Conclusions (3) NCLsrole in the Quality Monitoring at country level

Quality Control of Pharmaceutical Products: website links

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

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