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Transcript of Procurement policies and requirements - WHO/OMS: … · Procurement policies and requirements...
Procurement policies and requirements
Monika Zweygarth
Consultant
JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
2 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Organizations that contributed to this presentation
• WHO Prequalification of Medicines Programme (PQP) • WHO Global Procurement and Logistics unit (GPL) • UNICEF Supply Division Copenhagen, Denmark • MSF - Médecins Sans Frontières • Global Fund to Fight AIDS, Tuberculosis and Malaria • ICRC - International Committee of the Red Cross • The Union (International Union against TB and Lung Disease) • UNFPA • GDF – Global Drug Facility
3 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Key health products funded
Medicines: ARVs, Antimalarials, Anti-TB, Reproductive health products, Other essential meds
Non-pharma: Bednets, Condoms, Diagnostic products, Reagents and Laboratory supplies, Nutritional supplements …
4 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Outline of presentation
1. QA policies for medicines, diagnostics, other products
2. Procurement and pre-shipment testing
3. Monitoring product quality in countries
5 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
1. QA policies
6 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
Harmonized QA policies • UNICEF: www.unicef.org/supply/index_41948.html
Contact: [email protected], [email protected] • UNFPA: www.unfpa.org/public/home/procurement/pid/10863 • MSF: www.msf.org/3/www.msf.org/msf/articles/2011/03/msf-drugs-
procurement---general-principles.cfm.htm Contact: [email protected]
• Global Fund www.theglobalfund.org/en/procurement/quality/pharmaceutical www.theglobalfund.org/en/procurement/quality/diagnostics Contact: [email protected]
• ICRC www.icrc.org ; Contact: [email protected] • The Union: www.theunion.org ; Contact: [email protected] • GDF: www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp
7 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
Stringent standards for key pharmaceuticals Vaccines ARVs, anti-TB, anti-malarials
Reproductive health Other essential medicines
WHO- pre-
qualified
WHO-prequalified, or
Approved by a Stringent Regulatory Authority (SRA)
--------------------------------
OR
Rapid risk review by ERP or
Agencies‘ own qualification
Authorized for use in destination country;
Agencies’ own qualification
Recognition of WHO-prequalification
SRA-approval
Vaccines ARVs, anti-TB, anti-malarials Reproductive health
Other essential medicines
WHO- pre-
qualified 1
WHO-prequalified 2, or
Approved by a Stringent Regulatory Authority (SRA) = ICH members,
observers and associates 3 --------------------------------
If products meeting these criteria are not available on the market:
Rapid risk review by ERP or
Agencies‘ own qualification
Authorized for use in destination country;
Agencies’ own qualification
based on GMP audit & product dossier
assessment (UNICEF, MSF, ICRC, Union)
Recognition of WHO-prequalification 2 (selected
medicines) SRA-approval
1. www.who.int/immunization_standards/vaccine_quality/pq_system/en/index.html 2. WHO Prequalification of Medicines Programme (PQP): www.who.int/prequal 3. SRAs: Listed in each organization’s QA policy
8 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
Rapid risk review by Expert Review Panel (ERP)1
Dossier assessment Must be under stringent review
ERP reviews abridged dossier
Inspection Site must have stringent GMP
ERP verifies GMP status
Positive ERP opinion is valid for one year Outcomes on Global Fund website, used by many agencies
Dossier assessment Product dossier must have been accepted for review by WHO-PQP or an SRA (if the medicine/strength is invited for WHO prequalification)
ERP reviews abridged dossier
Positive ERP opinion is valid for one year Outcomes2 are used by:
Global Fund; GDF; UNITAID, UNFPA; MSF; The Union; ICRC; UNICEF (for ACTs) …
1. Expert Review Panel, hosted by WHO. More information on ERP: http://apps.who.int/prequal/info_press/pq_news_27April2012_ERP.htm
2. ERP-approved products are listed online at www.theglobalfund.org/en/procurement/quality/pharmaceutical/#Lists
Inspection Manufacturing site (production line) must be GMP-certified by WHO-PQP or by an ICH or PIC/s member
ERP verifies GMP status
9 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
Agencies’ own supplier qualification
Dossier assessment*
– Product questionnaire
– Periodic requalification
Audit
– Stringent GMP standards
– Recognition of other stringent audits
– Periodic re-audit
Harmonized principles, stringent standards Inter-agency discussion, sharing of audit outcomes
Audit (production-line specific):
Stringent standards: WHO-PQP, SRA, PIC/s (UNICEF=PIC/S Partner 2)
Recognition of other stringent audits (as per agencies’ policies)
Periodic re-audit (risk-based, every 1-5 years)
1. Questionnaire based on Annex to WHO Model QA system for procurement agencies http://www.unicef.org/supply/index_52844.html
2. PIC-S Quality System requirements for GMP inspectorates: www.picscheme.org/.../PI002-3RecommendationonQualitySystem.pdf
Dossier assessment*
Common product questionnaire, based on WHO guidance1
Periodic requalification, risk-based every 3 to 5 years UNICEF approval is linked to bidding MSF: monitoring of dossiers; variation assessment
10 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
Manufactured in compliance with ISO 13485 where applicable, else ISO 9000 + for HIV immunoassays:
• GHTF founder member approval or
• WHO technical assessment + for Malaria RDTs: • WHO technical assessment,
or • Positive WHO advice on GHTF approval
Other RDTs • WHO technical review Joint annual tender conducted with UNICEF
In vitro diagnostic products must be manufactured at a site compliant with ISO 13485 where applicable, else ISO 9000 series + HIV RDTs, ELISA and W/Blot must pass
• GHTF founder member approval (regulatory authorities of USA, Japan, EU, Canada, Australia) or
• WHO technical assessment + Malaria RDTs must pass
• WHO technical assessment, or
• Have a positive WHO advice on assessment to requirements of a GHTF founder member
Other RDTs-hepatitis, dengue, leishmania, measles, rubella, syphilis, cholera
• WHO technical review Joint annual tender conducted with UNICEF
Global Fund policy: www.theglobalfund.org/en/procurement/quality/diagnostics WHO PQ of diagnostics: http://www.who.int/diagnostics_laboratory/evaluations/en/
Diagnostic products
Global Fund
WHO/UNICEF
11 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
Quality standards: Other non-pharma products
Laboratory supplies
Condoms, IUDs
Bednets Other
Reagents, laboratory items for general use: WHO GLI 1 WHO EHT 2
UNFPA3 Specification, Prequalification and Guidelines for Procurement
WHOPES4
WHO Pesticide Evaluation Scheme
“..Products must be selected from lists of prequalified products, if any, and comply with quality standards applicable in country of use, if any.” (Global Fund)
1. www.stoptb.org/wg/gli/default.asp - Global Laboratory Initiative 2. www.who.int/medical_devices/en/index.html WHO Essential Health technologies 3. www.unfpa.org/public/home/procurement/pid/10863 UNFPA quality assurance 4. www.who.int/whopes/resources/en/
12 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Procurement
2. Procurement
13 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Procurement
Procurement principles
• Adherence to principles of WHO guidance: “A Model Quality Assurance System for Procurement Agencies” (MQAS)* Including WHO Good Practices: GMP, GDP, GSP…
• Transparent and competitive procurement processes
• Quality-assured products procured at best value for money • Adherence to National and International Laws
WHO guidance: www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html - see under Current projects (MQAS is under revision)
UNFPA’s Procurement Procedures
UNFPA’s Procurement Procedures supports the four Procurement Principles which are based on ethical considerations. Individuals must adhere to these principles in all procurement situations:
• Best value for money • Fairness, integrity and transparency • Open and effective competition • The interest of UNFPA
15 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
QA Policies
• Compliance with UNICEF Financial Rules and Regulations
• Compliance with Public Procurement Principles • Integrity • Transparency • Fair competition • Equal Treatment • Best value for money • Organizational Objectives
• Apply procurement strategy that supports a
healthy development of the market
UNICEF PROCUREMENT: GUIDING PRINCIPLES
16 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Procurement
Good distribution practices (GDP)
Some examples from agencies’ policy and practice:
• Technical audits/visits to procurement agencies before awarding contracts
• Pre-shipment inspection: visual inspection at warehouse and review of CoA – shelf life, manufacturing site
• (Planned:) Require documentation of controlled shipment conditions, including temperature control (UNICEF, MSF, ICRC)
17 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Procurement
Frequency Random, pre-defined risk-based plan depending on • Past QC record of product
• Type of approval
• Complexity of product
Laboratory WHO prequalified or ISO 17025-certified Methods Compendial (public) where possible
Global Fund publishes all pre-shipment QC testing results online
Frequency Random, according to pre-defined testing plan Risk-based frequency • E.g. all of first 5-10 batches, then 10-20% as long as no
quality problems • Less or no testing of WHO-PQ’d and SRA-approved
products, except for AMFm (antimalarials) • Mandatory for all orders of ERP-approved products
Laboratory WHO prequalified or ISO 17025-certified laboratory Methods WHO International Pharmacopoeia (Ph. Int.), US
Pharmacopeia (USP) or British Pharmacopoeia (BP) when possible
Global Fund publishes all pre-shipment QC testing results online www.theglobalfund.org/documents/psm/CoAs/PSM_CoAs_List_en/
Pre-shipment Quality Control: Medicines As per Global Fund QA requirements – applied similarly by most other agencies
18 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Procurement
Pre-shipment Quality Control: Non-pharma
Diagnostics (lot testing) Condoms Bednets
HIV and Malaria RDTs, subject to lab capacity
All batches tested
Review manufacturer’s CoA
+ random testing
WHO-recommended
Laboratory
Independent sampling and
testing (ISO)
Independent sampling & testing (ISO)
WHO Collaborating Centre
Methods as per WHO guidance
ISO 4074: 2002 standards
WHO Methods and Specifications (WHOPES)
As per Global Fund requirements – applied similarly by other agencies
Diagnostics (lot testing) Condoms1 Bednets2
Random testing for HIV and Malaria RDTs, subject to testing capacity of WHO-
recommended lab
All batches tested Systematic review of Manufacturer’s CoA and
random testing
Testing laboratory as per WHO guidance
Discussions among partners to better share resources
Independent sampling agent
(ISO 2859-1) Independent ISO
17025-certified lab
Independent sampling agent Independent ISO-17025
certified lab WHO Collaborating Centre for
QC of Pesticides Methods subject to WHO guidance for product type
ISO 4074: 2002 standards
WHO Methods and Specifications (WHOPES)
1 www.unfpa.org/public/home/procurement/pid/10866 2 www.who.int/whopes/quality/en/
19 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Quality monitoring
3. Quality monitoring
20 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Quality monitoring
Quality monitoring during and after purchase
• Supplier commits to product identity at each delivery: – In tender documents – On delivery, e.g. Signed Product Specification Sheet (MSF)
• Review of manufacturer’s CoA: Mfg. site, shelf life, trends..
• Agencies check during audits at manufacturing sites (e.g. UNICEF, MSF, ICRC)
• Global Fund Price and Quality Reporting system (PQR) +corrective measures
• Monitoring of complaints, quality problems, batch recalls…
21 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Quality monitoring
3. Post-shipment quality control testing
Aim: To detect additional failures due to storage, transport.. Examples of QC testing programmes for medicines:
• WHO-PQP performs QC testing surveys in countries
http://apps.who.int/prequal/info_applicants/qclabs/quality_monitoring.htm
• Global Fund: Risk-based QC testing all along the supply chain by a WHO-prequalified or ISO 17085-certified laboratory
• The Union organizes anti-TB medicine surveys in collaboration with NRA and partners
Condoms: Tested pre-shipment
22 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Quality monitoring
Ensuring good use of diagnostic products (As required in Global Fund QA policy for diagnostics) Recipients must :
• Use quality systems to ensure good testing: Qualified staff, adequate products for setting, calibration, maintenance, record-keeping, SOPs, supervision, External Quality Assessment (EQA) …
• Follow WHO guidance for good practice in inventory management, storage and distribution
• Arrange for systematic reporting of defects
23 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
Global QA can not be done in isolation. Agencies cooperate and share information
to maximize access to quality-assured products for their beneficiaries
Conclusion
• Reliance on WHO-prequalification and stringent regulatory bodies (second choice: ERP)
• Use of best practices for all procurement, as defined in WHO Model QA System
• Agencies’ own internal qualification for medicines not invited for WHO review
Implementation may differ slightly according to “in-house” technical resources.
Agencies are aligned on the same QA principles
25 JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen 23-25 Sep 2013
UNFPA Procurement Services Branch (PSB) Main Procurement elements
a) “Regular” transactional procurement (Statistics)
b) AccessRH: Procurement Services for “external” Clients
c) Emergency procurement and management of inventory
d) Strategic Procurement Cluster establishing LTAs
e) Quality Assurance incl. pre-qualification of factories
f) Procurement capacity buildings to governments, external and internal trainings, advise and guidance
g) Supply chain coordination for better procurement & programme integration
http://www.unfpa.org/public/procurement