Procurement policies and requirements - WHO/OMS: … · Procurement policies and requirements Monika Zweygarth Consultant JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen

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


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 …


Outline of presentation

1. QA policies for medicines, diagnostics, other products

2. Procurement and pre-shipment testing

3. Monitoring product quality in countries


QA Policies

1. QA policies


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

http://www.unicef.org/supply/index_41948.html

mailto:[email protected]


http://www.unfpa.org/public/home/procurement/pid/10863

http://www.msf.org/3/www.msf.org/msf/articles/2011/03/msf-drugs-procurement---general-principles.cfm.htm

http://www.msf.org/3/www.msf.org/msf/articles/2011/03/msf-drugs-procurement---general-principles.cfm.htm


http://www.theglobalfund.org/en/procurement/quality/pharmaceutical

http://www.theglobalfund.org/en/procurement/quality/diagnostics


http://www.icrc.org/


http://www.theunion.org/


http://www.stoptb.org/gdf/drugsupply/quality_sourcing_process.asp


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

http://www.who.int/immunization_standards/vaccine_quality/pq_system/en/index.html

http://www.who.int/prequal


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

http://apps.who.int/prequal/info_press/pq_news_27April2012_ERP.htm

http://www.theglobalfund.org/en/procurement/quality/pharmaceutical/


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

http://www.unicef.org/supply/index_52844.html

http://www.picscheme.org/.../PI002-3RecommendationonQualitySystem.pdf


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

http://www.theglobalfund.org/en/procurement/quality/diagnostics

http://www.who.int/diagnostics_laboratory/evaluations/en/


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/

http://www.stoptb.org/wg/gli/default.asp

http://www.who.int/medical_devices/en/index.html


http://www.who.int/whopes/resources/en/


Procurement

2. Procurement


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)

http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html

http://www.who.int/medicines/areas/quality_safety/quality_assurance/guidelines/en/index.html

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


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


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)


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

http://www.theglobalfund.org/documents/psm/CoAs/PSM_CoAs_List_en/


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/


http://www.who.int/whopes/quality/en/


Quality monitoring

3. Quality monitoring


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…


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

http://apps.who.int/prequal/info_applicants/qclabs/quality_monitoring.htm


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


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


Thank you


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

http://www.unfpa.org/public/procurement

Documents

Procurement policies and requirements - WHO/OMS: … · Procurement policies and requirements Monika Zweygarth Consultant JOINT UNICEF, UNFPA & WHO meeting with manufacturers, Copenhagen