who quality assurance policy...2018/07/16 · the firstworld health assembly in 1948 recognized the...

WHO QUALITY ASSURANCE POLICY FOR THE PROCUREMENT OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS

JUNE 2018Corporate procurement policy and coordination programme

WHO QUALITY ASSURANCE POLICY FOR THE PROCUREMENT OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS2

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3WHO QUALITY ASSURANCE POLICY FOR THE PROCUREMENT OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS

TABLE OF CONTENTS

ACRONYMS 4

1. INTRODUCTION 51.1. Procurement by WHO and responsibilities within WHO 51.2. Conflictofinterestandconfidentiality considerations in WHO procurement 61.3. The WHO Quality Assurance Group 6

2. REQUIREMENTS FOR THE PROCUREMENT OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS 6

2.1. General principles, norms and standards applicabletoWHO’sprocurementof essential medicines and other health products 62.2. Specificrequirementsfortheprocurement ofcertaintypesofessentialmedicinesand other health products 8

3. REQUIREMENTS FOR SUPPLIERS OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS TO WHO 113.1. Definitionsofsupplierandrequirements forallsuppliers 113.2. Requirementsforwholesaledistributors 123.3. Requirementsformanufacturers 133.4. Acceptingapotentialsupplierofessentialmedicines andotherhealthproductswhichisnotprequalified undertheWHOPrequalificationProgramme 153.5. RemovalofSuppliers 15

4. MONITORING THE QUALITY OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS PROCURED BY WHO, AND SUPPLIERS THEREOF 164.1. Monitoringofsuppliers’performance 164.2. Qualitytestingofessentialmedicines and other health products 164.3. Managingqualitynon-conformity 174.4. Suppliers’responsibilityforrejectedor returned products 18


ACRONYMS

CPP CertificateofapharmaceuticalproductEMA European Medicines Agency EML Essential Medicines List ERP Expert Review Panel ECSPP WHOExpertCommitteeonSpecifications forPharmaceuticalPreparationsEU European Union EUAL Emergency Use Assessment and Listing procedure (EUAL)FPP finishedpharmaceuticalproduct(s)GDP Good Distribution Practices GMP GoodManufacturingPracticesGSP Good Storage Practices GHTF Global Harmonization Task ForceICHInternationalCouncilforHarmonization ofTechnicalRequirementsforPharmaceuticals forHumanUseISO InternationalOrganizationforStandardizationIVD In vitro diagnostic medical deviceMQAS ModelQualityAssuranceSystemfor procurement agenciesNRA National Regulatory Authority PIC/SPharmaceuticalInspectionCo-operationSchemeQA Quality AssuranceQA Group WHO Quality Assurance Group QL Quality Control LaboratorySMF sitemasterfileSRA Stringent Regulatory AuthorityTGF The Global Fund to Fight Aids, Tuberculosis, and Malaria UN United NationsUNGM United Nations Global Marketplace USFDA United States Food and Drug AdministrationWHO World Health Organization WHOPQ WHOPrequalification


1. INTRODUCTION

TheprocurementofessentialmedicinesandotherhealthproductsisacriticalfunctioninsupportoftheeffectivedischargeofWHO’smandate,andWHOvaluestheimportanceofthequalityofessential medicines and health products that are supplied to countries. ThefirstWorldHealthAssembly in1948recognizedtheneedto establish a procurement service at WHO, and recommended settingupanoffice“togiveadviceontheprocurementofessentialdrugs, biological products and other medical supplies”.

ThisWHOQualityAssurancePolicyfortheProcurementofEssential Medicines and other Health Products (the Policy) sets out the principles and requirements regulating WHO procurement of essentialmedicinesandhealthproducts, includinga setof clearand transparent criteria on which potential sources and suppliers are selected and engaged. The Policy functions to update andconsolidate existing internal quality procedures into a single document. Reference should also be made to the WHO procurement rules as described on the WHO website at http://www.who.int/about/finances-accountability/procurement/en/andasmodifiedfromtimetotime.

This Policy aims for harmonization, where appropriate, with thequalityassurancepoliciesofotherUnitedNations (UN)agenciesand international organizations procuring essential medicines and other health products. WHO intends to continue to collaborate with relevant technical partners to ensure consistent application ofqualityassessmenttoolsandprocedureswithintheUNsystem.Suppliers (manufacturers andwholesaledistributors)of essentialmedicines and other health products to WHO must accept the provisionsofthisPolicyaspartoftheWHOprocurementprocessand their contractual relationship with WHO.


1.1. Procurement by WHO and responsibilities within WHO

All WHO procurement must be in line with the Organization’s rules and regulations. When WHO procures essential medicines and other health products, the procuring entity or unit collaborates with other WHO technical depart-ments as appropriate. This could include those departments responsible for creating treatmentguidelines,demandplanning,prequalificationofmedicines, vaccines an in vitro diagnostic medical devices (IVDs), as well as departments with administrative, financial and legal oversight. Externally, WHO may choose to collaborate with other UN organizations which are procuring essentialmedicinesandotherhealthproductsforsimilarprojectsand/oractivities.

Although WHO primarily acquires goods and servicestoenabletheimplementationofitsownprogramme needs, it may also conduct procure-mentforvariousgovernmenthealthprogrammesandoccasionallyforparallelactivitiesundertakenby United Nations agencies and nongovernmental organizations,subjecttotheOrganization’srulesand regulations.

1.2. Conflict of interest and confidentiality considerations in WHO procurement

WHO staff and WHO experts involved in the procurement of essential medicines and otherhealthproducts,includinganyandallqualification and/or procurement of products or suppliers,must disclose any real, potential or apparent conflicts of interest, in accordance with WHO’srules andprocedures. Information submitted toWHO related to the procurement of essentialmedicines and other health products, including any and all qualification and/or procurementof products or suppliers may be subject to confidentiality obligations and undertakings,which must be respected by WHO.

1.3. The WHO Quality Assurance Group

The WHO Quality Assurance Group (QA Group) isaninternalWHOgroupwithatechnicalfocus which aims to ensure the safety, efficacy andquality of essential medicines and health products procured by WHO. The QA Group, chaired by the Director of WHO’s Departmentof Essential Medicines (EMP), is composed of in-house technical experts and operates in accordancewithitsestablishedtermsofreference.


2. REQUIREMENTS FOR THE PROCUREMENT OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS

2.1. General principles, norms and standards applicable to WHO’s procurement of essential medicines and other health products

ThisPolicyincorporatesbyreferencethequalitystandards and guidelines established by the WHO TechnicalReportSeries,includingthefollowing:

• ThecurrentWHOModelListofEssentialMedicines (EML)1

• TheWHOGlobalAtlasofMedicalDevices;2 • TheWHOModelListofEssentialInVitro

Diagnostics(EDL);3

1-WHOModelListofEssentialMedicines,20thlist. Geneva:WorldHealthOrganization;2017 (http://www.who.int/medicines/publications/essentialmedi-cines/en/, accessed 23 January 2018)2-Globalatlasofmedicaldevices.Geneva:WorldHealthOrganization;2017. (http://www.who.int/medical_devices/publications/glob-al_atlas_meddev2017/en/, accessed 23 January 2018)3-ProposalforaWHOModelListofEssentialInVitroDiagnostics(ortheEDL).ProposedbytheDepartmentofEssential Medicines and Health Products, World Health Organization and submitted to the WHO Expert Commit-teeontheSelectionandUseofEssentialMedicinesforcommentsandrecommendations,26January2017.(http://www.who.int/selection_medicines/committees/expert/21/applications/Proposal_for_a_WHOModelListofEssential_In_Vitro_DXs_2017.pdf?ua=1, accessed 23 January 2018).

• WHO technical guidelines as approved by theWHOExpertCommitteeonSpecifica-tionsforPharmaceuticalPreparations4,5 and the Expert Committee on Biological Standardization6, and the WHO International Pharmacopoeia7;

• WHOtestingandtreatmentguidelines;8

• WHOguidanceonprocurementofIVDs and other laboratory items9;and

• WHO Medical device technical series – procurement process resource guide.10

4-Guidelines.In:EssentialMedicinesandHealthProducts[website].Geneva:WorldHealthOrganization;2018 (http://www.who.int/medicines/areas/quality_safety/quality _assurance/guidelines/en/, accessed 23 January 2018).5-ExpertCommitteeonSpecificationsforPharmaceuticalPreparations (ECSPP). In: Essential medicines and health products[website].Geneva:WorldHealthOrganization;2018(http://www.who.int/medicines/areas/quality_safety/quality _assurance/expert_committee/en/, accessed 23 January 2018).6-WHOExpertCommitteeonBiologicalStandardization(ECBS). In: Biologicals [website]. Geneva: World Health Organization;2018(http://www.who.int/biologicals/WHO_ECBS/en/, accessed 23 January 2018).7-TheInternationalPharmacopeia(17thedition). Geneva:WorldHealthOrganization;2017 (http://www.who.int/medicines/publications/pharmacopoeia/en/, accessed 23 January 2018).8-See,forexample,ConsolidatedGuidelinesonHIVTestingServices.Geneva:WorldHealthOrganization;2015(http://www.who.int/hiv/pub/guidelines/hiv-testing-services/en/, accessed 24 January 2018) and Guidelines on hepatitis B andCtesting.Geneva:WorldHealthOrganization;20179-Guidanceforprocurementofinvitrodiagnosticsandrelatedlaboratoryitemsandequipment.Geneva:WorldHealthOrganization;2017.Licence:CCBY-NC-SA3.0IGO.(http://apps.who.int/iris/bitstream/10665/255577/1/9789241512558-eng.pdf?ua=1, accessed 23 January 2018).10-Guidanceforprocurementofinvitrodiagnosticsandrelatedlaboratoryitemsandequipment.Geneva:WorldHealthOrganization;2017.Licence:CCBY-NC-SA3.0IGO.(http://apps.who.int/iris/bitstream/10665/255577/1/9789241512558-eng.pdf?ua=1, accessed 23 January 2018).


WHO mainly procures pharmaceutical products which are included in the above listed documents. When purchasing pharmaceutical products not includedintheabove-listeddocuments,theQAGroup must review and endorse the technical justificationsforsuchapurchase.

In principle, all essential medicines and other health products procured by WHO should be authorized (or exceptionally authorized) forimportation and use by the relevant National Regulatory Authority (NRA) in the country of destination. In specific contexts, for example, emergencies, WHO may choose to accept government waivers or other exceptional market authorizations to this requirement, consistentwith its rules and regulations.

2.2. Specific requirements for the procurement of certain types of essential medicines and other health products

InadditiontotherequirementssetforthinSection 2.1above,thefollowingrequirementsandcriteria apply to WHO’s procurement of the specifiedproducts/items.

2.2.1. Criteria for the procurement of finished pharmaceutical products (FPP)

WHO procures only FPPs which are (listedinorderofpriority):

A. Prequalified by WHO, through its ProgrammeforPrequalificationof Medicines;11 or

B. Approved by a Stringent Regulatory Authority (SRA)12ascurrentlydefinedby WHO, including those FPPs which are tentatively approved [by the US Food and Drug Administration (USFDA)] or have an Article 58 positive opinion [issued by the EuropeanMedicinesAgency(EMA)];or

C. Recommended by the Expert Review Panel (ERP)13, as coordinated by the WHO PrequalificationteamforTGF,UNFPAorUNICEF;or

D. Considered acceptable in principle for procurement by WHO based on technical data collected, the product dossier and expertriskassessment,onthebasisoftheinformationobtainedandavailablefromothersourcesandtheGMPinspection;or

11-Medicines/Finishedpharmaceuticalproducts. In:EssentialMedicinesandHealthProducts:Prequalification ofmedicines[website].Geneva:WorldHealthOrganization;2018 (https://extranet.who.int/prequal/content/prequalified -lists/medicines, accessed 23 January 2018).12-Fifty-firstreportoftheWHOExpertCommitteeonspecificationsforpharmaceuticalpreparations.Geneva:WorldHealthOrganization;2017(WHOtechnicalreport series;no.1003).Licence:CCBY-NC-SA3.0IGO. (http://www.who.int/medicines/areas/quality_safety/ quality_assurance/expert_committee/trs_1003/en/, accessed 23 January 2018).13-TheExpertReviewPanel[InformationNote09Feb2016]. Geneva:WorldHealthOrganization;2016 (https://extranet.who.int/prequal/sites/default/files/ documents/73%20ERP_Feb2016_1.pdf, accessed 23 January 2018).


E. Listed under the WHO Emergency Use Assessment and Listing procedure (EUAL) forcandidatemedicinesforuseinthecontextofapublichealthemergency.

Thefollowingdocumentsshallbesubmittedbythe supplier to WHO as evidence:

• ReferencetotheWHO-PQlistandcopy ofthelettersentbyWHO-PQtothe manufacturer;or

• ACertificateofaPharmaceuticalProduct(CPP)14 issued by a SRA, together with a summaryofproductcharacteristics(SmPC),orproofoftheofficialregistrationoftheproduct;or

• ReferencetotheERPlistofrecommendedproducts and/or the letter issued by TGF or therelevantERPclient;or

• Acertificationthattheproposedproductisexactlythesameastheprequalified/ approvedone.Ifdifferencesexistbetweenthe proposed product and the approved/registeredone(e.g.differencesinformulation, strength,shelf-lifeorotherspecificationsincludingpackaging),theyshallbeidentified andjustified.WHOwill,atitssolediscretion, determinetheeligibilityofsuchaproductforprocurementbyWHO.

All FPPs not captured by the above listed categories (A-E) will be managed by WHOthrough a technical review conducted by the QA Group using the Interagency finished pharma-

14-Certificationschemeonthequalityofpharmaceuticalproducts moving in international commerce. In: Essential medicines and health products [website]. Ge-neva:WorldHealthOrganization;2018 (http://www.who.int/medicines/areas/quality_safety/ regulation_legislation/certification/en/, accessed 23 January 2018).

ceuticalproductquestionnaire.Thisquestionnaire is basedon themodel qualityassurance system for procurement agencies (MQAS)15. WHO will, at its sole discretion, determine whether such productsareeligibleforprocurementbyWHO.

Inallcases,certificatesofanalysis,productsamples and product information including packagingand labelling shall be made available to WHO uponrequest.

2.2.2. Criteria for the procurement of biological products and vaccines

WHO procures primarily WHO prequalified vaccines.16

In exceptional circumstances, WHO may procure vaccineswhicharenotprequalifiedbyWHO. Insuch cases, in addition to a full assessment ofthe technical requirements by the QA Group, preferenceisgivento:

A. Products approved by an SRA; or

B. Manufacturers already WHO prequalified for at least one (1) biological or vaccine product;or

C. Products listed under the Emergency Use Assessment and Listing Procedure (EUAL) forcandidatevaccinesforusein thecontextofapublichealthemergency.

15-Appendix6(Interagencyfinishedpharmaceuticalproductquestionnairebasedonthemodelquality assurancesystemforprocurementagencies). (http://www.who.int/entity/medicines/areas/quality_safety/quality_assurance/MQAS-Appendix-6.docx?ua=1, accessed 24 January 2018).16-http://www.who.int/immunization_standards/vaccine_quality/pq_suppliers/en/index.htmlWHOPrequalified Vaccines[onlinedatabse].Geneva:WorldHealthOrganization; 2018 (https://extranet.who.int/gavi/PQ_Web/, accessed 24 January 2018).


Any non-pre-qualified product will be subjectto thefinalwrittenacceptanceof thebiological product / vaccine and source (manufacturer)by the recipientcountryprior to theWHOfinal procurement procedure.

For biological products (if applicable), a formal declaration is required indicating the NRA responsible for the lot release of the finishedproduct.When theproduct is ahuman-derivedblood product, the formal declaration must alsoincludetheNRAresponsiblefortheplasmapool release.

2.2.3. Criteria for the procurement of medical devices

WHO procures medical devices only if the product is:

A. Listed as WHO prequalified;or

B. Considered acceptable in principle for procurement by WHO based on techni-cal data collected, the product dossier and expert risk assessment(iftheproductisnotwithinthescopeofWHOprequalifi-cation).

Currently,fewmedicaldevicecategoriesfallwithin thescopeofWHOprequalification.Somewithinthis scope include male circumcision devices and immunization-relatedequipment.

For products in category A, aWHO Prequalifi-cation Public Report shall be submitted by the supplierasproofofthePQlisting.

For products in category B, a WHO Assessment ReportshallbesubmittedasproofoftheWHOassessment.

2.2.4. Criteria for the procurement of in vitro diagnostic medical devices (IVDs) and other laboratory items

WHOprocuresIVDsonlyiftheproductis:

A. Listed as WHO prequalified;17 or

B. Recommended by the Expert Review Panel for Diagnostics18 (ERPD), as coor-dinated by WHO Pre-qualification Team for TGF and Unitaid; or

C. Listed under the WHO Emergency Use Assessment and Listing procedure foruseinthecontextofapublichealthemergency; or

D. Considered acceptable in principle for procurement by WHO based on techni-cal data collected, the product dossier and expert risk assessment(iftheproductisnotwithinthescopeofWHOprequalifi-cation).

The WHO prequalification focusses on assessment of IVDs for certain priority diseasesand their suitability for use in resource-limited settings. Therefore, the WHO prequalification assessment is limited to certain categories ofIVDs. When the IVDcategory is subject to theWHO prequalification assessment, only WHOprequalifiedIVDsshouldbesourced.

17-WHOlistofprequalifiedinvitrodiagnosticproducts.In: In vitro diagnostics and laboratory technology [website]. Geneva:WorldHealthOrganization;2018(http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/, accessed 23 January 2018).

18-TheExpertReviewPanel[InformationNote09Feb2016]. Geneva:WorldHealthOrganization;2016(https://extranet.who.int/prequal/sites/default/files/documents/73%20ERP_Feb2016_1.pdf, accessed 23 January 2018).


When the IVD category does not fall within thescopeofPQorEUAL,anassessmentshallbemade by the relevant WHO technical unit. Such an assessment shall follow WHO guidance forprocurement of diagnostics19 through technical review of selected quality, performance and operational characteristics.

For products in category A, aWHO Prequalifi-cation Public Report shall be submitted by the supplierasproofofthePQlisting.

For products in category B, a WHO Assessment ReportshallbesubmittedasproofoftherelevantWHO technical unit’s assessment.

For products in category C, a WHO EUAL Report shallbesubmittedasproofofEUAL.

As a minimum requirement, IVDs and other laboratory items procured by WHO must be manufactured at a site in compliance with ISO13485 or an equivalent quality management system (QMS) recognized by a regulatory authorityofthefoundingmembersoftheGlobalHarmonizationWorkforce(GHTF)20.

19-Guidanceforprocurementofinvitrodiagnosticsandrelatedlaboratoryitemsandequipment.Geneva:WorldHealthOrganization;2017.Licence:CCBY-NC-SA3.0IGO.(http://apps.who.int/iris/bitstream/10665/255577/1/9789241512558-eng.pdf?ua=1, accessed 23 January 2018).20-Globalharmonizationtaskforce(GHTF). In: Medical Devices [website]. Geneva: World Health Organization;2018(http://www.who.int/medical_devices/collaborations/force/en/, accessed 23 January 2018).


3. REQUIREMENTS FOR SUPPLIERS OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS TO WHO

3.1. Definitions of supplier and requirements for all suppliers

For the purposes of this Policy, a supplier of essential medicines or other health products to WHO is either (i) a wholesale distributor, which is anintermediarywhichdoesnotmanufacturetheproduct,or(ii)themanufactureroftheproduct.Specific requirements forwholesale distributorsandmanufacturers,respectively,follow.

In order to be a potential supplier of essentialmedicines and other health products to WHO, suppliers must:

i. abidebytheUNSupplierCodeofConduct21;ii. acceptthetermsoftherelevantprocurement

solicitationdocuments(RFPorotherwise);iii. be registered in the United Nations Global

Marketplace(UNGM);andiv. comply with this Policy, as applicable.

21-UNSupplierCodeofConduct.NewYork: UNProcurementDivision;2017 (https://www.un.org/Depts/ptd/about-us/ un-supplier-code-conduct).

3.2. Requirements for wholesale distributors

In addition to the provisions in Section 3.1 above, wholesale distributors supplying essential medicines and other health products to WHO must:

A. have all requisite authorizations in their country of operation, delivered by their NRA or other entity as required by local legislation. Acopyofanyvalidlicense, permit, or authorization shall be provided22;and

B. comply with the WHO Good Distribution Practices (GDP) / Good Storage Practices (GSP)23 and with the requirements of the WHO MQAS.24Thisrequirementalso includestheconcernedpremisesofthewholesale distributor. For GDP and GSP, standardsfromUSFDAandEUareaccepted. Avalidcopyofthecertificateordocumentattestingofthiscomplianceshallbeprovided. Suchcertificate/documentshallbeissuedbyaSRA;and

C. complete the WHO wholesaler distributor informationquestionnaireforreviewandapproval by WHO QA Group.

22-Wholesaledistributorscanhavemultiplepremises,locatedindifferentsitesorevendifferentcountries. Allpremisesshallbedulyauthorizedandacopyofthelicense,permitetc.foreachoftheoperatingpremises engagedinanyfunctionoftheproposedprocurementmust be provided.23-Guidelines.In:Essentialmedicinesandhealthproducts[website].Geneva:WorldHealthOrganization;2018 (http://www.who.int/medicines/areas/quality_safety/ quality_assurance/guidelines/en/, accessed 23 January 2018).24-Amodelqualityassurancesystemforprocurementagencies.Geneva:WorldHealthOrganization;2007 (WHO/PSM/PAR/2007.3) (http://www.who.int/medicines/publications/ ModelQualityAssurance.pdf, accessed 23 January 2018)


WHOreservestherighttoauditthesite(s)ofthewholesaledistributortoverifythecomplianceoftheir QA system with the standards in this Policy. The observations and conclusions of the auditpertain exclusively to the audited premises and cannot be extrapolated to other premises (as per the MQAS25).

Forspecialcases,suchasapprovalofawholesaledistributorforkitsupply,theauditsalsoaddresstheabilityofthewholesaledistributortoperformthe proposed activities according to applicable standards, such asWHOGSP/GDP.A list of theaudited wholesale distributors is maintained by theWHOQAofficer.

25-AnnexThree.In:ModelQualityAssuranceSystemforProcurementAgencies.Geneva:WorldHealthOrganization;2014(WHOtechnicalreportseries;no.986). (http://apps.who.int/medicinedocs/en/m/abstract/Js21492en/, accessed 23 January 2018).

WHO’s waiver of audits of wholesale distributors

WHO reserves the right to accept the audit of a wholesale distributor performedbyanotherUNsystemorgan-ization. In such cases, the whole-saler’s compliance will be accepted by WHO ifWHOdeterminesthattheaudit:

• Is conducted less than three years fromthedateoftheproposed procurement;

• Assesses the same premises and similar products supplied to WHO by the wholesale distributor (name and address shall be identifiedwithnoambiguity);

• SatisfiestherequirementsofWHOregardingtheselectionoftheauditor (expertise and independence), the standards used [WHO (orequivalentGDP/GSPand WHO MQAS)] and the audit management (according to its writtenSOPs);

• Concludes that the wholesale distributor operates at an acceptable levelofcompliance with the WHO GDP and/or the WHO MQAS (the report or at least the conclusions andthelistoftheobservations noted during the audit must be madeavailabletoWHO);and

• Includesasignedstatementfromthe wholesale distributor that no majorchangeshavebeenmade topremises,equipmentandkey personnel since the audit.


3.3. Requirements for manufacturers

In addition to the provisions in Section 3.1 above, the following requirements apply to manufac-turers supplying essential medicines and other health products to WHO:

A. Manufacturers must be duly authorized by the NRA in the country of origin. Acopyofthevalidlicensemustbeprovided. Thelicensemustunequivocallystipulatethetypesofactivitiesthatareauthorizedintheproductionfacilities.Acopyofthelicenseforeachproductionsitewhere proposed products are produced must alsobeprovided;AND

B. Manufacturing sites must be GMP compliant as inspected by WHO, an SRA or a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Asproofofcompliance,themanufacturershallprovidereferencetotheWHOPublicInspection Report (WHOPIR) published on the WHO PQPwebsite,oracopyoftheGMPcertificateorapprovalletter(forUSFDA)delivered by a SRA/PICs member.

In addition, the manufacturers (or their representatives) shall submit informationabout each concerned manufacturing site and production unit, by sharing a copy of a recentsitemasterfile(SMF)oracompletingatechnical questionnaire (see Annex 4 of the TechnicalQuestionnaireforpharmaceuticalmanufacturers,WHO MQAS 2014).

In absence of proof of compliance with WHO (orequivalent)GMPcompliance,WHOreserves the right to organize a GMP audit against the WHO guidelines. WHO will contract independent qualifiedexpertstoperformanaudit.

WHO waivers of audits of suppliers

WHO reserves the right to accept the au-dit of a supplier performed by another UN system organization. In such cases, the manufacturer’s GMP compliance will be accepted by WHO if WHO determines that the audit:

• Is conducted less than three years fromthedateoftheproposed procurement;

• Assesses the same premises and similar products proposed by the manufacturer(nameandaddressshallbeidentifiedwithnoambiguity);

• SatisfiestherequirementsofWHOregardingtheselectionofauditorsintermsofexpertise,independenceand the standards used (i.e. WHO or EU,USFDA)standardsforGDP/GSPandMQAS);

• Concludesthatthemanufacturingsite operates at an acceptable level ofcompliancewiththeWHOGMP(the report or at least the conclusions andthelistoftheobservations noted during the audit must be madeavailabletoWHO);and

• Includesasignedstatementfromthemanufacturerthatnomajorchanges have been made to premises,equipmentandkey personnel since the audit.


3.4. Accepting a potential supplier of essential medicines and other health products which is not pre-qualified under the WHO Prequalification Programme

In the event that a manufacturer or wholesaledistributor is not prequalified under the WHOPrequalificationProgramme,itmaybeaccepted as compliant with this Policy if the QA Grouphasperformedariskassessmentofthesupplier, basedonauditreportsandrelevantinformation collectedfromWHOorrecognisedorganizations (otherUN agencies andmember of the Intera-gency Pharmaceutical Group), and determined that the manufacturer/wholesale distributormeetsthequalificationstandardsassetforthinthis Policy.

When the manufacturer/wholesale distributor is found by WHO to meet the qualification standards, it is included in the list of potentialWHO suppliers for the range of products forwhich the supplier was assessed.

Suppliers who have been accepted in principle underthisPolicymustagreetothefollowing:

• ToinformWHOincaseofanychangeinthesafetyprofile(specifications,stability,qualitymanagementsystem,etc.)ofthesuppliedproduct(s);

• TorequestWHO’sacceptanceofanychangein the products source as agreed in the qualificationprocessbeforemakingsuchchanges;

• ToinformWHO,throughitsProcurementDepartment, immediately about any serious qualityand/orsafetyconcernsaboutthemanufacture,controloruseofthesuppliedproducts,andsuspensionorcancellationof

• marketingauthorizations;and,inthecaseofIVDs,toconductfieldsafetycorrectiveactions(fieldsafetynotices);26

• To work with WHO to minimize potential public health risks by actively organizing productrecallsofdefectiveproductsbyeitherreplacingthedefectiveproductorcovering the direct and related costs related tothereplacinganddestroyingofthe defectiveproduct.

3.5. Removal of Suppliers

WHO may, at its discretion, remove a suppli-er from the WHO list of accepted-in-principle suppliersofessentialmedicinesandotherhealthproducts, includingdue to the supplier’s failureto comply with this Policy.

26-Post-marketsurveillanceforinvitrodiagnostics(IVDs).In: In vitro diagnostics and laboratory technology [website]. Geneva:WorldHealthOrganization;2018. (http://www.who.int/diagnostics_laboratory/postmarket/en, accessed 23 January 2018).


4. MONITORING THE QUALITY OF ESSENTIAL MEDICINES AND OTHER HEALTH PRODUCTS PROCURED BY WHO, AND SUPPLIERS THEREOF

4.1. Monitoring of suppliers’ performance

At least every three years, WHO will conduct the technical monitoring of suppliers considered acceptableinprincipleforprocurementbyWHO.Thisincludesareviewofupdateddocumentationandatechnicalvisitorre-auditofthesupplier’spremises in accordance with the WHO guidelines (GMP,GDP,MQAS).TheworkandfindingsofSRA/WHO-PQ and other recognized organizations (OtherUNAgenciesandmemberof the Intera-gency Pharmaceutical Group) will be considered. In addition, WHO closely monitors the performance of the suppliers against a set ofmeaningful and measurable key performance indicators (KPIs) when such KPIs are defined inthe contract between the supplier and WHO.

4.2. Quality testing of essential medicines and other health products

Suppliers consideredacceptable inprinciple forprocurement by WHO shall submit to WHO the results of their own quality control laboratorytests for each batch of essentialmedicines andhealth products procured by WHO.

4.2.1. Pre-shipment and post-shipment quality monitoring

WHO independently monitors the quality of the essential medicines and health products procuredbytheOrganizationatdifferentpointsof the supply chain. The quality control testingis carried out according to sampling and testing protocols and standard operating procedures.27

WHO reserves the right to assign an independent WHO Quality Control Laboratory (QCL) to test batches.Thetestingmayoccuratanystageofthesupplychainandisaimedatassessingthequal-ity of essential medicines and health products. Toensurethequalityofindependentqualitycontrol testing, WHO only uses QCL services that are WHOprequalified28 or accredited in accordance withISO17025.

In addition, suppliers shall report to WHO any informationavailabletothemregardingachangein safety profile of the suppliedpharmaceuticalproducts. WHO reserves the right to be in contact withNRAs concerning issues related to quality,safety and efficacy of procured pharmaceuticalor other health products, and may participate inpost-deliverymonitoringactivities incollabo-ration with NRAs and other recognized organi-sations (otherUNAgenciesandmemberof theInteragency Pharmaceutical Group) as needed.

27-Annex4(Considerationsforrequestinganalysisofdrugsamples).In:Thirty-sixthreportoftheWHOExpertCommitteeonspecificationsforpharmaceutical preparations.Geneva:WorldHealthOrganization;2002(WHOtechnicalreportseries;no902) (http://www.who.int/medicines/areas/quality_safety/ quality_assurance/ConsiderationsRequestingAnalysesDrug-SamplesTRS902Annex4.pdf?ua=1, accessed 24 January 2018).28-MedicinesQualityControlLaboratories.In:EssentialMedicinesandHealthProducts:Prequalificationofmedicines [website].Geneva:WorldHealthOrganization;2018 (https://extranet.who.int/prequal/content/medicines-quali-ty-control-laboratories-list, accessed 24 January 2018).


4.2.2. Criteria for the sampling plan

The sampling plan is established in line with relevant WHO technical references29 and risk assessment. The sampling will depend on the following:

• ThelevelofGMPcomplianceofthemanu-facturer;

• Thecriticalityoftheproducts(anti-infective,injections,FixedDoseCombinations(FDC),productswithknownstabilityproblems,etc.);

• Thepotentialriskforfalsification;• Thequalityproblemsreportedduringthe

pasttwoyears;• Anyspecificrequirementsfromthelocal

authorities;• Recentlyapprovedproducts;and/or• Productspurchasedinhighquantities.

4.3. Managing quality non-conformity

IntheeventthatWHO-designatedindependent QCLs, either during pre-shipment or post- shipment testing, return results that are non- conforming to specifications as per indicatedpharmacopoeiastandards,themanufacturerwillbe required to investigate the discrepancy andprovide a report. The investigations shall include testingoftheretainedsample.

29-Annex4(WHOguidelinesforsamplingof pharmaceutical products and related materials). In:Thirty-ninthreportoftheWHOExpertCommitteeonspecificationsforpharmaceuticalpreparations.Geneva:WorldHealthOrganization;2005(WHOtechnicalreportseries;no929) (http://www.who.int/medicines/areas/quality_safety/quali-ty_assurance/GuidelinesSamplingPharmProductsTRS929An-nex4.pdf?ua=1, accessed 24 January 2018).

4.4. Suppliers’ responsibility for rejected or returned products

Incaseofconfirmednon-compliance,eitherinthequality,performance,safetyoftheproductorinagreed packaging or labelling, the supplier must replace promptly and effectively the complete batch at the supplier’s own cost (including product recall, and other field safety corrective actions,product replacement, freight and re-inspectioncost) and take appropriate actions to eliminate riskstothehealthofusers.

Depending on the nature of non-compliance, the replacement from the same source mayno longer be acceptable. In such a case, WHO reserves the right to cancel or terminate the contract with the supplier (in addition to other rights, such as the right to claim damages) and/or remove the supplier from the WHO list of accepted-in-principle suppliers of essential medicines and other health products


Formoreinformation:http://www.who.int/about/finances-accountability/procurement/en/

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