Male Latex Condom : Specification, Prequalification and Guidelines for Procurement, 2010 Procurement, and Guidelines for Prequalification Specification, Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 revised April 2013 This document has been prepared in consultation with representatives from: U.S. Agency for International Development (USAID) • Department for International Development (DFID) • World Bank • U.S. Centers for Disease Control and Prevention • Crown Agents • International Standardization Organization (ISO) Technical Committee 157 • John Snow, Inc. (JSI) • Program for Appropriate Technology in Health (PATH) • Population ISBN 978 92 4 159990 0 Services International (PSI) • Population Action International (PAI) Department of Reproductive Health and Research Family and Community Health World Health Organization The following organizations support the use of the WHO/UNFPA Male Latex Condom Specification and Prequalification Scheme. The Global Fund to Fight AIDS, Tuberculosis and Malaria Family Health International (FHI) International Planned Parenthood Federation/International CONtraceptive & SRH Marketing Ltd. (IPPF/ICON) Marie Stopes International (MSI) John Snow, Inc. (JSI) Joint United Nations Programme on HIV/AIDS (UNAIDS) PATH Partners in Population and Development (PPD) Population Action International (PAI) Population Services International (PSI) Reproductive Health Supplies Coalition (RHSC) United Nations Population Fund (UNFPA) World Health Organization, Department of Reproductive Health and Research (WHO/RHR) Male Latex Condom Specification, Prequalification and Guidelines for Procurement, 2010 Department of Reproductive Health and Research Family and Community Health World Health Organization Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 © World Health Organization, UNFPA and Family Health International, 2010 updated April 2013 All rights reserved. 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Printed in the United States of America WHO Library Cataloguing-in-Publication Data Male latex condom specification, prequalification and guidelines for procurement, 2010. 1.Condoms - supply and distribution. 2.Condoms - standards. 3.Quality control. 4.Product packing - standards. 5.Contraceptive devices, Male. 6.Sexually transmitted diseases - prevention and control. 7.HIV infections - prevention and control. I.World Health Organization. II.UNAIDS. III.United Nations Population Fund. IV. Family Health International. ISBN 978 92 4 159990 0 (NLM classification: WJ 710) CONTENTS Help-LINE 10 ACKNOWLEDGEMENTS 7 FOREWORD 8 INTRODUCTION 11 SECTION ONE: THE MALE LATEX CONDOM: QUALITY ASSURANCE AND WHO/UNFPA SPECIFICATION Chapter 1: Condom Quality Assurance 15 1 Standards 15 2 Specifications 16 3 WHO/UNFPA Prequalification Scheme 16 4 Procurement 16 5 Regulatory authorities 17 6 Manufacturing quality management 17 7 LOTS 18 8 LOT-by-LOT Pre-shipment compliance testing 19 9 Sampling 19 10 Acceptable Quality Limit (AQL) 20 11 Monitoring quality 20 12 Testing laboratories 20 13 Testing costs 21 14 Confirmatory testing 21 Chapter 2: WHO/UNFPA Specification for Male Latex Condoms 25 1 Introduction 25 2 WHO/UNFPA Specification 27 2.1 General Requirements 27 2.2 Performance Requirements 29 2.3 Design Requirements 31 2.4 Packaging for shipment 34 Table 1. Classification of defects in packaging and marking of packaging for delivery 36 Table 2. Summary of prequalification tests and requirements 37 Table 3. Summary of LOT-by LOT Pre-shipment compliance testing and requirements 38 Chapter 3: Workmanship and Visible Defects 41 1 Introduction 41 2 Types of visible defects 41 2.1 Critical visible defects 41 2.2 Non-critical visible defects 42 2.3 Imperfections 42 3 Packaging defects 42 Table 4. Critical visible defects 41 Table 5. Non-critical visible defects 42 Table 6. Imperfections that are not regarded as defects 42 Table 7. Packaging defects 43 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 3 Chapter 4: Resolution of Disputes 47 1 Introduction 47 2 Disputes over laboratory results 47 3 Sources of disputes arising from laboratory testing 47 4 Decisions on re-testing 48 5 Re-testing 48 5.1 Independent testing laboratory 49 5.2 Manufacturer 49 SECTION TWO: WHO/UNFPA MALE LATEX CONDOM PREQUALIFICATION SCHEME AND OPERATIONAL GUIDANCE Chapter 5: Male Latex Condom Prequalification Scheme 53 1 Introduction 53 1.1 Background 53 1.2 Objectives 53 2 The Prequalification Scheme for male latex condoms 53 2.1 Eligibility to participate 53 2.2 Expression of Interest 54 2.2.1 Calls for and submission of Expressions of Interest 54 2.2.2 Assessment of documents submitted 54 2.2.2.1 Initial screening of documentation 54 2.2.2.2 Assessment of the Product Dossier and the Site Master File summary 55 2.3 Site inspection 55 2.3.1 Inspection team 55 2.3.2 Scope and scheduling 56 2.3.3 Transparency 56 2.4 Product testing 56 2.5 Reporting and communication of the results of the site inspection 57 2.6 Decision to prequalify 57 2.7 Listing of prequalified male latex condoms and manufacturing sites 58 2.8 Maintenance of the prequalification status 59 2.9 Periodic monitoring of product quality produced by prequalified manufacturing sites 59 2.10 Reassessment 60 2.11 Language 60 2.12 Fees 60 2.13 Resolution of disputes 61 3 Confidentiality undertaking 61 4 Conflict of interest 61 Chapter 6: Operational Guidance—Male Latex Condom WHO/UNFPA Prequalification Scheme 65 1 Introduction 65 1.1 Invitation for Expression of Interest 65 1.2 Data and information to be submitted 66 1.3 Process for submitting documentation 66 1.4 Sample of the letter of application 67 1.5 Assessment of documents submitted 68 2 Preparation of a Product Dossier 68 2.1 Characteristics of the products 68 2.2 Samples 69 2.3 Local, country and regional regulatory approvals for the products 69 2.4 Raw materials 69 2.5 Supplier(s) 69 4 Male Latex Condom: Specification, Prequalification and Guidelines for Procurement, 2010 2.6 Sites of manufacture 69 2.7 Risk management of the product 69 2.8 Specifications for the finished products 69 2.9 Evidence of compliance with WHO/UNFPA’s General Requirements 69 2.10 Stability data 70 2.11 Labelling and additional information 70 3 Preparation of a Site Master File summary 70 3.1 General information 70 3.2 Manufacturing certifications 71 3.3 Personnel 71 3.4 Premises and equipment 71 3.5 Documentation 72 3.6 Records 72 3.7 Production 72 3.8 Risk management plan 72 3.9 Quality control 72 3.10 Distribution, complaints and product recall 72 3.11 Self-inspection (internal audits) 72 3.12 Corrective and preventive action 72 3.13 Design and development 72 4 Scope of manufacturing site inspections 72 5 Product testing 78 Table 8. Inspection guide 73 SECTION THREE: GUIDELINES FOR PROCUREMENT Chapter 7: Guidelines for Procurement 81 1 Introduction 81 1.1 Comprehensive Condom Programming 81 1.2 Procurement 81 Ten steps in the procurement process 82 Phase 1: Programme planning 82 1 Step 1: Define supply requirements 82 1.1 Define programme context 82 1.2 Forecast programme requirements 83 2 Step 2: Customize the specification 85 2.1 Review the WHO/UNFPA Specification 85 2.2 General Requirements 85 2.3 Performance Requirements 85 2.4 Design Requirements 85 2.5 Packaging Requirements 85 2.6 Consumer packs or additional requirements 85 3 Step 3: Assessment of procurement options 86 3.1 Select a procurement method 86 3.1.1 Procure directly from a manufacturer through a competitive bidding process 86 3.1.2 Source from a procurement agency 87 3.1.3 Source from an international procurement agency/organization 87 3.1.4 Buy from a social marketing organization 88 4 Step 4: Budget, funding and procurement requisition 89 4.1 Estimating