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Female Condom Generic Specification, Prequalification Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012 The following organizations support the use of the WHO/UNFPA Female Condom Generic Specification: The Global Fund to Fight AIDS, Tuberculosis and Malaria FHI360 International Planned Parenthood Federation/CONtraceptive and SRH Marketing LTD (IPPF/ICON) I + Solutions 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 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) Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012 WHO/UNFPA Female Condom Generic Specification, Prequalification and Guidelines for Procurement, 2012 © World Health Organization, United Nations Population Fund and FHI360, 2012 All rights reserved. Publications of the World Health Organization can be obtained from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications— whether for sale or for non commercial distribution—should be addressed to WHO Press, at the above address (fax: +41 22 791 4806; e-mail: [email protected]). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization and UNFPA concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundar- ies. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization and UNFPA in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization, UNFPA and FHI360 to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization and UNFPA be liable for damages arising from its use. WHO/UNFPA Female Condom Generic Specification, Prequalification and Guidelines for Procurement 2012. 1. Condoms - supply and distribution. 2. Condoms - standards. 3. Quality control. 4. Product packing - standards. 5. Contraceptive devices, Female. 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. FHI360. Photo credits: Front cover (left to right): Morten Sorensen/UNFPA; Morten Sorensen/UNFPA; © Win Morgan, Courtesy of Photoshare Chapter 1: © Win Morgan, Courtesy of Photoshare Chapters 2-4, 6-9: Morten Sorensen/UNFPA Chapter 5: © 1999 Sandhya Rao, RPLM, JSI, courtesy of Photoshare Chapter 10: UNFPA PSB Annexes: © Center for Communication Programs, Courtesy of Photoshare Back cover (left to right): Morten Sorensen/UNFPA, Morten Sorensen/UNFPA, © Center for Communication Programs, Courtesy of Photoshare 2 Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012 CONTENTS ACKNOWLEDGEMENTS 6 INTRODUCTION 8 PART ONE: FEMALE CONDOM – QUALITY ASSURANCE AND WHO/UNFPA SPECIFICATION 11 Chapter 1: Introduction 13 1.1 General 13 1.2 Basis for the WHO/UNFPA Female Condom Generic Specification 14 1.3 Clinical Investigation 14 1.3.1 Contraceptive Efficacy Study 15 1.3.2 Functionality study against a equivalent marketed product 15 Table 1 Risk Assessment – Factors to be considered when considering equivalence for assessing clinical evaluation requirements 16 1.4 Setting the Specification for Specific Products 17 1.4.1 Airburst properties 17 1.4.2 Other Requirements 18 1.5 Data sheets 18 1.6 Lot 18 1.7 Lot-by-Lot Pre-shipment compliance testing 19 1.8 Sampling 19 1.9 Acceptable Quality Limit (AQL) 20 1.10 Monitoring Quality 20 1.11 Testing Laboratories 20 1.12 Testing costs 21 1.13 Confirmatory testing 21 Chapter 2: Details of the WHO/UNFPA Female Condom Generic Specification 25 2.1 Table 2 General Requirements 25 2.2 Table 3 Performance Requirements 28 2.3 Table 4 Design Requirements 29 2.4 Table 5 Packaging Requirements for Shipment 32 Chapter 3: Summary tables: Prequalification and Lot-by-Lot testing 37 Table 6 Summary of Prequalification Tests 37 Table 7 Summary of Lot-by-Lot Pre-shipment compliance testing and requirements 38 Chapter 4: Workmanship and Visible Defects 41 4.1 Introduction 41 4.2 Types of visible defects in condoms 41 4.2.1 Critical Visible defects 41 Table 8 Critical visible defects—AQL 0.4 41 4.2.2 Non-critical visible defects 42 Table 9 Non-critical visible defects—Recommended AQL 2.5 42 4.2.3 Imperfections 42 Table 10 Imperfections that are not regarded as defects 42 4.3 Packaging defects 43 4.3.1 Individual packages 43 4.3.2 Consumer packs 43 4.3.3 Cartons and Marking 43 Table 11 Packaging defects 43 Chapter 5: Resolution of disputes related to product quality 47 5.1 Introduction 47 5.2 Disputes over laboratory results 47 5.3 Source of disputes arising from laboratory testing 47 5.4 Decisions on re-testing 48 Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012 3 5.5 Re-testing 48 5.5.1 Independent testing laboratory 49 5.5.2 Manufacturer 49 Chapter 6: Bioburden and Microbial Control 53 6.1 Introduction 53 6.2 Bioburden, limits and rationale 53 6.2.1 Bioburden 53 6.2.2 Condom bioburden limits 53 6.2.3 Rationale 53 6.3 Test methods 54 6.3.1 Routine monitoring 54 6.3.1.1 Surface testing 54 6.3.1.2 Powders and liquids 55 6.3.1.3 Air sampling 55 6.3.1.4 Identification of micro-organisms 56 6.3.1.5 Rapid test methods 56 6.4 Guidance for controlling microbial contamination 56 6.4.1 Equipment 56 6.4.2 Environment 56 6.4.3 Personnel 56 6.4.4 Raw materials 56 6.4.4.1 Water 57 6.4.5 Dipping, stripping and drying 57 6.4.6 Slurry treatment 57 6.4.7 Testing, lubrication and packaging 57 References 58 Chapter 7: Test methods 63 7.1 Testing for Bursting Volume and Pressure 63 7.2 Testing for Freedom from Holes and Visible Defects 63 7.3 Testing for Package Seal Integrity 64 7.4 Determining the Width of the Female Condom 64 7.5 Determining the Length of the Female Condom 65 7.6 Determining the Thickness of the Female Condom 65 7.7 Determining the Quantity of Lubricant (Including Powder) 65 Chapter 8: Guidelines on the Assessment of Odour 69 PART TWO: WHO/UNFPA FEMALE CONDOM PREQUALIFICATION SCHEME — FEMALE CONDOM PREQUALIFICATION, TECHNICAL REVIEW PROCESS, PRODUCT DOSSIER (PD) AND SITE MASTER FILE SUMMARY (SMF) Chapter 9: Female Condom Prequalification 73 9.1 Introduction 74 9.2 Elements of the Prequalification Process 74 9.2.1 Invitation for Expression of Interest 74 9.2.2 Data and information to be submitted 74 9.2.3 Process for submitting documentation 75 9.2.4 The Technical Review Process 75 9.2.5 Submission of Technical Information 76 9.3 Clinical Investigation 76 9.3.1 Contraceptive Efficacy Study 77 9.3.2 Functionality study against an equivalent marketed product 77 9.4 Preparation of a Product Dossier 78 9.4.1 Characteristics of the products 78 9.4.2 Local, country & regional regulatory product approvals 78 9.4.3 Raw materials 78 4 Female Condom: Generic Specification, Prequalification and Guidelines for Procurement, 2012 9.4.4 Supplier(s) 78 Table 12 Primary materials of construction and compounding ingredients (if relevant) 78 9.4.5 Sites of manufacture 79 9.4.6 Risk management of the product 79 9.4.7 Specifications for the finished products 79 9.4.8 Evidence of compliance with WHO/UNFPA’s General Requirements 79 9.4.9 Stability data 79 9.4.10 Labelling and additional information 79 9.5 Samples 80 9.6 Preparation of the Site Master File Summary 80 9.6.1 General information 80 9.6.2 Manufacturing certifications 80 9.6.3 Personnel 81 9.6.4 Premises and equipment 81 9.6.5 Documentation 81 9.6.6 Records 81 9.6.7 Production 81 9.6.8 Risk management plan 82 9.6.9 Quality control 82 9.6.10 Distribution, complaints and product recall 82 9.6.11 Self-inspection (internal audits) 82 9.6.12 Corrective and preventative action 82 9.6.13 Design and development 82 9.7 Scope of Manufacturing Site Inspections 82 Table 13 Inspection checklists 83 9.8 Product Testing 86 9.9 Reporting and communication of the results of the site inspection 87 9.10 Decision to prequalify 87 9.11 Listing of prequalified female condom manufacturing sites 88 9.12 Maintenance of prequalification status 88 9.13 Periodic monitoring of the quality of products produced by prequalified manufacturing sites 89 9.14 Reassessment 89 PART THREE: GUIDELINES FOR PROCUREMENT, SPECIFICATION AND PROCUREMENT CHECKLISTS Chapter 10: Specification and Procurement Checklists 93 10.1 Introduction 93 10.1.1 Comprehensive Condom Programming 93 10.2 Procurement 94 Table 14 Three Phases and 10 steps of Procurement 94 10.2.1 Notes on Country registration 95 Table 15 WHO/UNFPA Specification
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