WHO Sample product dossier for SIMU™self-test for HIV 12O WHO Prequalification: Sample Product Dossier for an IVD intended for HIV self-testing SIMU™ self-test for HIV 12O PQDx5432-98-00 THE Manufacturing Company DRAFT DOSSIER FOR PUBLIC COMMENT Disclaimer This Product Dossier is entirely fictitious and has been produced for illustrative purposes only. Each manufacturer must determine what should be submitted to fulfil WHO requirements. Working document 21 December 2015 WHO Sample product dossier for SIMU™self-test for HIV 12O © World Health Organization 2015 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]). 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Contact: Irena Prat, EMP Prequalification Team Diagnostics WHO - 20 Avenue Appia - 1211 Geneva 27 Switzerland Working document 21 December 2015 WHO Sample product dossier for SIMU™ self-test for HIV 12O Table of contents Abbreviations ............................................................................................... 7 1 Introduction .................................................................................... 9 1.1 Purpose of the sample product dossier .......................................................................9 1.2 Content of the sample product dossier........................................................................9 1.3 Completeness of the sample product dossier ..............................................................9 1.4 Format of the sample product dossier .........................................................................9 1.5 Feedback on the sample product dossier .....................................................................9 2 Intended audience ......................................................................... 10 3 The product dossier ....................................................................... 11 3.1 WHO product dossier elements ................................................................................ 11 3.2 When to submit a product dossier ............................................................................ 11 4 WHO Product Dossier checklist ...................................................... 12 5 The product ................................................................................... 20 5.1 Regulatory versions of this product ........................................................................... 20 5.2 Product description including variants (configurations) and accessories ..................... 20 5.2.1 Product description .............................................................................................. 20 5.2.2 Intended use ........................................................................................................ 22 5.2.3 Intended users ..................................................................................................... 22 5.2.4 Photographs of kit ................................................................................................ 22 5.2.5 A general description of the principle of the assay method or instrument principles of operation. ........................................................................................ 23 5.2.6 A description of the components of the assay .................................................... 24 5.2.7 A description of the specimen collection and transport materials provided with the product or descriptions of specifications recommended for use. ........ 24 5.2.8 For instruments of automated assays: a description of the appropriate assay characteristics or dedicated assays ............................................................ 24 5.2.9 For automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation. ..................................................... 24 5.2.10 If applicable, a description of any software to be used with the product. .......... 24 5.2.11 If applicable, a description or complete list of the various configurations or variants of product that will be made available .................................................. 25 5.2.12 If applicable, a description of the accessories and other products that are intended to be used in combination with the diagnostic .................................... 25 5.3 Essential principles (EP) check list ............................................................................. 25 5.4 Risk analysis and control summary............................................................................ 25 5.4.1 Risk analysis policy ............................................................................................... 25 5.4.2 Risk Categories ..................................................................................................... 26 5.4.2.1 Erroneous test results ........................................................................... 26 5.4.2.2 Interfering substances .......................................................................... 27 5.4.2.3 Testing process ..................................................................................... 27 5.4.2.4 Stability ................................................................................................. 27 Working document 21 December 2015 Page 3 of 165 WHO Sample product dossier for SIMU™ self-test for HIV 12O 5.4.2.5 Specimen type ....................................................................................... 28 5.4.3 Risk/Benefit .......................................................................................................... 28 6 Design and manufacturing information ......................................... 29 6.0 Design control .......................................................................................................... 29 6.1 Product design ......................................................................................................... 30 6.1.1 Design overview ................................................................................................... 30 6.1.2 Formulation and composition .............................................................................. 32 6.1.3 Biological safety ................................................................................................... 33 6.1.4 Documentation of design changes ....................................................................... 34 6.2 Manufacturing process ............................................................................................. 35 6.2.1 Overview of manufacture .................................................................................... 35 6.2.1.1 Batch release criteria/Final lot release ................................................. 36 6.2.2 Sites of manufacture ............................................................................................ 37 6.2.3 Key suppliers ........................................................................................................ 38 7 Product performance specifications and associated validation and verification studies. ................................................ 39 7.0 QC panel for SIMU™ self-test for HIV 12O Product Codes: Y1234-B and Y1234-O ..... 41 7.0.1 Validation of the QC calibrator scale for use in stability studies and at release-to-sale ...................................................................................................... 41 7.0.1.1 Introduction .......................................................................................... 41 7.0.1.2 Study objective ...................................................................................... 41 7.0.1.3 Study design and planning .................................................................... 42 7.0.2 QC panel members, criteria, rationale ................................................................. 45 7.0.2.1 QC panel for SIMU™ self-test for HIV 12O Product Codes: Y1234-B and Y1234-O ........................................................................................