SAMPLE PRODUCT DOSSIER - WHO

1 CONTACTD epartment of Essential Medicines and Health TechnologiesWorld Health Organization20 Avenue AppiaCH-1211 Geneva 27 SwitzerlandE-mail: Prequalification DiagnosticsSAMPLE PRODUCT DOSSIER for WHO PrequalificationSimu POC CD4 SystemTHE Manufacturing Company SAMPLE DOSSIERDISCLAIMERThis SAMPLE PRODUCT DOSSIER is entirely fictitious and has been produced for illustrative purposes only. Each manufacturer has to determine what documentation has to be submitted to fulfill WHO Prequalification DiagnosticsSAMPLE PRODUCT DOSSIERfor WHO PrequalificationSimu POC CD4 SystemTHE Manufacturing Company PQDx_170:WHO SAMPLE PRODUCT DOSSIER - POC CD4 World Health Organization 2014 All rights reserved. Publications of the World Health Organization are available on the WHO web site ( ), World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland.

2 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 concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization 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 reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication.

3 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 be liable for damages arising from its use. Layout by L IV Com S rl, Villars-sous-Yens, 31. Introduction Purpose of the SAMPLE PRODUCT DOSSIER Content of the SAMPLE PRODUCT DOSSIER Completeness of the SAMPLE PRODUCT DOSSIER Format of the SAMPLE PRODUCT DOSSIER Feedback of the SAMPLE PRODUCT DOSSIER 52. Intended Audience 53. The PRODUCT DOSSIER WHO PRODUCT DOSSIER elements When to submit a PRODUCT DOSSIER 54. WHO PRODUCT DOSSIER Checklist 65. The PRODUCT Regulatory versions of this PRODUCT PRODUCT description including variants (configurations) and accessories PRODUCT Description Intended Use: Intended User: A general description of the principle of the assay method or instrument principles of operation A description of the components of the assay A description of the specimen collection and transport materials provided with the PRODUCT or descriptions of specifications recommended for use For instruments of automated assays: a description of the appropriate assay characteristics or dedicated assays For automated assays.

4 A description of the appropriate instrumentation characteristics or dedicated instrumentation If applicable, a description of any software to be used with the PRODUCT If applicable, a description or complete list of the various configurations/variants of PRODUCT that will be made available If applicable, a description of the accessories, and other products that are intended to be used in combination with the diagnostic Essential principles (EP) checklist Risk analysis and control summary Simu POC CD4 System Residual Risk Statement 156.

5 Design and Manufacturing Information PRODUCT design and manufacture Design overview Formulation and composition Biological Safety Documentation of design changes Manufacturing processes Overview of manufacture Sites of manufacture Key suppliers 237. PRODUCT Performance Specification, and Associated Validation 2 THE MANUFACTURING COMPANY 1 SIMU POC CD4 SYSTEMWHO PREQUALIFICATION - SAMPLE DOSSIERand Verification Studies 25 Section 7 Summary: Analytical studies Specimen type Analytical performance characteristics Stability (excluding specimen stability) Claimed Shelf-Life Simu POC CD4 System Cartridges and Simu POC CD4 System Control Cells. In use stability Shipping stability Software verification and validation Clinical Evidence Clinical evaluation Manufacturer Clinical evaluation Independent studies 488.

6 Labelling Labels Instructions for use 579. Commercial History Countries of supply Adverse events and field safety corrective actions History 6411. Quality Management System Quality manual Quality manual system documents Quality manual system certificates 65 ANNEX 1 ESSENTIAL PRINCIPLES CHECKLIST 66 ANNEX 2 THE MANUFACTURING COMPANY DOC XXX RISK MANAGEMENT POLICY 82 ANNEX 3 Simu POC CD4 SYSTEM DESIGN INPUT FMEA 84 ANNEX 4 Simu POC CD4 SYSTEM USER AND PATIENT FMEA 87 ANNEX 5 Simu POC CD4 SYSTEM PROCESS FMEA 91 ANNEX 6 Simu POC CD4 SYSTEM SUPPLIER MANAGEMENT FMEA 91 ANNEX 7 DESIGN INPUT REQUIREMENTS 92 ANNEX 8 THE MANUFACTURING COMPANY QUALITY MANUAL 973 ABBREVIATIONSCD4 cluster of differentiation 4 CEConformit Europ enneCLSIC linical and Laboratory Standards InstituteCMVcytomegalovirusCVcoefficient of variationE

7 DTAethylenediaminetetraacetic acidEPessential principlesEQAexternal quality assuranceFMEAF ailure Mode and Effects AnalysisGHTFG lobal Harmonization Task ForceHBVhepatitis B virusHCVhepatitis C virusHIVhuman immunodeficiency virusHQheadquartersIFUinstructions for useIMDRFI nternational Medical Device Regulators ForumISOI nternational Organization for StandardizationIVDin vitro diagnostic medical deviceLEDlight-emitting diodeLOBlimit of blankLOQlimit of quantitationOQoperational qualityPOCpoint of careQA quality assuranceQASIQ uality Assessment and Standardization for Immunological measuresQCquality controlR+Dresearch and developmentR2coefficient of determinationROWrest of worldSOPstandard operating procedureTBtuberculosis4 THE MANUFACTURING COMPANY 1 SIMU POC CD4 SYSTEMWHO PREQUALIFICATION - SAMPLE DOSSIER1.

8 Purpose of the SAMPLE PRODUCT dossierThe purpose of this SAMPLE PRODUCT DOSSIER is to provide manufacturers with an example a PRODUCT DOSSIER required for WHO Prequalification of a diagnostic. The PRODUCT DOSSIER should contain evidence submitted by the manufacturer to demonstrate to WHO that the diagnostic is of acceptable quality, is safe and performs optimally when used (as intended by the manufacturer). Evidence will take the form, for example, of results of testing, certifications, standard operating procedures, systems and any other documentation necessary to support quality, safety and performance. As such, this SAMPLE PRODUCT DOSSIER contains the results of testing, extracts of standard operating procedures and other information that may be of relevance in support of an application for prequalification of a point of care (POC) CD4 diagnostic.

9 Content of the SAMPLE PRODUCT dossierThis DOSSIER is based on a fictitious diagnostic, the Simu POC CD4 System and its fictitious manufacturer, THE Manufacturing Company. As the PRODUCT and its manufacturer do not exist, any related aspect that has been described within the SAMPLE PRODUCT DOSSIER are purely for the purposes of demonstrating the type of information that may be included in a PRODUCT DOSSIER submitted to WHO Completeness of the SAMPLE PRODUCT dossierBecause of its invented nature, the information provided is considered exemplary and not necessarily the full level of detail that may be required to fulfil a WHO Prequalification requirement. At times the information is presented in summary format.

10 Additionally, the abbreviation XXX is used extensively to describe materials that do not exist, but again is incorporated to provide an example of the type of information that may be required. Further instructions are also provided in red coloured boxes to indicate where additional information may be expected. This SAMPLE PRODUCT DOSSIER is still in development and not all prequalification requirements have been addressed. WHO will continue to incorporate relevant sections. However, again it is important to note that the purpose is to provide an example and as such this SAMPLE PRODUCT DOSSIER can never be considered to represent all that evidence that may be needed to meet WHO Prequalification requirements. Each manufacturer is responsible for identifying the type and volume of evidence that will be sufficient.