PQDx_049 v2 30 June 2014
PRODUCT DOSSIER CHECKLIST
Prequalification of in Vitro Diagnostics Programme
The attached Product Dossier contains information in support of the previously submitted Prequalification of In Vitro Diagnostics – Pre-Submission Form (Document PQDx_015) for the following product:
PQDx Number:
Product Name:
Manufacturer Name:
PQDx_049 v2 30 June 2014
WHO/MVP/EMP/RHT/PQT/2014.02
© World Health Organization 2014
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Suggested citation. Product dossier checklist - Prequalification of In Vitro Diagnostics Programme. Geneva: World Health Organization; 2014: World Health Organization; 2014.
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Letter of Agreement
The Letter of Agreement is attached as the front page of the dossier. The attestation of payment is the second page of the dossier.
Yes/No
The information concerning the product is the same on the Letter of Agreement and the Prequalification Dossier
Yes/No
4. Dossier Format
4.1. Product Dossier Submission Format
Yes/NoOne printed copy and one electronic copy of product dossier submitted
Yes/No
A signed document attesting that the content of the electronic version is an exact duplicate of the printed copy was submitted
Yes/No
Dossier is clearly presented (bound or in a clearly marked set of ring-binders)
Yes/No
4.2. Layout and Order
Yes/NoProper formatting of 1 of 2, 2 of 2, etc., used Yes/No
The submission is clearly divided into sections as described and all pages are numbered
Yes/No
Table of contents included Yes/No
This checklist is attached to the front of the submission and used as a cross-reference
Yes/No
The physical pages of the dossier and the pages numbers correspond
Yes/No There are appropriately named tab identifiers Yes/No Standard A4 paper is used for all submissions Yes/No
Font sizes are easily legible Yes/No
4.2.1. Electronic Copy Requirements
Yes/NoPage 3 of 12 PQDx_049 v2 30 June 2014
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The electronic copy is in PDF form with no password required
Yes/No
The electronic copy is organized in the same format as the printed copy
Yes/No
The name of the file is descriptive and doesn’t contain any of the noted special characters
Yes/No
The electronic copy is in PDF form with no password required.
Yes/No
4.3. Language and Units of Measurement
Yes/No English language and units of measure used Yes/NoAny translations must be carried out by a certified translator
Yes/No
5. Product
5.1. Regulatory versions of this product
Yes/NoAll regulatory versions of the product are identified and the version being submitted for assessment is
indicated
Yes/No
For all submissions, the regulatory version to which it relates is identified
Yes/No
5.2. Product description including variants (configurations) and accessories
Yes/No
The intended use of the diagnostic , testing population, user, and setting of use for the diagnostic is included
Yes/No
Photographs of all kit components, both packaged and individual, are included
Yes/No
A description of the principle of the assay
method/instrument principles of operation are provided
Yes/No
A description of the components and reactive ingredients are included
Yes/No
A description of the specimen collection and transport materials are provided
Yes/No
A description of the appropriate assay and instrumentation characteristics are included
Yes/No
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If applicable, there are descriptions of software to be used with the product, a list of variants/configurations of the product, and a description of accessories are included.
Yes/No
5.3. Essential principles (EP) checklist
Yes/NoA checklist in the form of a table that lists all relevant material is included
Yes/No
5.4. Risk analysis and control summary
Yes/NoThere is a summary report of the risks identified during the risk analysis process
Yes/No
A description of how risks have been controlled to an acceptable level
Yes/No
A signed conclusion with evidence that the remaining risks are acceptable is presented
Yes/No
There is evidence that the risk analysis is part of the manufacturer’s risk management plan
Yes/No
When applicable, specific standards/guidelines recommended by the WHO are identified
Yes/No
6. Design and manufacturing information
6.1. Product design
Yes/No6.1.1. Design Overview
Yes/NoInformation to provide a general understanding on design is provided
Yes/No There is a flowchart of the design process Yes/No
A general description of the critical assay ingredients for use with the product is provided
Yes/No If applicable, a controlling site is identified Yes/No
6.1.2. Formulation and composition
Yes/NoFor each of the ingredients, formulation/composition information is provided
Yes/No Sources of IVD component materials are identified Yes/No
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6.1.3. Biological safety
Yes/NoThere is a table, including all needed information, listing all biological components included in the product
Yes/No
If applicable, a determination of the residual risk of transmission/infection to the user is provided
Yes/No
There is information on how users of the device are informed of any residual risk
Yes/No
6.1.4. Documentation of design changes
Yes/NoRecords of each design change for the product submitted, with all pertinent information, is included
Yes/No
6.2. Manufacturing process
Yes/No6.2.1. Overview of manufacture
Yes/NoA flow chart of the entire manufacturing process is included Yes/No
A site master file, with a diagram of the floor plan, is provided
Yes/No
If applicable, certified copies of Quality Management System certificates are annexed to the dossier
Yes/No
There are details of each major step in the manufacturing process with all needed information included in the proper form
Yes/No
There is an overview of verification, validation, and quality- control activities for all stages of design and manufacture
Yes/No Batch release criteria for the product are included Yes/No
6.2.2. Sites of manufacture
Yes/NoAll critical manufacturing sites for all necessary stages of manufacture are listed with all necessary information
Yes/No
6.2.3. Key suppliers
Yes/NoAll key suppliers are listed with all needed information Yes/No
If applicable, certified copies of the key suppliers’
certificates are annexed to the dossier
Yes/No
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7. Product performance specifications and associated validation and verification studies
7.1. Analytical studies
Yes/No7.1.1. Specimen types
Yes/NoThe different specimen types that can be used with the product are identified
Yes/No
The studies needed information for support of the specimen type are included
Yes/No
The studies and needed information for support of claims made for specimen types are included
Yes/No
7.1.2. Analytical performance characteristics
Yes/No7.1.2.1. Accuracy of measurement
Yes/No7.1.2.1.1. Trueness of measurement
Yes/NoThe studies and information needed to establish trueness of measurement are provided
Yes/No
7.1.2.1.2. Precision of measurement
Yes/No7.1.2.1.2.1. Repeatability
Yes/NoThe studies and information needed to establish within-run variability are included
Yes/No
If applicable, provide studies to establish repeatability undertaken by non-laboratory personnel
Yes/No
7.1.2.1.2.2 Reproducibility
Yes/NoStudies and information to establish the appropriate types variability are included
Yes/No
The use of specimens that represent the full range of expected analyte concentration are included
Yes/No
If applicable, provide studies to establish repeatability undertaken by non-laboratory personnel
Yes/No
7.1.2.2. Analytical sensitivity
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The studies needed to establish analytical sensitivity are included with all needed information
Yes/No
If applicable, the needed parameters are provided and there are details on their derivation
Yes/No
7.1.2.3. Analytical specificity
Yes/NoThere are studies and information included that evaluate the effects of potentially interfering and cross-reacting substances/agents on the assay
Yes/No
7.1.2.4. Metrological traceability of calibrators and control material values
Yes/No
There is detailed information about the traceability of values assigned to calibrators and trueness control materials
Yes/No
7.1.2.5. Measuring range of the assay
Yes/NoStudies and information that define the measuring range of the assay are included
Yes/No
7.1.2.6. Validation of assay cut-off
Yes/NoStudies and information on how the assay cut-off time was determined are included
Yes/No
7.1.2.7. Validation of assay procedure-reading time
Yes/NoStudies and information on how the reading time was determined are included
Yes/No
7.2. Stability (excluding specimen stability)
Yes/NoThe studies and information on stability are included
Yes/NoWhen applicable, the manufacturer has looked to internationally accepted methods for determining stability of diagnostics and followed WHO
recommendations for stability
Yes/No
7.2.1. Claimed shelf-life
Yes/NoEnsure that testing is done on at least three different lots manufactured under conditions equivalent to routine production conditions
Yes/No
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The study protocol specifies acceptance criteria and testing intervals
Yes/No
Accelerated studies/extrapolated data are acceptable for initial shelf life claim, but have been/will be followed up with real time stability studies
Yes/No
If applicable, the method used for accelerated studies is identified
Yes/No
The shelf life is derived from the lot with the shortest real time stability data
Yes/No
The conclusions clearly identify claimed shelf life stability
Yes/No
7.2.2. In use stability
Yes/NoThere are studies and information for each assay component’s in-use stability provided
Yes/No
For each component, there is testing on at least one lot
Yes/No
The studies reflect routine use of the device
Yes/NoThe study protocol specifies acceptance criteria and testing intervals
Yes/No
If applicable, supporting data for calibration stability claims is provided
Yes/No
Conclusions clearly identify the claimed in-use stability
Yes/No7.2.3.Shipping stability
Yes/NoInformation needed on shipping stability studies is included. These studies are of one lot to evaluate the tolerance of products to the anticipated shipping conditions
Yes/No
Studies are done under real/simulated conditions that include variable conditions
Yes/No
The studies reflect the environmental conditions of the countries of supply, along with justification
Yes/No
The study protocol specifies acceptance criteria and testing intervals
Yes/No
If applicable, the methods of simulated conditions must be identified
Yes/No
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The results and conclusions must clearly demonstrate that the product will be effective at the end of its claimed shelf life after being subjected to the stressed conditions
Yes/No
7.3. Robustness studies
Yes/NoThere is a summary of all evidence for the robustness study(ies)
Yes/No
The test environment and its relation to the intended environment are stated
Yes/No
There is a discussion of what tests were considered for the device and why they were/were not
performed
Yes/No
There is a discussion to support why the evidence presented is sufficient to support the application
Yes/No
If applicable, there is reference to the studies and endpoints for performance studies that include human factors/usability end points
Yes/No
7.4. Clinical evidence (clinical or diagnostic sensitivity and specificity)
Yes/No
7.4.1. Clinical evaluation - manufacturer
Yes/NoAll performance claims are supported by well- designed performance evaluations that have been carried out/coordinated by the manufacturer and these studies are included with all needed information
Yes/No
7.4.2. Clinical evaluation - independent study
Yes/NoThere are details of at least one well-designed independent performance evaluation for the product under assessment
Yes/No
If applicable, publication details of the independent study(ies) is included
Yes/No
Testimonials are not included as evidence of performance
Yes/No
8. Labelling
The product dossier contains a complete set of labelling associated with the product with all four needed inclusions
Yes/No
8.1. Labels
Yes/NoPage 10 of 12 PQDx_049 v2 30 June 2014
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Copies of all packaging labels for the assay are included and contain all needed information
Yes/No
8.2. Instructions for use
Yes/NoA copy of the current instructions for use are included and these instructions include all needed information
Yes/No
8.3. Instrument manual
Yes/NoIf applicable, there is a copy of the instrument manual/associated operator manuals included
Yes/No
8.4. Any other instructional materials provided to the user
Yes/No
If applicable, any other instructional material copies are provided
Yes/No
9. Commercial History
9.1. Countries of supply
Yes/NoThere is a list of all countries in which the product under assessment is currently supplied and the year when supply started
Yes/No
For each country, detailed information about the training and support network are provided with all needed information
Yes/No
The minimum and maximum global price of supply for the product for the last financial year or included (quote in USD)
Yes/No
9.2. Adverse events and field safety corrective actions
Yes/NoA list of all adverse events within the last five years, with details of the corrective and preventive action taken, is provided
Yes/No
There is a list of all events within the last five years that required field safety corrective action
Yes/No
10. Regulatory History
If applicable, include a list of National Regulatory
Authorities that have provided current regulatory approval for the supply of the in vitro IVD under assessment, as well as the type of regulatory approval obtained, in the
countries/regions of the product authority
Yes/No
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Current evidence of the regulatory approval, such as certified copies, must be included
Yes/No
If applicable, there are details regarding any situations in which the product was rejected by a National Regulatory Authority, an application was withdrawn, or approval was withdrawn
Yes/No
Information relating the export-only regulatory approvals are clearly identified
Yes/No
11. Quality Management System
11.1. Quality manual system documents and procedures
Yes/No
There is a copy of the current version of the manufacturer’s quality manual and all needed points are addressed
Yes/No An organizational chart for the manufacturer is provided Yes/No
A complete list of all valid quality management systems documents, with needed information, is included
Yes/No
Documented procedure/s for the control of design and development changes are included
Yes/No
Documented procedure/s relevant to risk management planning and implementation are included
Yes/No
Documented procedure/s relevant to control of non- conforming goods are included
Yes/No
Documented procedure/s relevant to the control of the key suppliers are included
Yes/No
11.2. Quality management system documents
Yes/NoIf applicable, there is evidence of certification for the manufacturer of the product
Yes/No
The two previous inspection reports issued by the certification body are included
Yes/No
14. Essential principles (EP) checklist
This checklist is filled in as per the description and examples provided in the instructions
Yes/No