What is the Product Dossier in WHO Prequalification of IVD (WHO-PQ) |Lecture-6@ivdmanufacturing7208

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What is Product Dossier in WHO Prequalification of IVD (WHO-PQ) |Lecture-6@ivdmanufacturing7208

WHO in vitro diagnostics (IVDs) prequalification primarily benefits underserved populations in low- and middle-income countries — that have little or no domestic regulatory frameworks for IVDs — and whose need for diagnosis, initiation and monitoring of treatment for high-burden diseases is considerable.

It also supports procurers, regulators, laboratories, manufacturers and donors, in reaching national and international public health objectives.

Product Dossier

WHO sample product dossiers illustrate the type of evidence that must be submitted by a manufacturer ― when seeking WHO prequalification ― in order to demonstrate that the product is of acceptable quality, is safe and performs optimally when used (as intended by the manufacturer).


Manufacturers must not submit a product dossier together with the pre-submission form. Dossiers that are submitted in the absence of a formal request from WHO will be destroyed without prior notice.
Invitation to submit a product dossier
For a prequalification assessment of a male circumcision device (MCD), WHO will formally invite the manufacturer to submit a product dossier together with a signed letter of agreement and proof of payment of the dossier screening fee.

About the dossier
The manufacturer is expected to prepare, and either hold or provide timely access to, technical documentation that shows how each male MCD was developed, designed and manufactured. This technical documentation, typically controlled in the manufacturer's quality management system (QMS), is often extensive and sections of it may be held in different locations. The documentation is revised to reflect any changes made during the life cycle of the MCD through normal application of the manufacturer's QMS.

The product dossier is a selection of records and documents from this entire collection of records and documents that a manufacturer holds for a particular product. Manufacturers compile a product dossier from their existing technical documentation to provide evidence.

Screening
Manufacturers must ensure that the content of the product dossier is consistent with the information submitted in the application form and that any changes in the information submitted in or as part of the application form are promptly notified in writing to WHO. The product dossier should only include information in support of the product name, product code(s), regulatory version and manufacturing site(s) indicated as eligible by WHO.

Components of assessment
The prequalification assessment process for MCDs includes the following components:

review of the application form;
review of the product dossier, including review of clinical evidence;
inspection of the manufacturing site(s);
labelling review.
Dossier review
WHO reviews the product dossier to:

assess the product and how it performs
assessing the product manufacture
determine whether the manufacturer's QMS is of an adequate standard to warrant a WHO prequalification site inspection.
Review of clinical evidence


The Essential Principles of Safety and Performance of Medical Devices of the International Medical Device Regulators Forum include essential safety and performance criteria for a medical device that allow the manufacturer to demonstrate that the product is suitable for its intended use.


Dossier Screening
Dossier Review
Site Inspection
Labelling Review
Performance Qualification
Product Dossier

List of Queries-
What is WHO Prequalification of In Vitro Diagnostics Product ?
What is WHO-PQ IVDs?
What is the benefits of WHO-PQ?
WHO-PQ IVDs kya hota hai ?
WHO-PQ kya hai ?
World Health Organization PQ kya hai?
WHO-PQ Guidelines ?
WHO-PQ Product
Prequalified List pf IVD Products
General information – WHO List of Prequalified In Vitro Diagnostic Products
In Vitro Diagnostics Eligible for WHO Prequalification
Eligibility principles
Eligibility criteria
IVD products currently eligible for submission for prequalification
Prequalification Procedures and Fees: In Vitro Diagnostics
Who can participate in WHO prequalification of IVDs?
What are the steps of IVD prequalification?
Full assessment or abridged assessment
What happens when an IVD is prequalified?
Duration of validity of prequalification status
Post-prequalification
Prequalification fees
Prequalification Reports
Public Reports




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