Get An Inside Look At WHO Prequalification (who-pq) Site Inspection In L-8 @ivdmanufacturing7208

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Get An Inside Look At WHO Prequalification (who-pq) Site Inspection In L-8 @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.

Process & standards
The inspection of the manufacturing site(s) of a male circumcision device (MCD) is conducted to assess compliance of the manufacturer’s quality management system (QMS) and manufacturing practices with international standards, such as the quality management standard ISO 13485:2003 and ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes, and other relevant international standards and guidelines produced by the former Global Harmonization Task Force and the International Medical Device Regulators Forum.

However, WHO inspection of the manufacturing site will focus on the suitability of the implemented processes and procedures for the reliable supply of MCDs to WHO Member States. Therefore, customer-related issues that may be covered only in general terms in ISO 13485 are inspected in detail.

Initial inspection as part of full prequalification assessment
An initial inspection is performed in two stages:

Stage 1 inspection, usually a desk audit, will evaluate the documentation related to the QMS to ensure readiness for the stage 2 inspection. General information about the documented quality management system (including the quality manual and manufacturing processes, organigram, workflows, critical suppliers and floor plan) will be reviewed during the stage 1 inspection to establish the readiness of the manufacturer’s quality management system and to prepare for an on-site visit. Any issues of concern will be communicated to the manufacturer. A satisfactory stage 1 inspection is a precondition for proceeding to the stage 2 inspection. T
Stage 2 inspection will comprehensively evaluate the effective implementation of the QMS and production processes through an on-site inspection(s). The inspection team is composed of WHO staff, external experts (inspectors) appointed by WHO as well as, potentially, interpretors and observers. The inspectors involved in the onsite(s) inspection should have appropriate qualifications and expertise in the relevant fields, must comply with the confidentiality and conflict of interest rules of WHO, and will act as temporary advisers to WHO. Representatives of the national regulatory authorities (NRAs) and other WHO employees may accompany the inspection team to the manufacturing site(s) as observers or for training purposes.
Report on the inspection of the manufacturing site(s)


A summary of the findings of the inspection of the manufacturing site(s) will be included in the WHO prequalification public report


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




#ISO9001
#MDR2017
#production
#diagnostics
#Audit
#medicaldevice
#QMS
#IVDMANUFACTURING
#adsivdmanufacturing
#manufacturingindustries

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