Feedback to manufacturers on Prequalification of diagnostics Dr Gaby Vercauteren Essential Health Te

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Feedback to manufacturers on
Prequalification of diagnostics Dr Gaby
VercauterenEssential Health Technologies
Diagnostics and Laboratory Technology
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PQ process- Applications, Dossier Inspections
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What is a Product Dossier?
Product Dossier (Global Harmonization Task Force)
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Purpose of the Dossier Review

• Prequalification Decision Point
• Understanding the Product
• Understanding the Manufacturer

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Elements of the Dossier

• Description of product
• Instructions for use (and labels)
• Shelf-life and stability (transport)
• Performance
• Sites of manufacture and key suppliers
• Manufacturing process
• Commercial and regulatory history
• Quality management system

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Dossier Review Report

• Provides a recommendation
• Report used by WHO inspectors
• Report used by WHO scientists

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Pilot Dossier Review

• Overall the dossier review stage was effective
• Lessons
• Need to be prescriptive
• Need to be firm
• Work with the inspection team leader

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Applications received

• 8 applications received to date
• All HIV
• Predominantly rapid test format
• Overall good standard of submission

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Application Issues

• Administrative
• Authorised Contacts
• Unrealistic Claims
• Submission of too much information
• General
• Inadequate document control
• Unclear instructions

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PQ process- Inspections
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What is a Quality Management System?

• The system should ensure consistency and
  improvement of working practices, which in turn
  should provide products and services that meet
  customer's requirements.
• ISO 9000 is the most commonly used international
  standard that provides a framework for an
  effective quality management system.

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Quality Management System
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The Standard for QMS and Quality of Product for
Medical Devices

• ISO 134852003 (Standard) Medical devices
  Quality management systems Requirements for
  regulatory purposes
• ISO 149692004 (Technical Report) Medical devices
  Quality management systems Guidance on the
  application of ISO 134852003

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Quality Management System

• Provides confidence to the organization and its
  customers that it is able to provide products
  that consistently fulfill requirements
• Requirements for products can be specified by
  the organization
• The quality of product also addressed in ISO
  13485

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International Organization for Standardization
(ISO)

• Who uses ISO 13485?
• US FDA Quality System (FDA 21 CFR Part 820)
  regulation now' harmonized' with ISO 9001 and ISO
  13485 (minor variations)
• European Union
• Health Care Canada
• TGA Australia
• GHTF Japan, Canada, Australia, US EU
• AHWP aligned with GHTF

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Terminology
Good Manufacturing Practice (GMP) "require
that domestic or foreign manufacturers have a
quality system for the design, manufacture,
packaging, labeling, storage, installation, and
servicing of finished medical devices intended
for commercial distribution in the United
States" FDA QS Regulation is contained in Title
21 Part 820 (Pre-market Notification 510(k)s)
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Purpose of the Inspection

• Verify that a quality product is consistently
  produced
• Based on international recognised standards (ISO
  13485)
• Strengthen national regulatory capacity NRA staff
• Beneficial for the manufacturer

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Inspections site visits
Inspections consist of

• Total mission - 5 days per site, 8 days per two
  sites
• 3 days on site of manufacture
• 2 days travelling time per mission
• One travel day allocated per site if 2 sites
  visited

Inspection team consists of

• One WHO DLT staff member
• 2 externally sourced inspectors
• Inspector/s from the National Regulatory
  Authority

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What is inspected?
ISO134852003 1 Scope 2 Normative references 3
Terms and definitions 4 Quality management
system including documentation requirements 5
Management responsibility including customer
focus, quality policy 6 Resource
management including human resources, work
environment 7 Product realization including
production and service provision, control of
monitoring and measuring devices 8 Measurement,
analysis and improvement including control of
nonconforming product, improvement
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Pilot Inspection

• Over all the pilot inspection was effective
• some minor non compliances
• Lessons
• Need additional time for an initial inspection
  less for follow up inspections
• Minor changes to inspection process documentation

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Inspection Reporting

• Draft inspection report to manufacturer asked
  to address non compliances
• Final report to manufacturer
• when satisfactory responses
• Summary report to website

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Potential Inspections for Diagnostics
On WHO Web buy procurement list

• 32 HIV tests and (20 rapid, 7 EIA and 5
  confirmatory)
• 53 Malaria tests (all rapid tests)
• at 40 sites of manufacture
• additional 7 manufacturers are of interest

• Rapid tests will be prioritized
• 40 sites manufacture rapid tests

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PREQUALIFICATION INSPECTION RAPID DIAGNOSTIC
TESTS CALENDAR-2009
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Planned activities 2008-10

• Ready to carry out inspections following
  prioritization of applicants and dossiers
  reviewed
• HIV tests 20-40
• Malaria tests 30-40
• Capacity building of local inspectors to
  develop/strengthen their national QMS policies
  and inspection processes
• Increase awareness to manufacturers_
  international player -gt meeting quality standards
• Post market surveillance of diagnostics

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The communication strategy

• Prequalification web pages
• Information on diagnostics that are in the PQ
  process
• FAQs
• Prequalification of Diagnostics Updates
  (quarterly)
• Annual stakeholders meeting
• Annual prequalification report
• Communications specific for
• manufacturers
• NRA - NRL
• Users
• procurers

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Thank you Prequalification of
diagnostics 4 August 2008
Diagnostics and Laboratory Technology