THIS IS UNFPA - extranet.who.int · •New format essentially combines the Product Dossier and Site Master File •Reduces duplication of information •In line with conventional

THIS IS UNFPA

WHO/UNFPA Prequalification Programme

Guidance for RH Devices (Condoms and IUDs)

UNFPA Procurement Services Branch

Focus Areas

Transactional procurement for UNFPA COs and external clients

Emergency procurement and management of

inventory

Strategic Procurement

Cluster

Quality Assurance,

including pre-qualification programmes

Capacity building in procurement

Supply chain coordination

WHO/UNFPA Prequalification Programme

• Prequalification programmes started in 2001 (WHO’s normative and standard setting role)

• In 2008 it was agreed that UNFPA will manage the prequalification of condoms and intrauterine devices

• UNFPA aims to evaluate all suppliers that express interest

Aims of the Prequalification Programme

• Establish a system that promotes the procurement of good-

quality products that conform to the latest edition of the international

standard and the WHO/UNFPA Specification, and that retain their

effectiveness through out their stated shelf-life;

• Ensure that manufacturers have effective quality management

systems in place and meet quality standards

• Determine the physical capacity of manufacturers to deliver required

quantities of products

• Enhance confidence in ability of manufacturers to meet all

requirements and reduce the level of associated risk

• Save time and resources in identification of reliable manufacturers

1•Response to Expression of Interest and Documentation Submission

2• Screening of Submission

3•Document Review

4•On-site inspection

5•Product Testing

6 •Prequalifcation/Corrective Actions

7•Maintenance of Prequalification Status

Prequalification Programme StagesPrequalification Programme Stages

Changes to Prequalification Programme for RH Devices

• PQ Guidance document is separate from the technical specification and operational guidance for product

• Harmonize PQ document submission with Summary of Technical Documentation ( STED) • Separate Product Dossier and Site Master File no longer required • Only soft copies of document • To be implemented 2018 for male condoms ( based on draft document)

• Issuance of quality alerts and Notices of Concerns to notify National Regulatory Agencies and international procurers of quality and safety issues

• Public Inspection Reports (under development)

Summary of Technical Documentation

• New recommended format is based on the STED • Summary of Technical Documentation for Demonstrating Conformity to the

Essential Principles of Safety and Performance of Medical Devices) developed by the Global Harmonization Task Force (GHTF), a voluntary consortium of representatives from medical device Regulatory Authorities and Trade Associations from around the world

• Widely accepted by major regulatory agencies around the world

• The format has been amended to reflect the specific requirements of the WHO/UNFPA Prequalification process• New format essentially combines the Product Dossier and Site Master File• Reduces duplication of information• In line with conventional medical device technical files

Contents of STED (1)

• Characteristics of the product(s)

• Regulatory approvals

• Raw materials

• Product specifications

• Evidence of compliance with WHO/UNFPA general requirements

• Stability data

• Labelling and information

• Risk management analysis • Plan/Procedures• Report

Contents of STED (2)

• Manufacturing information • Site details• Certificates• Production processes• Premises and equipment• Personnel

• Quality Management System• Document management• Records• QA procedures• Distribution, complaints and product recall procedures• Internal audit procedures• CAPA procedures• Design and development procedures

Documentation Submission

Document Submission

• Manufacturers respond to Expression of Interest • Cover Letter

• Summary of Technical Documentation (STED)

• Copies of certificates/licenses

• Soft copies of documentation

• 10 Product samples may be required.

Screening

Purpose: Completeness of submissions

Resources and tools:

Screening template

WHO/UNFPA operational guidance on prequalification

Outcome communicated with manufacturer

If complete, proceed to detailed technical review

If incomplete, manufacturer will be asked to complete the documentation and resubmit within a specified period of time

Document Review and Inspection

Conducted by technical experts, two for each

submission

Assessors and Inspectors

• Experts with relevant years of experience in condom/IUD production, QA, Medical devices And

• Relevant qualifications in science e.g. chemistry, pharmacy

• Services procured through international bidding process

Confidentiality

Declaration of conflict of interest

Document Review

Purpose: To establish manufacturer has appropriate manufacturing

processes and quality management systems in place and conforms to

requirements of the respective WHO/UNFPA Specification and ISO

Standards

• ISO 4074 – male condoms

• ISO 25841- female condoms

• ISO 7439 – IUDs

- Biocompatibility testing according to ISO 10993

- Risk Management plan according to ISO 14971 and ISO 13485

- Confirm products have adequate shelf life data

On – Site Inspection

Verifies information from the document submission

Inspectors look at all parts of production process • Raw materials to final product warehouse

Suitability and state of the equipment are considered

Batch Documentation

Quality System

Validation

Maintenance

Laboratories

Shelf life • Detailed results reviewed on site and compared with submitted information

• In accordance with ISO standard? Data consistent? Protocols adequate?

ISO 13485 Audit and PQ Inspection Differences

Inspectors check certification but don’t fully

repeat ISO 13485 audit

PQ inspection is mainly technical inspection

Half of time is spent in factory or laboratory

Inspectors work through the manufacturing

process

Sampling and Testing

Product samples taken during the inspection from

randomly selected batches

Sample size in accordance with ISO 2859 standards

Range of tests conducted in accordance with relevant

WHO/UNFPA Specification and ISO standard

Testing conducted by independent, competent testing

laboratories (ISO 17025) appointed by UNFPA

Copy of test report provided to manufacturer

Inspection Report and Outcome

• Inspection report with test results provided to manufacturer

• Based on document review and inspection UNFPA recommends:•Prequalification without conditions

•Prequalification subject to specified corrective and preventative action ( CAPA)*

•Site ineligible for prequalification

• CAPA - Manufacturer Response

• Findings raised by inspectors will require a verified a CAPA before the factory can be prequalified

• CAPA report should be submitted within 90 days of final inspection report through UNFPA and cover all issues raised by inspectors

• CAPAs should contain evidence ( photographs, copies of amended documents etc) where appropriate to allow the CAPA to be verified

Outcomes of Prequalification

Outcome is posted on UNFPA’s website

• List of prequalified MLC manufacturers

• List of prequalified FC manufacturers

• List of prequalified IUD manufacturers

Maintenance of Prequalification

Notification of Changes:

Once manufacturing sites are prequalified, applicant/manufacturer is required to

advise UNFPA within 4 weeks of any matter that affects the information on which the

approval was based.

Reassessment:

Every 3 years prequalified factories must be re-assessed to maintain their

prequalification status. This re-assessment consists of:

1. Document review

2. On-site inspection

3. Product testing