WHO PQS Prequalification System

Size: px

Start display at page:

Download "WHO PQS Prequalification System"

Thomas Clarke
5 years ago
Views:

1 WHO PQS Prequalification System for Injection Devices and sharps safety disposal Dr. Isaac Gobina WHO/HIS/EMP/RHT/PQT UNICEF Supply Division 29 March

2 Outline 1. Why PQS? 2. Scope of PQS 3. PQS process 4. E8 AD & E13 RUP 5. Waste management equipment E10 6. New Technologies 2

3 WHY PQS? WHO is a specialised UN agency and has a mandate to define unambiguously what product characteristics are required to meet known field conditions and requirements. UN procurement agencies: need to know that the products they are purchasing on behalf of their programmes are fit for purpose. Client countries: need to understand the performance characteristics of the products they are ordering. Industry: needs a fair basis for tendering existing products and for investing in product development. 3

4 Test Scope of PQS - three step cycle 3 functions 1. Identify programme requirements & develop and maintain performance specs and verification protocols. PERFORMANCE SAFETY improve product 2. Pre-qualify products and accredit test laboratories 3. Monitor products post-market & Prospect innovations 4

5 PQS SOPs 5

6 WHO PQS prequalification 6

7 Immunization related equipment: prequalification for UN agencies 8 categories of equipment Transport and storage of vaccines Temperature monitoring Injection devices Waste collection 7

8 4 ways of compliance verification 1. Verified compliance: A product manufactured to meet a specific international standard or standards is verified by checking systematically that the manufacturing process is fully compliant 2. Type-examination: Sample inspection is carried out against a checklist in a PQS accredited test laboratory, or by an independent expert. Used for items that are not programme-critical 3. Independent type-testing: Sample inspection and testing is carried out in a PQS accredited test laboratory. Used for products that are programme-critical 4. Full Quality Assurance: Site inspection by an independent inspector is carried out against a pre-defined checklist. Used for complex programmecritical products involving site-specific design and on-site installation work. 8

9 Laboratories accreditation Accreditation 1. ISO/IEC Information on the lab capacity and personnel 3. Details of equipment used 4. Declaration of no-conflict of interest 9

10 Prequalification scheme E008 AD E013 RUP PQS process Type examination PQS Dossier requirements 1.Information on the manufacture License Production capacity 2.Main characteristics of the product 3.QM certificate (up to date; ISO 13485:2003) 4.CE marking certificate or alike 5.Samples (verification) 6.Laboratory test results (no pass / fail) to assert compliance with ISO 7886 part 3 or 4 10

11 ISO WHO currently suspended support for the proposed change to ISO A review of evidence is underway 3. Process at ADG level 11

12 2015 WHO guide for Injection Safety By 2020 transition to the exclusive use, where appropriate, of safetyengineered injection devices with re-use prevention and sharps (needle) injury prevention. These devices should meet WHO quality standards. 12

13 13 Syringes with SIP (Sharps Injury Protection)

Novel Intradermal immunization devices in the pipeline 1.

Needle-based devices (ID adaptors, mini-needles, micro

Microneedle patches WHO PQS specification and

specifications and verification protocol being developed

14 Novel Intradermal immunization devices in the pipeline 1. Disposable-syringe jet injectors 2. Needle-based devices (ID adaptors, mini-needles, micro needles) 3. Microneedle patches WHO PQS specification and verification protocol in place for jet injectors WHO specifications and verification protocol being developed for needle and syringe based ID devices Microarray patches are at pre-clinical, and early stage clinical development for vaccine delivery 14

Safety box Defined as a single-use container

and fill line to avoid contacts with the content

15 Safety box Defined as a single-use container intended to safely hold used sharps Has a sufficient penetration resistance to avoid needle piercing Resistance to water and shocks Aperture and fill line to avoid contacts with the content Documentation in PQS website Review of specification in

Title: How to assess a PQS testing laboratory Table of Content

Title: How to assess a PQS testing laboratory Table of Content Version: 01.05 Effective date: 08/07/2004 Page: 2 of 22 Table of Content 1.0 Purpose... 3 2.0 Scope... 3 3.0 Responsibility... 3 4.0 Documentation required... 4 5.0 Procedure... 4 5.1 Assessment Register...