Guidance and training
Guidance for Manufacturers
1. Technical Guidance Series
The Prequalification Team – Diagnostics is developing a Technical Guidance Series for manufacturers interested in WHO prequalification of their IVD. The guidance will apply in principle to all IVDs that are eligible for WHO prequalification for use in WHO Member States and will assist manufacturers in meeting prequalification requirements. It has been developed by WHO with input from national regulatory authorities, national reference laboratories and WHO prequalification dossier assessors and inspectors. It should be read in conjunction with relevant international and national standards and guidance.
- TGS 1 Standards applicable to the WHO Prequalification of in vitro diagnostics: TGS-1 identifies standards and guidance that contains valuable information on a range of issues that are encountered in the manufacture, verification, and validation of IVDs.
- TGS 2 Establishing stability of an in vitro diagnostic for WHO Prequalification: TGS-2 provides IVD manufacturers with guidance on possible approaches to determine stability. More specifically it describes the requirements for WHO prequalification in terms of stability testing. (Comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
2. Sample Product Dossier for WHO Prequalification
The Prequalification Team – Diagnostics have prepared sample product dossiers based on a fictitious diagnostics to provide manufacturers with an example of the type of information that may be included in a product dossier submitted to WHO Prequalification.
WHO Prequalification: Sample Product Dossier for a CD4 IVD
WHO Prequalification: Sample Product Dossier for an IVD intended for HIV self-testing
Comments table for sample product dossier for an IVD intended for HIV self-testing. (Comments to be submitted to email@example.com no later than 29 February 2016)
Guidance for WHO Member States
The Prequalification Team - Diagnostics aims to provide guidance & specific training programmes for WHO Member States on a regional basis.
Areas to be covered
- Advocacy and policy guidance for Ministries of Health and
laboratory experts at regional and country level.
- Training the "Trainers"
- Quality Assurance
- Organisation of EQAS
- CD4+ Counting Skills
- Country Project – An East African Initiative (AMREF) Implementation of Basic Operational Frameworks to improve the quality of laboratories in Kenya, Uganda and United Republic of Tanzania.
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
G6PD Prequalification: Public Announcement to Stakeholders
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to email@example.com no later than 29 February 2016)
Newsletter Issue 13, Q1 2016
Guidance for post-market surveillance
Prioritization criteria expanded to HPV