Post-prequalification committments and procedures ensure that WHO's endorsement of the performance, quality and safety of prequalified immunization devices remains valid.

Once a product has been prequalified, and as long as no serious complaints have been received from product users, it will maintain its prequalified status for up to 12 months, or until the next scheduled annual review of products (whichever occurs first).

Performance reporting, variations & QMS obligations

1. Complaints and failures reporting

Prequalification Holders are obliged to report all complaints, product defects and failures to the WHO Immunization Devices Secretariat as soon as the information comes to their attention ("in real-time"). Complaints review and management is a strictly confidential process between WHO Immunization Devices and the Prequalification Holder.

Issues might include, but are not limited to, production defects, poor performance, product recalls, reported complaints etc. Product complaints, defects and failures should be submitted using the dedicated IMD-PQS product complaints and feedback form.

Reports of performance issues or failures will NOT automatically lead to the suspension of a product's prequalified status. 

E003 Taxonomy: When reporting equipment failures or complaints Prequalification Holders of category E003 products (ONLY) are required to refer to the WHO IMD-PQS Post-market Monitoring (PMM) Taxonomy (EN) / Taxonomie en Français (FR).

Prequalification Holders are also actively encouraged to collect user feedback, including positive performance reports, and to promptly communicate these reports to WHO Immunization Devices using the complaints and feedback form.

2. Product change and variation reporting

Prequalification Holders must also keep WHO fully informed, in real time, about any administrative or technical changes, including but not limited to changes made to the:

• product itself
• manufacturing process of the product
• manufacturing site of the product.

Post-prequalification product changes ("variations") should be submitted via email to the WHO Immunization Devices Secretariat: Isaac Gobina (gobinai@who.int), Paul Mallins (mallinsp@who.int) and Lauren Goodwin (lgoodwin@who.int). 

Important: a change to the manufacturing site or location automatically removes the product's prequalified status. The product must be resubmitted for evaluation and, if successfully prequalified, will receive a new IMD-PQS product code ("E0XX-XXX").

3. Quality assurance & CAPAs

Prequalification Holders are expected to ensure quality assurance and/or implement corrective and preventative actions (CAPAs) as needed, as a part of their quality system.

In addition to collecting performance reports and product defect reports, Prequalification Holders are required to analyse product performance information: a requirement of quality management systems as stipulated by the International Standards Organization (ISO)

Inspections

In cases where inspections are necessary, they may be carried out by WHO Immunization Devices and/or in collaboration with the Prequalification Unit's (PQTs) Inspections Services team.

Inspections of Prequalification Holders are predominantly Quality Management Systems (QMS) compliance verifications related to ISO/IEC 9001 (categories E001, E002, E003, E004, E005, E006, E007, E010) and ISO/IEC 13045 (categories E008 and E013), and/or quality issues and complaints.

Inspection Services consists of a team of expert investigators and a WHO Immunization Devices Secretariat support group. These actors contribute to the prequalification process and compliment the work of all Product Streams by organizing, coordinating and conducting inspections.

The aim of the inspection is to confirm the compliance of Prequalification Holders', CROs and laboratories with relevant good practices, international standards and norms, and adherence to information submitted in the prequalification application. Inspections may be carried out:

• via an initial on-site inspection, or
• by leveraging the outputs of inspections conducted by national regulatory authorities operating to equivalent standards and stringency to those of WHO, or
• in addition, Inspection Services may conduct subsequent inspections to verify that a product-related site continues to be compliant with the required norms and standards.

The inspection process is conducted either directly with the WHO Immunization Devices Secretariat or via formal correspondence with WHO Prequalification Inspection Services.

Further information regarding Inspection procedures is available on the WHO Prequalification Inspection Services website.

Inspections are conducted on a full "real cost recovery" basis (the Prequalification Holder is required to reimburse the cost of the inspection).

Prequalification Holder Commitments - post-PQ procedures

WHO Immunization Devices depends on Prequalification Holders and the wider immunization community to share feedback on WHO-prequalified immunization devices in order to fulfill its mission to ensure the availability of quality, reliable products for the storage, transport and administration of prequalified vaccines for national immunization programmes.

The performance of prequalified products is continually reviewed through the formal WHO Immunization Devices review procedures, and throughout the procurement processes of the UN and other procurement agencies.

Prequalification Holders agree to fulfill three types of post-prequalification commitments:

• Post-market monitoring (PMM) requirements
• Annual Review of prequalified products
• Extra-ordinary review process (if required)

Loss, suspension or withdrawal of prequalified status

A product's prequalified status may be lost or removed in several ways. The status may be:

1. Withdrawn - The Prequalification Holder decides to remove the product from the WHO Immunization Devices ("PQS") Catalogue. This may be done at any time, in writing, to the WHO Immunization Devices Secretariat.
2. Suspended - WHO Immunization Devices responds to an unresolved performance issue identified with the product.
3. Definitively removed - The result of an unresolved 'suspension'; the product is definitively removed from the Catalogue of WHO-prequalified immunization devices.
4. Made obsolete - The WHO Immunization Devices performance specification of reference is revised or withdrawn/replaced and the product's technical specifications are not updated accordingly.

Typical reasons that could lead to the loss or removal of prequalified status include:

• a change in the manufacturing site with or without notifying WHO of the intention to do so
• a change to the product in an unacceptable way (one that negatively affects the performance of the product) with or without notifying WHO of the intention to do so
• a failure on the part of the Prequalification Holder to provide evidence of annual license renewal(s) for the product, or any other relevant time expiring documentation
• WHO received reports from the UN procurement agencies showing that production quality control is poor or inconsistent
• the functioning of the product in the field is shown to not be meeting the performance requirements
• the Prequalification Holder enters into bankruptcy or receivership.

In the case of minor concerns, the Prequalification Holder will be requested to provide relevant information to WHO. If this is satisfactory, prequalified status will be reinstated.

In the case of major concerns, the product will be suspended from the Catalogue of WHO-prequalified immunization devices until the Prequalification Holder either satisfies WHO that quality issues have been addressed, successfully re-tests the product in response to performance concerns, or voluntarily withdraws the product. Prequalification Holders have up to six months in which to address the ground(s) of suspension.