Post-prequalification committments and procedures ensure that WHO's endorsement of the performance, quality and safety of prequalified products 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 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 complaints, failures or other product issues to the IMD-PQS Secretariat in real time (not only during the annual review). Issues might include, but are not limited to production defects, poor performance, product recalls, reported complaints etc. Product complaints can be submitted by completing a product complaints and feedback form.

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

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

Prequalification Holders are also actively encouraged to collect user feedback, including positive performance reports, and to promptly communicate these reports to IMD-PQS via the complaints and feedback form.

2. Product change and variation reporting

A manufacturer of a prequalified product 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 or variations must be reported on the WHO e-prequalification (ePQS platform).

Important: a change to the manufacturing site or location automatically removes the prequalified status. The product must be resubmitted for prequalification evaluation and, if accepted, will receive a new IMD-PQS product code.

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 IMD-PQS and/or in collaboration with the Prequalification Unit's (PQTs) Inspections Services team.

Inspections carried out 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 an IMD-PQS Secretariat support group who contribute to the prequalification process and compliment the work of all Product Streams by organizing, coordinating and conducting inspections inspections in order to assess and verify compliance of a manufacturer / CRO / laboratory with relevant international standards and norms in connection with a prequalification application.

The aim of the inspection is to confirm Prequalification Holders' compliance with relevant good practices, international standards 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 IMD-PQS 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

IMD-PQS depends on Prequalification Holders and the wider immunization community to share feedback on the IMD-PQS prequalified products 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 IMD-PQS review procedures and throughout the procurement process at 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 IMD-PQS catalogue. This may be done at any time, in writing, to the IMD-PQS Secretariat.
2. Suspended - IMD-PQS responds to an unresolved performance issue idenitified with the product.
3. Definitively removed - The result of an unresolved 'suspension'; the product is definitively removed from the list of IMD-PQS prequalified products.
4. Made obsolete - The IMD-PQS performance specification of reference is changed 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
• if WHO received reports from the UN procurement agencies showing that production quality control is poor or inconsistent
• if the functioning of the product in the field is shown not to be meeting the performance requirements
• if 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 database of 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.