Production evaluation for prequalification has four stages:
- product application pre-submission
- preparation and submission of product dossier
- dossier screening and evaluation
Dossier reviews take place once per month when a team of independent evaluators and WHO assessors assess product dossiers recently submitted by manufacturers. Each dossier must include a product test report from an-accredited laboratory.
Product application pre-submission
A manufacturer who wishes to have its product prequalified may begin the process by completing a pre-submission form, to provide basic technical and manufacturing details about the product.
Upon receipt of a complete submission form, PQS sends the manufacturer an information pack which contains the relevant performance specification and product verification protocols, as well as WHO's terms and conditions and other related material.
Preparation and submission of product dossier
A separate and complete product dossier is required for each application for prequalification. If a product is manufactured at more than one site, a separate product dossier must be submitted for the product for each of those sites.
An application dossier must include:
- complete details of the manufacturing process
- documented evidence that the product meets the performance and functional requirements detailed in the relevant performance specification
- complete manufacturing certification and licencing
For the required documentation for each product submission see the relevant PQS perfomance specification. For injection devices, manufacturers should consult the relevant manufacturer guide for the product category concerned (see drop-down box below).
Dossier screening and evaluation
Each product dossier is screened for completeness before being evaluated, to make sure that all the required information and documentation have been submitted. If the dossier is incomplete, the manufacturer will be contacted in writing and given a single opportunity to provide the missing information or material. If, after a reasonable period has elapsed, the manufacturer fails to supply the missing information or sample, the dossier will be rejected.
The dossier submission and evaluation process can be straightforward provided the dossier is complete, prepared as per the latest product specifications and all licences are up to date. If field evaluation and/or other validation of a product are required, results and/or laboratory tests outcomes must be included in the dossier.
Once a product dossier has been accepted it will undergo review by a group of technical specialists. This group is convened twice a month to review application dossiers and laboratory test results, as well as share its recommendations as to whether products meet the relevant PQS equipment performance specifications. PQS and technical specialists treat all information pertaining to a dossier evaluation with the strictest confidence.
Following dossier evaluation, PQS will inform applicants whether any clarifications or additional information is required before a final decision regarding prequalification can be taken.
Note: All applications relating to single-use injection devices will be processed strictly in accordance with the procedure described in WHO/BCT/03.09: Procedure for assessing the acceptability, in principle, of single-use injection devices for procurement by United Nations agencies.
In addition to the documentation and information provided in the application dossier, manufacturers may be required to test products using one of four laboratory testing procedures and or field-testing. The specific type of laboratory testing required for each product is defined in the relevant verification protocol and depends on the volumes that would be deployed and whether the product is safety-critical or not. The four types of testing are:
- Verified compliance: A systematic check that the manufacturing process is compliant with a specific international standard or standards. Required for medical devices that have been designed to meet the specific international standards and the manufacturing process of which is regularly verified by external certification bodies and national regulatory authorities.
- Type-examination: An inspection of a product sample. Required for items that are not programme-critical.
- Independent type-testing: An inspection and a rigorous test of a sample of the product. Required for programme-critical products.
- Full quality assurance: An inspection of the production site carried out against a pre-defined checklist. Required for complex programme-critical products involving site-specific design and on-site installation work.
All independent type-testing must be carried out by an accredited testing laboratory. Type-examination or full quality assurance can be carried out either by an accredited laboratory or by an independent specialist appointed by PQS.
In some specific cases, the results of additional testing of a product or device in its intended operating environment must be included in the application dossier. This field-testing may be needed where products or devices:
- are safety-critical or are to be used in very large quantities
- are based on technologies that are new to PQS or to immunization programmes
- require specific tests not covered under existing protocols
- require establishment of a new category
- require specific user training acceptance by end-users or operators
- have a history of technical failures.
PQS is responsible for prioritizing product types for which field-testing is either mandatory or desirable and will specify the appropriate generic testing method for each product type.
Once a product has been approved for prequalification, PQS will informs the legal manufacturer or reseller of this decision. Details of the approved product are then "published" on this website and in the PQS Product Catalogue.
Following prequalification, a product must meet a number of post-prequalification requirements in order to maintain prequalified status. Failure to do so could result in withdrawl of prequalification status.