Laboratory Accreditation for Product Testing

A manufacturer seeking prequalification of a product must commission an accredited laboratory to carry out tests to verify that the product complies with the relevant product performance specification when tested in accordance with the verification protocol. The laboratory’s testing report must be included in the manufacturer’s product dossier that is submitted for WHO prequalification.

PQS accredits a laboratory only if it can demonstrate that it meets the requirements of IEC 17025 to an assessment authority which is a full signatory of ILAC or an ILAC Mutual Recognition Arrangement signatory.

Thus any laboratory seeking accreditation must:

  1. Certify compliance with IEC 17025 general requirements for the competence of testing and calibration laboratories.
  2. Demonstrate competence in testing using verification protocols in the product category(s) it has selected.

Laboratories may be accredited to carry out any one, two or three types of tests:

  1. Type-examination: An inspection of a product sample. Required for items that are not programme-critical. 
  2. Independent type-testing: An inspection of the manufacturing site and a rigorous test of a sample of the product. Required for products that are programme-critical.
  3. Full quality assurance: An inspection of the production site carried out against a predefined checklist. Used for complex programme-critical products involving site-specific design and on-site installation work. 

Currently, a laboratory accredited by PQS must be selected for testing of an immunization product for WHO prequalification, although some exceptions may apply.

See Guidance Documents for performance specifications and verification protocols.