Table 3.
Post-prequalification activities to monitor performance of the prequalified vaccines: period 1997–2013.
| Characteristic | 1987 | 1989 | 1997 | 2002 | 2005 | 2010 |
|---|---|---|---|---|---|---|
| Post-prequalification activities | ||||||
| All lots released by NRA, release certificates to be provided upon request | ||||||
| Retention samples for testing by WHO contracted laboratories upon request | ||||||
| Reporting of changes (variations) | ||||||
| Reporting of changes (variations) with guidance on what and when to report | ||||||
| Reassessments based on site visit and testing if needed | ||||||
| Reassessment based on fully updated PSF, testing and site visit | ||||||
| Provides criteria to define frequency and scope of reassessment requirements. Site visit can be waived if criteria are met, but at least one every five years | ||||||
| Frequency and scope of reassessments based on risk analysis | ||||||
| Random testing to monitor continued compliance with specifications | ||||||
| Introduces requirement for Prequalified Vaccines Annual Reports (PQVARs) | ||||||
| Monitoring and investigation of complaints and reports of AEFI | ||||||
| Recommendations for action in case of non-compliance | ||||||