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Evaluation of the application
from Post Consultation document for the establishment of a Pre-Qualification procedure for vaccines
by EuFMD
THE PRODUCT SUMMARY FILE (PSF) FOR A FOOT-AND-MOUTH DISEASE VACCINE
At least, the following parameters should be controlled:
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- Inactivation kinetics: During inactivation, the virus titre is monitored by a sensitive and reproducible technique. The inactivation procedure is not satisfactory unless the decrease in virus titre, plotted logarithmically, is linear and extrapolation indicates that there is less than 1 infectious virus unit per 104 L of liquid preparation at the end of inactivation.
- Inactivation test: no residual live FMD virus should be detected.
- Residues of inactivating agents. Appropriate tests are carried out to demonstrate that the inactivating agent has been removed or reduced to an acceptable residual level.
- FMDV antigen mass (146S) content: The 146S antigen content of each batch of bulk inactivated antigen is determined by an in vitro method (for example, by sucrose density gradient centrifugation and ultraviolet spectrophotometry at 259 nm or other validated method).
- Sterility test: o bacterial and fungal test; o viral testing where testing of the virus seed has not been performed and shown to be free of extraneous agents.
2.E Controls on Finished Product
Section 4. ‘Final product batch tests’ of Chapter 3.1.8. of the OIE Manual has to be taken into account.
List the routine tests performed and specifications for the final product. Concise descriptions of the method and retest criteria are acceptable but full standard operating procedures in English should be made available on request. In addition, appropriate validation of the tests performed should be provided.
The following tests should be performed:
2.E.1. General characteristics of the finished product
The tests of general characteristics shall, wherever applicable, relate to the control of volume and maximum deviations, appearance, to mechanical, physical or chemical tests, physical characteristics such as density, pH, viscosity, etc. For each of these characteristics, specifications, with appropriate confidence limits, shall be established by the applicant in each particular case.
